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OTC & Biosimilar Directory 2010

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Top OTC and Biosimilar developers seeking marketing partners

Top OTC and Biosimilar developers seeking marketing partners

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  • 1. OTC & Biosimilar See our Global Generic Licensing Directory for over Directory Supplement 7000 DOSSIERS or visit Edition 1, 2010 www.genericlicensing.com Please contact us now to receive a booking form Email: directory@genericlicensing.com or Phone: +44 8707524105 © Copyright 2008-2009
  • 2. OTC & Biosimilar Directory Supplement OTC COMPANY LIST Services Offered FEATURED COMPANY Geiser Pharma ✔ Regulatory filings, variations and license maintenance ABC Farma ✔ Dossier creation, formatting and auditing (NTA, CTD, eCTD, ANDA) Biogened ✔ Manufacturing GMP inspection preparation Bioxtract Diapharm ✔ Manufacturing technical transfers EMS ✔ Formulation development projects Farmalider Helvetia Pharma Europe – North America – Australasia Oystershell Expertise is offered both in-house and through industry leading partners. Progressare Talk to us about your technical service requirements today. CALL +44 (0)870 7524105 CLIENT.CARE@GENERICLICENSING.COM Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
  • 3. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE FEATURED COMPANY: Geiser Pharma COMPANY NAME Geiser Pharma is a pharmaceutical company dedicated to developing both generic and Geiser Pharma OTC products purely to be out-licensed to third parties. Apart from our own developments, Geiser Pharma offers its partners the possibility to increase their R&D capacity through CITY outsourcing our R&D services, allowing partners to have access to value added Product name Carbocysteine Lysine Syrup Product name Pharma lozenges with Lidocaine Pamplona technologies. Category OTC Category OTC Ingredients 2,7 g Carbocysteine Ingredients 2,0 Lidocaine / 1,2 mg Dichlorobencilic COUNTRY Contact Preson: Lourine Lenderink (llenderink@geiserpharma.com) Use/Claim Mucolytic that reduces sputum viscosity Alcolhol / 0,6 mg Amylmetacresol Spain Contact Telephone Number: 0034 948 101943 / 0034 607 616 045 Main Indication Cough & Cold Use/Claim Pharma lozenges with topical anesthetic Unit Size 20 sachets / unit effect PACK SHOTS Status Under development Main Indication Sore throat relief Sold In (Countries) T.B.D. Unit Size ALU blister containing 24 lozenges Status Under development Sold In (Countries) T.B.D OTC PRODUCTS Product name Stick Pack Doxylamine Succinate Product name Stick Pack Ranitidine Product name Pharma lozenges Product name Vegetal Laxative Category OTC Category OTC Category OTC Category OTC Ingredients 12,5 / 25,0 mg Doxylamine Succinate Ingredients 75 / 150 mg Ranitidine Ingredients 1,2 mg Dichlorobencilic Alcolhol / 0,6 mg Ingredients Rhamnus Frangula, Rhamnus Pushianus, Use/Claim Night time sleep aid. Hygroscopic formulation Use/Claim Hygroscopic formulation that inhibits stomach Use/Claim Amylmetacresol Fucus Thallus which allows product to dissolve directly in acid production. No water needed. Pharma lozenges with topical anesthetic Use/Claim 100% vegetal laxative, indicated for diabetics the mouth. No water needed. Main Indication Heart burn effect Main Indication Constipation Main Indication Insomnia Unit Size 10 Alu Foil sticks / box. Pre-cut opening, Main Indication Sore throat relief Unit Size PVC / ALU blister containing 2 x 20 capsules Unit Size 10 Alu Foil sticks / box. Pre-cut opening, child proof. Stick size 70 x 23 mm Unit Size ALU blister containing 24 lozenges Type 0 child proof. Stick size 70 x 23 mm Status Under development Status Under development Status Available Status Under development Sold In (Countries) T.B.D. Sold In (Countries) T.B.D Sold In (Countries) T.B.D Sold In (Countries) T.B.D.
  • 4. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name High Hyalplus Product name Ice Cold Pain Relief Patch Product name Hypertonic Sea Water Earspray Product name Earspray Special Babies Category Medical Device Category Medical Device Category Medical Device Category Medical Device Ingredients Injectable Sodium Hyaluronate 2 ml / 20 mg Ingredients Natural Menthol (5%) Ingredients Sea Water Ingredients Sea Water Use/Claim HA for pain relief and decreasing of synovium Use/Claim Pain relief cooling therapy Use/Claim Safest alternative to cotton buds for a regular Use/Claim Safest alternative to cotton buds for a regular inflammation. Main Indication Pain relief risk-free ear hygiene risk-free ear hygiene in young children Main Indication Pain relief Unit Size 5 patches in resealable pouch. Patch size Main Indication External auditory canal hygiene Main Indication External auditory canal hygiene Unit Size Prefilled syringes 10 x20 cm Unit Size 50 ml metallic flask, innovative nozzle Unit Size 50 ml metallic flask, innovative nozzle Status Available Status Available Status Available Status Available Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Product name Warming Patch Product name Hydrating vaginal gel Product name Icy Pads forehead cooling pads Children Product name Luteine + Multivitamin Soft Gel Capsules Category Medical Device Category Medical Device Category Medical Device Category Food supplement Ingredients Iron powder, activated carbon, water and salt Ingredients Cranberry / chamomile extract Ingredients Menthol oil, Lavender oil, Eucaluptus oil Ingredients Multivitamins + Luteine Use/Claim 8 hours of constant and penetrating heat that Use/Claim Pharma quality hydrating vaginal gel with Use/Claim Soothing cooling relief for fever discomfort & Use/Claim Soft gel capsules containing Luteine, relaxes tense and contracted muscles cranberry extract, paraben free. Reliefs headaches during 6 hours to children Main Indication vitamins and essential fatty acids Main Indication Pain relief vaginal dryness and facilitates sexual Main Indication Pain relief Sight Care Unit Size Patch size 15 x 10 cm / 22 x 10 cm. 2 intercourse. Unit Size 2 x 2 pads per unit. Pad size 5 x 12 cm. Unit Size Alu blister 2 x 15 / 4 x 15 soft gel capsules patches per unit Main Indication Female Hygiene Status Available Status Available Status Under development Unit Size Innovative dispenser with valve, 30 ml Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Status Available Sold In (Countries) T.B.D.
  • 5. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Thermal Spring Water Tooth Paste Product name Thermal Spring Water Sensible Gums Product name Thermal Spring Water Tooth Paste Junior Product name Thermal Spring Water First Teeth Category Cosmetic Category Cosmetic Category Cosmetic Category Cosmetic Ingredients 1100 ppm Fluor Ingredients Thermal spring water Ingredients 1000 ppm Fluor Ingredients Spring water, Chamomile Use/Claim Thermal spring water tooth paste / 1100 ppm Use/Claim Toothpaste gel provides a gentle care for Use/Claim Specifically designed for children between 7 Use/Claim Thermal water teething gel with natural, Fluor sensitive gums, weakened teeth, or teeth with and 12 years old to prevent tooth decay in soothing and anti-irritating properties. Main Indication Dental Hygiene eroded enamel. Mentholated gel helps permanent teeth. Mint flavour. Marshmallow flavour. Chamomile extract. No Unit Size 75 ml Polyethylene tube HDPE reduce occasional bleedings and gingival or Main Indication Dental Hygiene sugar. No alcohol. dental sensitivities. No fluoride, paraben free. Unit Size 50 ml Polyethylene tube HDPE Main Indication Dental Hygiene Status Available Main Indication Dental Hygiene Available Unit Size 50 ml Polyethylene tube HDPE Sold In (Countries) T.B. D Status Unit Size 75 ml Polyethylene tube HDPE Status Available Sold In (Countries) T.B. D Status Available Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Product name Thermal Spring Water Tooth Whitener Product name Thermal Spring Water Mouth Spray Product name Greaseless Balsamic Decongestive Product name Thermal Spring Water Tooth Paste & Care Category Cosmetic Menthol Chest Rub Children Category Cosmetic Ingredients Thermal spring water Category Cosmetic Category Cosmetic Ingredients 1100 ppm NaF Use/Claim Thermal spring water mouth spray for Ingredients Camphor, Eucalyptus, Menthol Ingredients 250 ppm Fluor Use/Claim Thermal spring water dental whitening tooth sensible gums, dry mouth, bad breath Use/Claim Pharma quality non greasy decongestive Use/Claim Prevention of tooth decay in temporary teeth. paste / 1100 ppm NaF Main Indication Dental Hygiene menthol chest rub, paraben free The stabilized alkaline pH of the Thermal Main Indication Dental Hygiene Main Indication Cough & Cold spring water neutralises acids and reinforces Unit Size 200 ml metallic flask, 2 application devices Unit Size 75 ml Polyethylene tube HDPE Unit Size 50 ml, Flip Top or normal Polyethylene tube, the brushing action for an improved efficiency Status Available against tooth decay. Mango flavour. Status Available diam. 35 mm HDPE Sold In (Countries) T.B. D Status Available Main Indication Dental Hygiene Sold In (Countries) T.B. D Sold In (Countries) T.B. D Unit Size 50 ml Polyethylene tube HDPE Status Available Sold In (Countries) T.B.D.
  • 6. OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME Abc Farma Internacional is chiefly engaged in the development and design of new ABC Farma technologies for application in the cosmetics and pharmaceutical industry. Specialised in the manufacturing and distribution of the transdermal and topical patches, Fast-Edible CITY medical films, mechanical action strips, impregnated masks, Wet wipes, technological Barcelona fabrics loaded with medical or cosmetic ingredients as well as Hyaluronic acid products. COUNTRY Contact Preson: Anna Guimerá (aguimera@abcfarma.com) Spain Contact Telephone Number: 0034 93487 9670 / 00 601 18 65 11 mobile PACK SHOTS ~ Approved & In-development ~ THE INDUSTRY’S FIRST PRINTED DIRECTORY OF PRODUCTS AVAILABLE FOR LICENSING 7000 PRODUCTS • Delivered to sales, marketing & in-licensing teams worldwide OTC PRODUCTS Product name Category Capillari HAIR LOSS PATCH Cosmetic Product name Category FÒRFORA PLUS Cosmetic Ingredients Adenosine, Cysteine, Ruscus, Bamboo, Serenoa Ingredients Copaifera Officinalis, Brasil Nut, Vitamin E, • Detailed product information (generic name, form, strength...) Serrulata, Vitis Vinifera Vitamin B, L-Cysteine Use/Claim • Extra dossier information (dossier format/status, regulatory status...) The main objective it is to fight hair loss. Its Use/Claim It is a novel product with action Anti-dandruff components have a direct impact on the formation for exclusive use by the dermatologist. EDITION 2 NOW OUT, EDITION 3 OUT MARCH 2011 of hair and blood circulation at the scalp, thus Main Indication Dermatitis seborrhea avoiding so the weakest hairs fall down Unit Size 2 sachets (56 p.), 2 months treatment Email NOW to purchase a copy and advertising rates Main Indication To prevent hair loss Status Full develop Unit Size 2 sachet (56 p.), 2 months treatment Sold In (Countries) In various EU, Russia Email: directory@genericlicensing.com or Phone: +44 870 752 4105 Status Full develop Sold In (Countries) In various EU, Russia DIRECTORY.GENERICLICENSING.COM
  • 7. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name ABBRONZANTE QUICK SUN PATCH Product name LEGPATCH Tired Legs Product name QUELOPATCH Product name CICADIL Category Cosmetic Category Cosmetic Category Cosmetic Category CE mark IIB Ingredients μeta-carontene, Tyrosine, Lutein, Lycopne, Ingredients Ruscus aculeatus, Centella Asiatica, Horse Ingredients Laluzero. Special Hyaluronic acid having a Ingredients Laluzero. Special Hyaluronic acid having a Vitamin E Chestnut, Vaccinium Myrtillus molecular weight lower than 50 KDa and solution molecular weight lower than 50 KDa and Use/Claim To enhance the natural defences of skin against Use/Claim It has a firming action, strengthen and viscosity close to zero. solution viscosity close to zero. the sun and mitigate the effects of aging Refreshing of the skin of the legs Use/Claim Quelopatch Scar Reducer is specially designed Use/Claim Lesions: Barrier function sterile gauzes Main Indication Patch for a more efficient and safer exposition to Main Indication Fatigued legs: Patch that relieves swelling to help the scar to regain its function and preventing additional infection and improving UV rays and heaviness appearance go back to being normal skin. the healing process Unit Size 4 sachets (56 p.), 2 months treatment Unit Size 01 sachet 28 patches, 01 month treatment Main Indication Scars treatment Main Indication Sterile Gauze for breached skin Status Full develop Status Full develop Unit Size 1 sachet (2 p.) Unit Size Consumer unit of 20 sterile gauze in a twin Sold In (Countries) Iberia, Italy, Fr, Mx Sold In (Countries) Iberia, Italy, France Status Full develop sachet Sold In (Countries) Spain, Italy Status Full develop Sold In (Countries) Spain, Italy Product name IALUPATCH Product name PSORIPATCH Product name IALURAPID ZERO Vaginal Douche Product name IALURAPID ZERO Gel Category CE mark class 1 Category Cosmetic Category CE mark class 2a Category CE mark class 2a Ingredients Laluzero. Special Hyaluronic acid having a Ingredients UREA, ALOE VERA, IALUZERO® Ingredients Laluzero. Special Hyaluronic acid having a Ingredients Laluzero. Special Hyaluronic acid having a molecular weight lower than 50 KDa and solution (Hyaluronic Acid), Mangnesio Ascrobil fosfato molecular weight lower than 50 KDa and solution molecular weight lower than 50 KDa and viscosity close to zero. Use/Claim It is a patch of Hydro gel to treat the plaques viscosity close to zero. solution viscosity close to zero. Use/Claim Specially designed to help the skin to regain its of psoriasis and the scales Use/Claim Intimate cleansing: first aid solution for vaginal Use/Claim Provides hydration protection and hygiene functionality and appearance following the Main Indication Dry and scaling skin irritation and small lesions mucosa damaged or injured formation of a scar. Thanks to H.A. helps reduces 1 sachet (3 p.) Main Indication Intimate cleansing Main Indication Daily vaginal moisturizing gel Unit Size the time of the physiological healing process. Unit Size 3 uds. (30 ml.) Unit Size 1 unit (50ml) Status Full develop Main Indication Stretch mark Status Full develop Status Full develop Sold In (Countries) Spain, Italy Unit Size 1 sachet (2 p.) Sold In (Countries) Spain, Italy Sold In (Countries) Spain, Italy Status Full develop Sold In (Countries) Spain, Italy
  • 8. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name ABBRONZANTE QUICK SUN PATCH Product name LEGPATCH Tired Legs Product name QUELOPATCH Product name CICADIL Category Cosmetic Category Cosmetic Category Cosmetic Category CE mark IIB Ingredients μeta-carontene, Tyrosine, Lutein, Lycopne, Ingredients Ruscus aculeatus, Centella Asiatica, Horse Ingredients Laluzero. Special Hyaluronic acid having a Ingredients Laluzero. Special Hyaluronic acid having a Vitamin E Chestnut, Vaccinium Myrtillus molecular weight lower than 50 KDa and solution molecular weight lower than 50 KDa and Use/Claim To enhance the natural defences of skin against Use/Claim It has a firming action, strengthen and viscosity close to zero. solution viscosity close to zero. the sun and mitigate the effects of aging Refreshing of the skin of the legs Use/Claim Quelopatch Scar Reducer is specially designed Use/Claim Lesions: Barrier function sterile gauzes Main Indication Patch for a more efficient and safer exposition to Main Indication Fatigued legs: Patch that relieves swelling to help the scar to regain its function and preventing additional infection and improving UV rays and heaviness appearance go back to being normal skin. the healing process Unit Size 4 sachets (56 p.), 2 months treatment Unit Size 01 sachet 28 patches, 01 month treatment Main Indication Scars treatment Main Indication Sterile Gauze for breached skin Status Full develop Status Full develop Unit Size 1 sachet (2 p.) Unit Size Consumer unit of 20 sterile gauze in a twin Sold In (Countries) Iberia, Italy, Fr, Mx Sold In (Countries) Iberia, Italy, France Status Full develop sachet Sold In (Countries) Spain, Italy Status Full develop Sold In (Countries) Spain, Italy Product name IALUPATCH Product name PSORIPATCH Product name IALURAPID ZERO Vaginal Douche Product name IALURAPID ZERO Gel Category CE mark class 1 Category Cosmetic Category CE mark class 2a Category CE mark class 2a Ingredients Laluzero. Special Hyaluronic acid having a Ingredients UREA, ALOE VERA, IALUZERO® Ingredients Laluzero. Special Hyaluronic acid having a Ingredients Laluzero. Special Hyaluronic acid having a molecular weight lower than 50 KDa and solution (Hyaluronic Acid), Mangnesio Ascrobil fosfato molecular weight lower than 50 KDa and solution molecular weight lower than 50 KDa and viscosity close to zero. Use/Claim It is a patch of Hydro gel to treat the plaques viscosity close to zero. solution viscosity close to zero. Use/Claim Specially designed to help the skin to regain its of psoriasis and the scales Use/Claim Intimate cleansing: first aid solution for vaginal Use/Claim Provides hydration protection and hygiene functionality and appearance following the Main Indication Dry and scaling skin irritation and small lesions mucosa damaged or injured formation of a scar. Thanks to H.A. helps reduces 1 sachet (3 p.) Main Indication Intimate cleansing Main Indication Daily vaginal moisturizing gel Unit Size the time of the physiological healing process. Unit Size 3 uds. (30 ml.) Unit Size 1 unit (50ml) Status Full develop Main Indication Stretch mark Status Full develop Status Full develop Sold In (Countries) Spain, Italy Unit Size 1 sachet (2 p.) Sold In (Countries) Spain, Italy Sold In (Countries) Spain, Italy Status Full develop Sold In (Countries) Spain, Italy
  • 9. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME We are a flexible and innovative team, open to new ideas for future developments. Biogened We have high quality marketing and regulatory affairs management as well as a comprehensive sales network, enabling us to bring new ideas to market efficiently. Product name Protection of the Buccal Mucosa Product name VRR CITY Our production is compliant with GMP standards. Biogened as generic company is Category CE mark class 2a Category CE mark class 2a Lodz interested in buying licenses from CNS, oncology, Dermatology, Respiratory system, OTC - Cold. Ingredients Laluzero. Special Hyaluronic acid having a Ingredients Mechanical barrier, perfect occlusion of the COUNTRY Contact Preson: Karolina Lichanska (karolina.lichanska@biogened.pl) molecular weight lower than 50 KDa and solution zone affected by the wart. Poland Contact Telephone Number: 48 42 651 31 52 viscosity close to zero. Use/Claim Warts: Healing protection patch for barrier Use/Claim Palate and gums: mouthwash, gum gel, active effect and infection prevention PACK SHOTS sprays for irritation problems and small lesion in Main Indication Wart Patch, Topical application gums and palate Unit Size 4 sachets (48 patches) Main Indication To preserve the integrity of the oral mucous Status Full develop membrane Sold In (Countries) Spain, Italy Unit Size Fluid 250ml, Gel Tube 20ml Status Full develop Sold In (Countries) Spain, Italy OTC PRODUCTS Product name "Dermedic" dermocosmetics Product name "Ellexir" dermocosmetics Product name VNO PIKAN No mosquitoes patch Category OTC Category OTC Category General sale Ingredients Many active substances, without colorants, flavors, Ingredients Active substances: hialuronic acid, peptides ( Ingredients Citronella essential oils irritants, parabens a unique composition of technologically Use/Claim Self-adhesive strips saturated with resin- advanced active substances) Use/Claim Comprehensive taking care of the skin, stimulate embedded microcapsules on the outer patch its regeneration, increase resistance, delay aging Use/Claim Very exclusive series of dermocosmetics surface that gradually release the aromatic processes, reduction skin defects created for immediate delay of appearing the charge of their essential oils over time. Main Indication Problematic skin wrinkles Main Indication To keep mosquito’s away Unit Size 15g, 50g, 150g, 200g Main Indication Mimic wrinkles and physiological wrinkles Unit Size 01 consumer unit with 48 patches Status Available Unit Size 50g Status Full develop Sold In (Countries) Arabian countries, Nordic Countries, Slovakia Status Available Sold In (Countries) Launched in various EU markets Sold In (Countries) Portugal, Arabian countries, Nordic Countries, Czech Republic, U.S
  • 10. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME Bioxtract develops evidence based, natural food supplements, in unique and BioXtract proprietary formulations, offering improved bio availability and efficacy. We work business to business, offering finished products in bulk, ready for commercialisation by Product name “ProLady" supplements Product name "Rutimal" supplements CITY marketing partners worldwide. Category OTC Category OTC Louvain-la-Neuve Ingredients Red clover, Salvia, Melissa, Guarana, Yerba Ingredients Vitamins, Sage, Minerals, Rutoside, Garil, COUNTRY Contact Preson: Camilla Mackenzie (camilla.mackenzie@bioxtract.com) Mate, Acai, Aloe, Vitamins, Spiruline, Selenium Honey, lemon ,grapefruit juice Belgium Contact Telephone Number: +32-10-222870 Use/Claim etc. Use/Claim Lollypops for children and capsules for adults Main Indication For taking care of woman's health in states of decreased immunity PACK SHOTS Typical woman's problems Main Indication Sore throat, decreased immunity, loss of Unit Size 30 and 90 appetite," journey" problems Status Available Unit Size 10, 30 , 120 pack of lollypops and 30/90 Sold In (Countries) Arabian countries, Nordic Countries, Portugal capsules Status Available Sold In (Countries) Arabian countries, Nordic Countries, Portugal, Balkans OTC PRODUCTS Product name Arantal Product name Nasaler Category Food supplement Category Food supplement Ingredients Curcumin Ingredients Curcumin + quercetin Use/Claim A new formulation of highly bioavailable curcumin, Use/Claim A new formulation of highly bioavailable with efficacy on pain and inflammation curcumin, combined with quercetin to treat Main Indication Osteoarthritis symptoms of allergic rhinitis, having anthi- Soft gelatin capsules, supplied in bulk histamine and anti-inflammatory properties. Form EU Food supplement, TGA listing (Australia) Main Indication Allergic rhinitis Status Sold In (Countries) EU Form Soft gelatin capsules, supplied in bulk Status EU Food supplement, TGA listing (Australia) Sold In (Countries) EU
  • 11. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME Diapharm is a full-service provider for the healthcare industry. With about 100 Diapharm UK employees, Diapharm supports pharmaceutical companies in all questions concerning regulatory affairs, medical & clinical development, quality management and business Product name Cognityl Product name Regulid CITY development. Its activities focus on the sectors of medicinal products, food Category Food supplement Category Food supplement London / Munster supplements and dietetic food, medical devices and cosmetics. Diapharm is at the service of multinational companies as well as start-ups and mid-sized businesses. Ingredients Theobromine + caffeine Ingredients Vinyldithiins + sulfides COUNTRY Contact Preson: Karim Sultan (karim.sultan@diapharm.com) Use/Claim A product based on cocoa and tea extracts, with Use/Claim An innovative formulation of high Contact Telephone Number: +44 203 178 2790 UK / Germany Main Indication proven effect on focus, attention and mental performance garlic active principals, with a energy Mental alertness combined activity on cholesterol parameters PACK SHOTS Form Tablets, supplied in bulk involved in metabolic syndrome. Status EU Food supplement, TGA listing (Australia), Main Indication Metabolic syndrome Malaysian health supplement registration Form Liquid filled hard gelatin capsules, supplied in Sold In (Countries) EU, SE Asia bulk Status EU Food supplement, TGA listing (Australia), Malaysian health supplement registration Sold In (Countries) EU, SE Asia OTC PRODUCTS Product name Medicinal product (homeopathic) Product name Medicinal product (homeopathic) Category Medicinal product (homeopathic) Category Medicinal product (homeopathic) Ingredients Aesculus hippocastanum Dil D1, Arnica montana, Ingredients Drosera Dil. D4, Cephalis Ipecacuanha Dil. Silybum marianum Dil. D1, Hamamelis virginiana D6, Rumex crispus Dil. D4, Eriodictyon Dil. D1, Lachesis mutus Dil. D6, Lycopedium californicum Dil. D4, Echinacea clavatum Dil. D4, Melilotus officinalis Dil. D3 Use/Claim Cough and cold Varicosis Main Indication Homoeopathic medicinal product for intake Use/Claim Homoeopathic medicinal product for intake against against infects of the upper respiratory tract Main Indication varicose veins /varices Unit Size Mixture in amber bottle, 50 ml Mixture in amber bottle, 50 ml Status Marketing authorization Unit Size Marketing authorization Sold In (Countries) DE Status DE Sold In (Countries)
  • 12. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Artichoke leaf 400 mg Ingredients Artichoke leaf 400 mg Ingredients Chaste tree fruit 4 mg Ingredients Chaste tree fruit 4 mg Use/Claim Digestion & liver Use/Claim Digestion & liver Use/Claim Climacteric symptoms, menstrual disturbances Use/Claim Climacteric symptoms, menstrual disturbances Main Indication For dyspeptic complaints. Stimulates healthy bile Main Indication For dyspeptic complaints. Stimulates healthy Main Indication Well-established use: Irregularities of the Main Indication Well-established use: Irregularities of the production. This helps improve blood lipid levels. bile production. This helps improve blood lipid menstrual cycle, menstrual disturbances; tension menstrual cycle, menstrual disturbances; Unit Size Capsule levels. and swelling of the breasts (mastodynia); tension and swelling of the breasts Status Marketing authorization Unit Size Capsule premenstrual syndrome. - Traditional Use: (mastodynia); premenstrual syndrome. - Status Dossier Traditional herbal medicinal product used to help Traditional Use: Traditional herbal medicinal Sold In (Countries) UK relieve symptoms associated with premenstrual product used to help relieve symptoms Sold In (Countries) All European countries syndrome associated with premenstrual syndrome Unit Size Film-coated tablet Unit Size Film-coated tablet Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Status Marketing authorization Dossier Status Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Sold In (Countries) UK Sold In (Countries) All European countries Ingredients Black cohosh rhizome 6.5 mg Ingredients Black cohosh rhizome 6.5 mg Product name Medical Device Product name Medicinal product (WEU/THMP) Use/Claim Climacteric symptoms, menstrual disturbances Use/Claim Climacteric symptoms, menstrual disturbances Category Medical device Category Medicinal product (WEU/THMP) Main Indication Well-established use: For improvement of climacteric (menopausal) symptoms and Main Indication Well-established use: For improvement of Ingredients Chitosan 500 mg Ingredients Devil´s claw root 600 mg dysmenorrhoeic neurovegetative disorders. - climacteric (menopausal) symptoms and Use/Claim Treatment of elevated blood lipid levels (Weight Use/Claim Aches Traditional Use: Traditional herbal medicinal dysmenorrhoeic neurovegetative disorders. - control) Main Indication Traditional Use: Traditional herbal medicinal product used to relieve the symptoms of the Traditional Use: Traditional herbal medicinal Main Indication Binding of nutritional fat in order to support the product used for the relief of backache, menopause, such as hot flushes, night sweats product used to relieve the symptoms of the treatment of overweight people on a fat reduced rheumatic or muscular pain, and general and temporary changes in mood. menopause, such as hot flushes, night diet, maintenance of bodyweight within a fat aches and pain in the muscles and joints - Unit Size Film-coated tablet sweats and temporary changes in mood. conscious diet, reduction of cholesterol intake HMPC monograph: Traditional HMP for relief Marketing authorization Unit Size Film-coated tablet Unit Size Tablet of minor articular pain Status Sold In (Countries) UK Status Dossier Status CE mark Unit Size Film-coated tablet Sold In (Countries) All European countries Sold In (Countries) All European countries Status Marketing authorization Sold In (Countries) UK
  • 13. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Devil´s claw root 600 mg Ingredients Feverfew herb 100 mg Ingredients Hawthorn leaf and flower 450 mg Ingredients Hawthorn leaf and flower 300 mg Use/Claim Aches Use/Claim Aches and migraine Use/Claim Mild cardiac insufficiency Use/Claim Mild cardiac insufficiency Main Indication Traditional Use: Traditional herbal medicinal Main Indication Traditional herbal medicinal product used for Main Indication Mild cardiac insufficiency, senile heart. Main Indication Mild cardiac insufficiency, senile heart. product used for the relief of backache, the prevention of migraine headaches, based Unit Size Film-coated tablet Unit Size Coated tablet rheumatic or muscular pain, and general aches on traditional use only Status Dossier Status Marketing authorization and pain in the muscles and joints - HMPC Unit Size Capsule Sold In (Countries) All European countries Sold In (Countries) DE monograph: Traditional HMP for relief of minor Status Marketing authorization articular pain Sold In (Countries) UK Unit Size Film-coated tablet Status Dossier Sold In (Countries) All European countries Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Devil´s claw root 600 mg Ingredients Feverfew herb 100 mg Ingredients Hawthorn leaf and flower 300 mg Ingredients Hawthorn leaf and flower 40 mg, Potassium Use/Claim Aches Use/Claim Aches and migraine Use/Claim Mild cardiac insufficiency aspartat 150 mg, Magnesium aspartat 150 mg Main Indication Traditional Use: Traditional herbal medicinal Main Indication Traditional herbal medicinal product used for Main Indication Mild cardiac insufficiency, senile heart. Use/Claim Mild cardiac insufficiency product used for the relief of backache, rheumatic the prevention of migraine headaches, based Unit Size Coated tablet Main Indication A traditional herbal medicinal product used for or muscular pain, and general aches and pain in on traditional use only Status Dossier the relief of mild cardiac injuries (senile heart), the muscles and joints - HMPC monograph: Unit Size Capsule based on traditional use only Sold In (Countries) All European countries Traditional HMP for relief of minor articular pain Status Dossier Unit Size Coated tablet Unit Size Film-coated tablet Sold In (Countries) All European Countries Status Dossier Status Dossier Sold In (Countries) All European countries Sold In (Countries) All European countries
  • 14. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Medical device Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medical device Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Lactobacillus-johnsonii EU1 4x10^5 - 4x10^7 Ingredients Milk Thistle fruit 177.4 - 240.4 mg, corresp. to Ingredients Passionflower herb 250 mg, Valerian root 125 mg Ingredients Passionflower herb 250 mg, CFU/cap. 108.2 mg Silymarin Use/Claim Mild nervous tension, sleep disorder Valerian root 125 mg Use/Claim Treatment of gastro-intestinal disorders Use/Claim Digestion & liver Main Indication Well-established Use: For the relief of mild Use/Claim Mild nervous tension, sleep disorder Main Indication Treatment and prophylaxis of non-specific Main Indication Supportive treatment of chronic-inflammable nervous tension and difficulty in falling asleep. - Main Indication Well-established Use: For the relief of mild diarrhea,Treatment and prevention of liver injuries, cirrhosis of the liver and toxic Traditional Use: Traditional herbal medicinal nervous tension and difficulty in falling recurrences of antibiotic-induced diarrhea liver injuries (caused by hepatotoxic agents) product used for the temporary relief of sleep asleep. - Traditional Use: Traditional herbal Unit Size Opaque hard capsule, size 1 Unit Size Capsule disturbances due to symptoms of mild anxiety. medicinal product used for the temporary Status CE mark Status Dossier Unit Size Coated tablet relief of sleep disturbances due to symptoms Status Marketing authorisation of mild anxiety. Sold In (Countries) All European countries Sold In (Countries) All European countries Sold In (Countries) UK, PL Unit Size Coated tablet Status Dossier Sold In (Countries) All European countries Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Ingredients Nettle root 460 mg Ingredients Passionflower herb 425 mg Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Use/Claim Prostate Use/Claim Mild nervous tension, sleep disorder Ingredients Pelargonium root 20 mg Ingredients Plantain herb 300 mg Main Indication Traditional herbal medicinal product used to Main Indication Well-established Use: For the relief of mild Use/Claim Cough and cold Use/Claim Cough and cold relieve urinary discomfort in men with an nervous tension. - Traditional Use: Traditional Main Indication Traditional herbal medicinal product for the relief Main Indication Catarrh of the respiratory tract, inflammations enlarged prostate (BPH). herbal medicinal product for relief of mild of symptoms of upper respiratory tract infections of the oral and pharyngeal mucosa. Unit Size Film-coated tablet symptoms of mental stress and to aid sleep. including common cold, such as sore throat, Unit Size Effervescent tablet Dossier Unit Size Coated tablet cough and blocked or runny nose. Status Marketing authorization Status Sold In (Countries) All European countries Status Dossier Unit Size Film-coated tablet Sold In (Countries) DE Sold In (Countries) All European countries Status Dossier Sold In (Countries) All European countries
  • 15. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Plantain herb 300 mg Ingredients Red vine leaf 180 mg Ingredients St. John´s Wort herb 250 mg Ingredients St. John´s Wort herb 425 mg Use/Claim Cough and cold Use/Claim Circulatory function Use/Claim Low mood Use/Claim Low mood Main Indication Catarrh of the respiratory tract, inflammations of Main Indication Symptomatic relief of venous relief to help Main Indication Well-established use: Psychovegetative Main Indication Well-established use: Psychovegetative the oral and pharyngeal mucosa. maintain healthy leg vein circulation. disorders, mild depressive moods. - Traditional disorders, mild depressive moods. - Unit Size Effervescent tablet Unit Size Capsule Use: Traditional herbal medicinal product used to Traditional Use: Traditional herbal medicinal Status Dossier Status Dossier relieve the symptoms of slightly low mood and product used to relieve the symptoms of Sold In (Countries) All European countries mild anxiety. slightly low mood and mild anxiety. Sold In (Countries) All European countries Unit Size Film-coated tablet Unit Size Coated tablet Status Dossier Status Dossier Sold In (Countries) All European countries Sold In (Countries) All European countries Product name Medicinal product (WEU/THMP) Product name Medical Device Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medical device Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Siberian ginseng root 120 mg Ingredients Simethicon 125mg Ingredients St. John´s Wort herb 300 mg, Black cohosh Ingredients St. John´s Wort herb 120 mg, Use/Claim rhizome 6.4 mg Valerian root 56 mg Use/Claim Convalescence Use/Claim Treatment of gastro-intestinal disorders Main Indication Climacteric symptoms, menstrual disturbances Use/Claim Low mood Main Indication Traditional herbal medicinal product for symptoms Main Indication De-foaming agent for the symptomatic of asthenia such as fatigue and weakness, treatment of flatulence and gastrointestinal Traditional herbal medicinal product for the relief Main Indication Traditional herbal medicinal product for the exclusively based upon long-standing use complaints, e.g. Meteorism of neurovegetative disorders and low mood in relief of slightly low mood and mild anxiety, connection with menopausal symptoms, sleep disturbances due to symptoms of mild Unit Size Capsule Unit Size Chewable Soft Gelatin Capsule exclusively based upon long-standing use. anxiety, exclusively based upon long-standing Status Dossier Status CE mark use. Unit Size Coated tablet Sold In (Countries) All European countries Sold In (Countries) All European countries (except UK, IRE) Status Dossier Unit Size Coated tablet Sold In (Countries) All European countries Status Dossier Sold In (Countries) All European countries
  • 16. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Medicinal product (WEU/THMP)Medicinal Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Valerian root 150 mg Ingredients Valerian root 150 mg Ingredients Valerian root 450 mg Ingredients Valerian root 425 mg, Melissa leaf 220 mg Use/Claim Mild nervous tension, sleep disorder Use/Claim Mild nervous tension, sleep disorder Use/Claim Mild nervous tension, sleep disorder Use/Claim Mild nervous tension, sleep disorder Main Indication Herbal medicinal product for the relief of mild Main Indication Herbal medicinal product for the relief of mild Main Indication Well-established Use: Herbal medicinal product Main Indication For the relief of mild nervous tension and nervous tension and sleep disorders. (also for nervous tension and sleep disorders. (Also for the relief of mild nervous tension and sleep difficulty in falling asleep. children over 6 years old) for children over 6 years old) disorders. Unit Size Coated tablet Unit Size Coated tablet Unit Size Coated tablet Unit Size Coated tablet Status Marketing authorization Status Marketing authorization Status Dossier Status Dossier Sold In (Countries) DE Sold In (Countries) DE, UK, PL, PT Sold In (Countries) All European countries Sold In (Countries) All European countries Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Valerian root 300 mg Ingredients Valerian root 300 mg Ingredients Valerian root 425 mg, Melissa leaf 220 mg Ingredients Valerian root 125 mg, Melissa leaf 112.5 mg, Use/Claim Mild nervous tension, sleep disorder Passionflower herb Use/Claim Mild nervous tension, sleep disorder Use/Claim Mild nervous tension, sleep disorder Main Indication For the relief of mild nervous tension and Use/Claim Mild nervous tension, sleep disorder Main Indication Herbal medicinal product for the relief of mild Main Indication Herbal medicinal product for the relief of mild nervous tension and sleep disorders. (Also for nervous tension and sleep disorders. (Also difficulty in falling asleep. Main Indication For the relief of mild nervous tension and children over 6 years old) for children over 6 years old) Unit Size Coated tablet difficulty in falling asleep. Unit Size Coated tablet Unit Size Coated tablet Status Dossier Unit Size Coated tablet Status Marketing authorization Status Dossier Sold In (Countries) All European countries Status Marketing authorization Sold In (Countries) DE Sold In (Countries) All European countries Sold In (Countries) UK, AT
  • 17. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME EMS is the leader of the pharmaceutical market in Brazil, both in revenue and in units EMS - even considering all the multinationals. It has two GMP production sites in Sao Paulo, where operates a modern industrial complex, including one of the largest R&D centers. CITY The drugs are distributed in Brazil and in our subsidiaries, in Italy, Portugal and Spain, Name Acetylcysteine Name Carbocysteine Sao Paulo and exported to more than 30 countries. Form Granulated Powder (Sachet) Form Syrup & Suspension Strength 200mg, 600mg Strength 20mg/Ml (Pediatric) 50mg/Ml COUNTRY Contact Preson: José Piccolotto (jose.piccolotto@ems.com.br) Contact Telephone Number: 55 - 19 - 3887.9934 Indication Expectorants Indication Mucolytics Brazil Status Anvisa/Br Status Anvisa/Br PACK SHOTS Name Clobutinol Hydrochloride Name Ketoconazole Form Syrup Form Shampoo Strength 4mg/Ml Strength 20mg/G Indication Cough Suppressants Indication Topical Scalp Antifungals Status Anvisa/Br Status Anvisa/Br OTC PRODUCTS Name Bromhexin Hydrochloride Name Naphazoline Hydrochloride Name Ambroxol Hydrochloride Name Terbinafine Hydrochloride Form Syrup Pediatric Form Nasal Solution Form Syrup Pediatric Without Sugar Form Cream Strength 4mg/5ml Strength 0,50mg/Ml Strength 3mg/Ml Strength 10mg/G Indication Mucolytics Indication Nasal Decongestants Indication Expectorants Indication Topical Dermatological Antifungals Status Anvisa/Br Status Anvisa/Br Status Ctd-Eu Status Ctd-Eu Name Acetylsalicylic Acid Name Aceclofenac Name Neomycin Sulfate + Bacitracin Name Diclofenac Diethylammonium Form 100mg, 300mg, 500mg Form Cream Form Ointment Form Gel Strength Tablet (+Fc) Strength 15mg/G Strength 5mg/G + 250 Ui/G Strength 10mg/G Indication Analgesics And Antipyretics Indication Anti-Inflammatories Indication Antibacterials Topics Indication Anti-Inflammatories Status Anvisa/Br Status Anvisa/Br Status Anvisa/Br Status Anvisa/Br
  • 18. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Name Diclofenac Sodium Name Dimethicone Name Aluminum Hydroxide Name Dexchlorpheniramine Maleate Form Gel Form Drops Form Oral Suspension Form Cream Strength 10mg/G Strength 75mg/Ml Strength 61,5mg/Ml Strength 10mg/G Indication Anti-Inflammatories Indication Antiflatulents Indication Antacids Indication Antihistamines Status Anvisa/Br Status Anvisa/Br Status Anvisa/Br Status Anvisa/Br Name Dimethicone + Homatropine Methylbromide Name Dimethicone Name Mebendazole Name Nimesulide Form Drops Form Capsule / Tablet Form Tablet & Oral Suspension Form Gel Strength 80 + 2,5mg/Ml Strength 125mg / 40mg Strength 100mg & 20mg/Ml Strength 20mg/G Indication Antiflatulents And Anticholinergics Indication Antiflatulents Indication Benzimidazole Derivatives Indication Anti-Inflammatories And Antirheumatics Status Anvisa/Br Status Anvisa/Br Status Anvisa/Br Status Anvisa/Br Name Dipyrone Sodium Name Dipyrone Sodium + Isometheptene + Caffeine Name Nystatin + Zinc Oxide Name Miconazole Nitrate Form Drops & Oral Solution & Tablet Form Drops Form Ointment Form Cream & Lotion Strength 500mg/Ml Strength 300 + 50 + 30mg/Ml Strength 100.000 Ui/G + 200mg/G Strength 20mg/G & 20mg/Ml Indication Analgesics And Antipyretics Indication Functional Bowel Disorders Indication Wound-Healing Agents Indication Plain Topical Corticosteroids Status Anvisa/Br Status Anvisa/Br Status Anvisa/Br Status Anvisa/Br Name Dipyrone Sodium + Scopolamine Name Guaifenesin Name Tiabendazole Name Apevitin Bc Hydrobromide Form Syrup (Honey) Form Ointment Form Syrup Form Oral Solution Strength 200mg/12,5ml Strength 50mg/G Strength Thiamine Hydrochloride + Riboflavin + Strength 6,67 + 333,4mg/Ml Indication Expectorants Indication Antihelminthics Pyridoxine Hydrochloride + Nicotinamide + Indication Analgesics And Antiemetics Status Anvisa/Br Status Anvisa/Br Ascorbic Acid Status Anvisa/Br Indication Appetite Stimulants Status Anvisa/Br
  • 19. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME Farmalider, S.A. is a private company of Madrid, Spain, specialized in the development Diapharm UK and licensing out of products in the following areas: OTC - including food supplements with a medical claim Name Cystex Name Complexo B CITY Value-added - new presentations and combinations Form Coated Tablet Form Syrup & Tablet & Drops Madrid Innovative - registered as novelty products with preferred pricing Branded Generics - specific to individual market requirements Strength Acriflavine Hydrochloride + Methenamine + Strength Thiamine Hydrochloride + Riboflavin + COUNTRY Contact Preson: Susanna El-Armale (susannna.elarmale@farmalider.com) Methylthioninium Chloride + Belladonna Powder Pyridoxine Hydrochloride + Cyanocobalamin Spain Contact Telephone Number: +34 93 447 39 58 15 + 250 + 20 + 15mg + Nicotinamide + Calcium Pantothenate Indication Antiseptics, Urinary (3mg + 1mg + 1mg + 1,5mcg + 2,5mg + 1,5mg)/Ml PACK SHOTS Status Anvisa/Br Indication Multivitamins Status Anvisa/Br Name Gripen F Name Stilux Form Capsule Form Ophthalmic Solution OTC PRODUCTS Strength Paracetamol + Phenylephrine Hydrochloride + Strength Zinc Sulfate + Naphazoline Hydrochloride + Chlorpheniramine Boric Acid + Sodium Borate Product Name BENZOCAINE Product Name BENZOCAINE/ TETRACAINE 400 + 4 + 4 Mg 0,15 + 0,30 + 15 + 0,70mg/Ml Strength 5% Strength 14%/ 2% Indication Analgesics, Descongestants And Antihistamines Indication Ophtalmic Aseptic Adstringent Presentation Gel Presentation Spray Status Anvisa/Br Status Anvisa/Br Use/Claim Toothache relief Use/Claim Toothache relief Status 2011 Status Q2 2011 Product Name BIPxine®/ ALOE VERA/ ROSE RUBIGINOSA Product Name BIPxine®/ ALOE VERA/ ROSE Strength N/A Strength RUBIGINOSA/CENTELLA ASIATICA Presentation Cream Presentation N/A Use/Claim Repair cream post-laser in large areas Use/Claim Cream (legs, back) Repair cream post-laser in sensitive areas Status Available (armpits, bikini area, face) Status Available
  • 20. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product Name CHLORHEXIDINE/ BENZOCAINE Product Name DEXTROMETHORPHAN HBr Product Name FOLIC ACID/ IODINE/ VITAMIN B12 Product Name FOLIC ACID/ IODINE/ VITAMIN B12/ IRON Strength 5 mg/ 2 mg Strength 10 mg/5 ml Strength 400 mg/ 294 mg/ 2 mg Strength 400 mg/ 294 mg/ 2 mg Presentation Lozenges Presentation Oral solution (multidose bottles) Presentation Tablets Presentation Tablets Use/Claim Oral antiseptic Use/Claim Cough relief Use/Claim Indicated for the prevention of deficiency Use/Claim Products formulated to meet nutritional needs Status Q4 2010 Status Available disorders in pregnant women Status in pregnant women or those trying to get Status Available pregnant. Prophylaxis of neural tube defects, prevention of neurological disorders in the fetus and preventing anemia caused by iron deficiency Q42010 Product Name DEXTROMETHORPHAN HBr Product Name DEXTROMETHORPHAN HBr Strength 15 mg Strength 10 mg Product Name HYALURONIC ACID/ HORSE-CHESTNUT/ Product Name IBUPROFEN Presentation Soft-gel capsules Presentation Lozenges CAFFEINE/ MENTHOL Strength 200 mg, 400 mg, 600 mg Use/Claim Cough relief Use/Claim Cough relief Strength N/A Presentation Tablets Status Q42010 Status Q32010 Presentation Crackling gel Use/Claim Analgesic, antipyretic, anti-inflammatory Use/Claim Relief for heavy and tired legs Status Available Status Available Product Name DEXTROMETHORPHAN HBr Product Name ELEUTEROCOCCUS/ MINERALS/ VITAMINS Product Name IBUPROFEN (2%) Product Name IBUPROFEN (4%) Strength 5 mg/ml, 10 mg/5 ml Strength N/A Strength 20 mg/ml Strength 40 mg/ml Presentation Oral solution (unidose sticks) Presentation Capsules Presentation Oral suspension (multidose bottles) Presentation Oral suspension (multidose bottles) Use/Claim Cough relief Use/Claim Vitamin and mineral supplement for women Use/Claim Analgesic, antipyretic (paediatric) Use/Claim Analgesic, antipyretic (paediatric) Status Q32010 taking the contraceptive pill Status Available Status Available Status Available
  • 21. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product Name IBUPROFEN Product Name IBUPROFEN (arginine) Product Name PARACETAMOL Product Name PARACETAMOL/ PSEUDOEPHEDRINE Strength 100 mg, 200mg, 400mg, 600mg Strength 200mg, 400mg, 600mg Strength 500 mg, 650 mg, 1g SULPHATE/ DEXTROMETHORPHAN Hbr Presentation Oral suspension Presentation Granules for oral solution (unidose sachets) Presentation Tablets Strength 500 mg/ 30 mg/ 15 mg Use/Claim Analgesic, antipyretic, anti-inflammatory Use/Claim Analgesic, antipyretic, anti-inflammatory Use/Claim Analgesic, antipyretic Presentation Powder for oral solution (unidose sticks) Status Available Status Available Status Available Use/Claim Cough and cold Status Available Product Name IBUPROFEN Product Name LIGNANS/ RESVERATROL/ GREEN TEA/ Product Name VITAMINS / MINERALS/ OMEGA-3/ OMEGA-6 Strength 200 mg, 400mg RED CLOVER/ MINERALS/ VITAMINS Strength N/A Presentation Orodispersible powder Strength N/A Presentation Capsules Use/Claim Antipyretic and pain mild to moderate Presentation Capsules Use/Claim Indicated to meet the nutritional needs of a Status Q22011 Use/Claim Relief of climacteric symptoms for women in mother during breastfeeding period menopause Status Available Status Available Product Name LORATADINE Product Name PARACETAMOL Strength 10 mg Strength 250 mg, 325 mg, 500mg Presentation Soft – gel capsules Presentation Orodispersable granules (unidose sticks) Use/Claim Antihistamine Use/Claim Analgesic, antipyretic (paediatric) Status Available Status Available
  • 22. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME Helvetia Pharma is a Czech - Swiss company established in 2005 and focused on Helvetia Pharma research, development, manufacturing and marketing of immunostimulants and dietary supplements. We manufacture our own private label products under our manufacturing CITY arm, using the latest technologies. Our factory holds EU GMP certification. VaxinHP Product name RespiVaxin HP Product name DentalVaxin HP and DentalVaxin HP Kids Prague products are intended for prevention and treatment of most common diseases using Category Dietary Supplement Category Dietary Supplement microbial immunomodulators. Ingredients *Streptococcus Pneumonia, *Klebsiella Ingredients *Streptococcus Mutans, *Streptococcus COUNTRY Contact Preson: Mona Sandescu (info@helvetiapharma.cz) Pneumoniae, *Staphylococcus Aureus, Sanguis, *Streptococcus Mitis, *Actinomyces Czech Rebublic Contact Telephone Number: 00 420 222 511 878 *Streptococcus Pyogenes, *Escherichia Coli, Viscosus, *Erythritol, *Coenzime Q10, *Bovinní Kolostrum, *Beta Glucan *Manitol PACK SHOTS Use/Claim *Suitable for everybody with recurrent Use/Claim *Treatment and prevention of dental caries, respiratory system inflammation caused by *Improves condition of mouth mucosa, bacteria, *Improves respiratory mucosa *Strong non specific immunomodulatory conditions, *Represents the most common effect, *Product for adults, *Product for kids bacteria which cause respiratory infections (6+ years) Main Indication ORL Main Indication Stomatology OTC PRODUCTS Unit Size 30 capsules Unit Size 30 capsules Product name FemiVaxinum NEO Product name NefroVaxin HP Status Approved Status Approved Category Dietary Supplement Category Dietary Supplement Sold In (Countries) Czech Republic, Slovakia Sold In (Countries) Czech Republic, Slovakia, Ingredients *Candida Albicans *Candida Glabrata, *Candida Ingredients *Klebsiella Pneumonia,*Pseudomonas Krusei, *Gardnerella Vaginalis, *Candida Aeruginosa, *Enterococcus Faecalis, Tropicalis, *Propionibacterium Acnes Lysatum, *Escherichia coli, *Proteus Mirabilis, *Beta Glucan *Propionibacterium Acnes Lysatum, *Beta Glucan Use/Claim *Suitable for women with recurrent vaginal Use/Claim *Suitable for women and men with recurrent inflammation caused by yeasts or bacteria, urinary system inflammation caused by bacteria, *Improvement of vaginal mucosa conditions *Improves urinary system conditions, *Addition Main Indication Gynecology agent to the decreased immunity treatment Unit Size 30 capsules Main Indication Urology Status Approved Unit Size 30 capsules Sold In (Countries) Czech Republic, Slovakia, Azerbaijan, Poland Status Approved Sold In (Countries) Czech Republic, Slovakia, Azerbaijan, Poland
  • 23. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY PROFILE COMPANY NAME Oystershell is a specialized developer of over-the counter health products. Since COMPANY NAME Progressare Medinvest is a group of companies that offer innovative product Oystershell several years the company has been dedicated to the research and development of Progressare development in a healthcare industry. Progressare offers innovative product low risk and soft claim health products such as dietary supplements and medical technologies with a focus on medical devices. Our focus is aimed at establishing niche CITY devices. This strategy has led to the international launch of several new-generation CITY markets in which we launch new brands to extend the complete product categories Drongen products in OTC sub domains such as head lice treatment, oral care, burns Amsterdam rather than compete with existing products.All our products are patented, validated, management and others. clinically evaluated,registered and licensed. COUNTRY Contact Preson: André Janssens (andre.janssens@oystershell.com) COUNTRY Contact Preson: Maikel Hendriks (m.hendriks@progressare.com) Belgium Contact Telephone Number: 32 9 377 24 85 Netherlands Contact Telephone Number: +31 (0)20 345 95 05 PACK SHOTS PACK SHOTS OTC PRODUCTS OTC PRODUCTS Product name Flamozil Product name Tixozin Product name Dry Mouth Spray Product name Bladder Infection Capsule Category OTC Category OTC Category Medical Device Category Medical Device Ingredients Carbomere Ingredients Zinc oxide Ingredients Patented Rye Extract Ingredients Patented Rye Extract Use/Claim Paraben-free hydrogel spray for wound Use/Claim Prevention of diaper rash Use/Claim Treats symptoms of Xerostomia, Treats fungus Use/Claim Treats and prevents bladder infection. Helps treatment Main Indication Prevention of diaper rash infections, Treats and prevents gingivitis and bad the bladder clean. Increases the resistance in Main Indication Superficial burns, grazed skin, bedsores, Unit Size Pump spray 100ml breath. Balances mouth flora. For moderate to the bladder. Good for urinary tract. Has a open leg sores severe Dry Mouth; Long lasting relief; beneficial effect on the acidity of urine. Works Status Medical device Unit Size Spray can 50g – Spray can 75g - Spray can Status Class I preventatively during stress or other Sold In (Countries) TBD 285g - Tube 50g Sold In (Countries) Nordics medication Status Medical device Status Class Iia Sold In (Countries) TBD Sold In (Countries) The Nederlands
  • 24. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Cold Sore Prevention Product name Fissure Wipes Product name Wart Pen Product name Wound Healing Spray Category Medical Device Category Medical Device Category Medical Device Category Medical Device Ingredients Zinc Particles Ingredients 100% natural extracts of witch hazel, Sweet Ingredients Patented Rye Extract Ingredients Patented Rye Extract Use/Claim Treats and prevents the symptoms of cold sores. Use/Claim broom, horse-chestnut and vitamins. Use/Claim Painless treatment and removal of warts and Use/Claim For external treatment of small cuts, burns Relieve dryness and flaking. Revitalizing to Treat and provide relief from hemorrhoidal corns. and insect bites. Aids in the natural healing support natural healing. irritation.Cooling sensation and soothing Status Class IIa process. Revitalizing to support natural Status Class I effect to calm inflamed tissues immediately Sold In (Countries) Most European Markets healing. Prevent scarring. Stimulates skin Sold In (Countries) The Nederlands upon contact. Temporary relief of irritation regeneration. Provides soothing effect on and burning. Effective astringent and contact. Prevents bacterial infections. antiseptic medical properties to accelerate Relieves pain and discomfort (infection risks). the anal skin healing process. Status Class IIa Status Class I Sold In (Countries) The Nederlands Sold In (Countries) The Nederlands, UK Product name Vaginal Capsule Product name Nail Fungus Pen Category Medical Device Category Medical Device Ingredients Patented Rye Extract Ingredients Patented Rye Extract Use/Claim Prevents and treats Bacterial Vaginosis (BV); Use/Claim Treats and prevents nail fungus. Revitalizes Reduces unpleasant odor and discharge; your damaged nails. Fast results. Optimizes the vaginal flora and condition of the Status Class IIa tissues. Counters yeast. Sold In (Countries) Most European Markets Status Class IIa Sold In (Countries) The Nederlands
  • 25. OTC & Biosimilar Directory Supplement FEATURED COMPANY: Intas COMPANY PROFILE OTC & Biosimilar Directory Supplement COMPANY NAME IBPL is an integrated biopharmaceutical company with in house facility for Intas development, manufacturing of bulk and finished formulation. GMP certifications from BIOSIMILAR COMPANY LIST CITY Ahmedabad Europe, South-Africa, and GCC. Peg GCSF, GCSF, EPO and IFN and seven more biosimilar molecules under development. Celestial Biological, a subsidiary of IBPL is actively engaged in marketing of plasma proteins – Albumin and IVIG under the brand ‘Albucel’,‘Globucel’ and factocel in India. FEATURED COMPANY Contact Preson: Dr. Subir Basak (subir.basak@intasbiopharma.co.in) COUNTRY Intas India Contact Telephone Number: 00-917966112501 PACK SHOTS 3S Bharat Biotech Bioton Emcure BIOSIMILAR PRODUCTS Interlong Product name Main Indication Unit Size Status Sold In (Countries) MJ Biopharm NEUKINE (GCSF) Febrile Neutropenia 150 mcg/1 ml,300 mcg/1 Commercial SE Asia, LATAM, ml,480 mcg /0.5 ml MENA, CIS-Russia. Pharmaclon available in PFS Under registration in US and Europe Reliance ERYKINE(rHu EPO) Chronic renal failure 2000 iu,4000 iu,10000iu, Commercial SE Asia, LATAM, Shantha Anemia associated 40000 iu/1 mlvailable in MENA, CIS-Russia with Cancer PFS Shreya INTALFA(rHu IFN Alfa 2b) Hepatitis B&C, 3 miu, 5 miu /1 ml Commercial SE Asia, LATAM, Multiple myeloma available inb PFS MENA, CIS-Russia NEUPEG / PEGASTA(rHu Peg GCSF) Febrile Neutropenia 6 mg/1 ml & 6 mg /0.6 ml Commercial SE Asia, LATAM, available in PFS MENA, CIS-Russia
  • 26. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME Shenyang Sunshine Pharmaceutical Company Limited (SUNSHINE) is an integrated 3S biopharmaceutical company engaged in research/development, manufacture and marketing/sales of biopharmaceutical products in China. Our recombinant, or CITY genetically engineered, protein-based products and product candidates are designed Product name Main Indication Unit Size Status Sold In (Countries) Shenyang to address large markets with significant unmet medical needs in nephrology, oncology, ALBUCEL(Human albumin) Restores blood volume 20g/100 ml Commercial India supportive cancer care, inflammation and infectious disease. COUNTRY Contact Preson: Dr. Yingfei Wei (yingfeiwei@3sbio.com) FACTOCEL (Factor VIII) For the treatment of 250 iu /vial Commercial India China Contact Telephone Number: +86 24 2538 6060 Haemophlia PACK SHOTS GLOBUCEL Primary immunodeficiency, 5gm/100 ml Commercial India (Human immunoglobulin G) Kawasaki syndrome, Idiopathic thrombocytopenic purpura, B-cell chronic lymphocytic leukemia, Allogenic bonemarrow transplantation, CIPD, Gullaine barre syndrome, Paediatric HIV1 Infection BIOSIMILAR PRODUCTS Peg IFN Dev. Phase Product name Main Indication Unit Size Status Sold In (Countries) Recombinant Human Erythropoietin Injection Anemia associated with 2000IU/vial, 3000IU/vial, Approved China PTH Dev. Phase renal failure 4000IU/vial, 10000IU/vial FSH Dev. Phase Recombinant Human Thrombopoietin Injection Thrombocytopenia 7500U/1ml , 15000U/1ml Approved China Etanercept Dev. Phase Recombinant Interferon ·-2a Lymphatic or haemopoietic 1MIU, 3MIU, 5MIU Approved China tumor. Hepatitis B & C Rituximab Dev. Phase Recombinant Human Interleukin-2 Metastatic renal cell 100,000 200,000 500,000, Approved China Bevacizumab Dev. Phase carcinoma 1M IU Heparin Sodium Anticoagulant 1000, 5000 and 25000 IU Approved China
  • 27. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY PROFILE COMPANY NAME Bharat Biotech, Hyderabad, India, is a multidimensional biotechnology company COMPANY NAME BIOTON S.A., a biotechnology company, produces recombined human insulin and Bharat Biotech specialising in product-oriented research, development and manufacturing of vaccines Bioton other protein substances based on gene recombination and protein processing and biotherapeutics; established in the year 1996. BBIL's state-of-the-art techniques. It produces drug pharmaceutical forms for injections, including CITY manufacturing plant is the largest of its kind in Asia-Pacific. Built with an investment of CITY biotechnological drugs. The company sells its products primarily in Russia, Belarus, Hyderabad over INR 1000 million, the Manufacturing, Control Procedures and Protocols, conform Warsaw Lithuania, Georgia, Azerbaijan, Ukraine, and Vietnam. BIOTON was founded in 1989 to the internationally recognized institutions such as USFDA, UKMCA and WHO. and is based in Warsaw, Poland. COUNTRY Contact Preson: Mr Sai Prasad (prasadsd@bharatbiotech.com) COUNTRY Contact Preson: Radosaw Romanczuk (romanczukr@bioton.pl) India Contact Telephone Number: +91 40 2348 0567 Poland Contact Telephone Number: 48 (22) 721 40 00 PACK SHOTS PACK SHOTS BIOSIMILAR PRODUCTS BIOSIMILAR PRODUCTS Product name Main Indication Unit Size Status Sold In (Countries) Product name Main Indication Unit Size Status Sold In (Countries) Recombinant Hepatitis-B Vaccine Hepatitis-B 10mcg, 20mcg Approved India Somatropin rDNA origin Hormone 5mg Approved EU Regular Insulin Injection Soluble EP , Biosynthetic, Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved Poland Vi Capsular polysaccharide of Salmonella Typhoid fever 25 μg / 0.5ml Approved India dervived by Human rDNA Technology typhi (Ty2 strain) Insulin Injection, Isophane EP , Biosynthetic, derived by Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved Poland Recombinant Human Epidermal Growth Diabetic Foot Ulcers 150 μg / gm Approved India Human rDNA Technology Factor Gel Mixture of Insulin Injection Soluble (10%) and Insulin Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved Poland Injection Isophane (90%) , Biosynthetic, derived by Enoxaparin Anti-thrombotic 20mg, 40mg, 60mg Approved India Human rDNA Technology Mixture of IIS (20%) and III (80%) Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved Poland Heparin Sodium Anticoagulant 1000, 5000 and 25000 IU Approved India Mixture of IIS (30%) and III (70%) Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved Poland Mixture of IIS (40%) and III (60%) Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved Poland Mixture of IIS (50%) and III (50%) Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved Poland
  • 28. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY PROFILE COMPANY NAME Established in 1983, Emcure has a commitment and drive, propelled growth from a COMPANY NAME Shenzhen Neptunus Interlong Bio-Technique Co, a hi-tech enterprise, covers research Emcure single manufacturing facility , to a range of world class manufacturing facilities spread Interlong and development, production, sales and distribution. Due to many years of excellent across API, formulations and biotechnology. In 2006, it received US FDA approval for management, it keeps its leading status in domestic market and pursues the strategy CITY its solid dosages facility at Hinjwadi, Pune. With this approval, the facility has CITY of internationalization. Gujarat accreditation from US FDA, UK MHRA, WHO Geneva and MCC South Africa. Shenzhen COUNTRY Contact Preson: Ramesh Souri (ramesh.souri@emcure.co.in) COUNTRY Contact Preson: Zhang Simin (contact@interlong.com) India Contact Telephone Number: 91 20-30610000 China Contact Telephone Number: 86 755 26411869 BIOSIMILAR PRODUCTS PACK SHOTS Product name Main Indication Unit Size Status Sold In (Countries) Filgrastim Allergens 150 mcg, 300 mcg Approved India Recombinant Human Granulocyte Allergens 250 mcg, 300 mcg Approved India Macrophage Colony Stimulating factor (r-hu-GMCSF) R Human Erythropoietin Anemia 10,000 IU, 20,000 IU, 40,000 IU Approved India BIOSIMILAR PRODUCTS Product name Main Indication Unit Size Status Sold In (Countries) Recombinant Human Interleukin-2 Oncologic. Hepatitis B 0.2 MIU/vial, 0.5 MIU/vial, Approved China 1 MIU/vial, 2 MIU/vial Recombinant Human Interferon ·-2b Lymphatic or haemopoietic tumor. 1 MIU/vial, 3 MIU/vial, Approved China Hepatitis B & C 5 MIU/vial Influenza vaccine A1/New Caledonia/20/99 (H1N1) 1MIU, 3MIU, 5MIU Approved China A3/Wisconsin/67/2005 (H3N2) B/Malaysia/2506/2004
  • 29. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY PROFILE COMPANY NAME MJ Biopharm, Biotechnology initiatives are focused on development of biology, the innovative COMPANY NAME Established in 2002 NPP FARMAKLON, in 2006 obtained a license for the production MJ Biopharm “bio-pharmaceuticals”. With excellent facilities and expertise of human recombinant DNA Pharmaclon and sale of the first and only in Russia currently patented gamma-interferon: INGARON human insulin Formulations, the efforts are to develop ”Key Knowledge” based on Biological ® (interferon-gamma human recombinant) in two dosage forms - lyophilisates for CITY Entities, leading to manufacture and market of high value bio-therapeutics with global CITY solution for intramuscular and subcutaneous injection and lyophilisates for solution for Gujarat benchmarks.MJ Biopharm is actively engaged in collaborative development efforts with Moscow intranasal administration. known biotechnology groups working on “Peptides” leading to “Key Biological Products” COUNTRY Contact Preson: Dilip Ghosh (dghosh@mj-india.com) COUNTRY Contact Preson: Skalyga Maria (reklama@pharmaclon.ru) India Contact Telephone Number: 91 22 22020644 Russia Contact Telephone Number: 495- 621-69-68 BIOSIMILAR PRODUCTS PACK SHOTS Product name Main Indication Unit Size Status Sold In (Countries) Regular Insulin Injection Soluble EP, Biosynthetic, dervived by Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Human rDNA Technology Insulin Injection, Isophane EP, Biosynthetic, derived by Human Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India rDNA Technology Mixture of Insulin Injection Soluble (30%) and Insulin Injection Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Isophane (70%), Biosynthetic, derived by Human rDNA Technology BIOSIMILAR PRODUCTS Long acting Insulin Zinc Injectable Suspension EP, Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Biosynthetic, derived by Human rDNA Technology Product name Main Indication Unit Size Status Sold In (Countries) Regular Insulin Injection Soluble derived from monocomponent Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Interferon gamma Chronic viral hepatitis B and C, HIV / AIDS 100 000 IU, 500 000 IU, Approved Russia, Pakistan Insulin of Porcine Origin USP infection and TB in the lungs 1,000,000 IU, 2,000,000 IU Insulin Isophane Susp Injection derived from monocomponent Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Insulin of Porcine Origin USP Interferon alfa-2b Acute viral hepatitis B; acute prolonged hepatitis B, 500000 ME, 1000000 IU, Approved Russia, Pakistan Long acting Insulin Injection derived from monocomponent Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India chronic active hepatitis B and D, hepatitis C 3000000 ME, 5000000 ME Insulin of Porcine Origin USP Mixed 30:70 Insulin Injection derived from monocomponent Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Interferon gamma Influenza 100 000 IU Approved Russia, Pakistan Insulin of Porcine Origin USP Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Interferon alfa-2b Preventing and treating influenza and other acute 50 000 IU Approved Russia, Pakistan Regular highly purified Insulin Injection of Bovine Origin USP respiratory viral infections Isophane Susp highly purified Insulin Injection Bovine Origin USP Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Long acting highly purified Insulin Injection Bovine Origin USP Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Mixed 30:70 highly purified Insulin Injection Bovine Origin USP Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India
  • 30. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY PROFILE COMPANY NAME Reliance GeneMedix will initially strive to gain marketing approval in territories where COMPANY NAME A pioneer in the field of biotechnology, Shantha Biotechnics is the first Indian company to Reliance patents have expired or never existed. Our aim is to register our products in the EU, where Shantha develop, manufacture and market a recombinant human healthcare product in India. We are the legal and regulatory pathway for our main products has been set. We are also ultimately committed to breaking new ground in modern biotechnology to address critical healthcare CITY aiming at registering our products in the US, once patents have expired and the legal and CITY needs of the developing world. Shantha is currently focusing its R&D efforts in the Tullamore regulatory pathway is in place. To achieve our aims, we are working proactively with the Hyderabad development of generic biologicals, novel therapeutic antibodies, proteins and vaccines. relevant regulatory authorities. COUNTRY Contact Preson: Conor O'Dea (codea@genemedix.com) COUNTRY Contact Preson: Srinivas Rao (srao@shanthabiotech.com) Ireland Contact Telephone Number: +353 5793 23572 India Contact Telephone Number: 1 516 859 3010 PACK SHOTS PACK SHOTS BIOSIMILAR PRODUCTS BIOSIMILAR PRODUCTS Product name Main Indication Unit Size Status Sold In (Countries) Product name Main Indication Unit Size Status Sold In (Countries) Recombinant Human Interferon ·-2b Lymphatic or haemopoietic tumor. 3 MIU/vial, 5 MIU/vial Approved India r-DNA Hepatitis B Vaccine Hepatitis B 20mcg Approved India Hepatitis B & C 2000, 3000, 4000, 6000, Approved India Recombinant interferon Alfa 2b Hepatitis B and C 3M IU, 5M IU Approved India Erythropoietin (EPO) Anemia 10,000 and 40,000 IU Recombinant human erythropoietin Anemia 2000 IU, 4000 IU Approved India human recombinant Granulocyte Reversing neutropenic conditions 300 mcg/0.5 ml Approved India DPT +H vaccine Diphtheria, Pertussis, Tetanus D: 25 Lf, P:15 IU, T: 5Lf, Approved India Colony Stimulating Factor (G-CSF) and Hepatitis B HBsAg 10mcg Reteplase-Recombinant Tissue Acute myocardial infarction 18mg Approved India Plasminogen Activator Recombinant follitropin beta Fertility hormone 300 IU, 900 IU and 1200 IU Approved India stimulating hormone (r-FSH)
  • 31. OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME Shreya Group origins go back to Moscow, Russia, where Shreya Corporation, the parent Shreya Group company, was established in 1995. Once a one-man trading company, Shreya is today the third largest Marketing & Distribution Company in Russia. Shreya Group has interests in CITY both pharmaceutical and biopharmaceutical products in key therapeutic segments. Mumbai Currently, Shreya operates in Russia, CIS, India, South East Asia and African countries. The Group turnover for the year 2006 was US $ 581 million including US $ 85 million in India. COUNTRY Contact Preson: Sujit Kumar Singh (sujit@Shreya.co.in) India Contact Telephone Number: 91 22 66938222 PACK SHOTS BIOSIMILAR PRODUCTS Product name Main Indication Unit Size Status Sold In (Countries) Recombinant DNA human insulin buccal spray Hypoglycaemia Approved India, Ecuador Regular Insulin Injection Soluble EP, Biosynthetic, dervived Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India by Human rDNA Technology Insulin Injection, Isophane EP, Biosynthetic, derived by Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Human rDNA Technology Mixture of Insulin Injection Soluble (30%) and Insulin Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Injection Isophane (70%), Biosynthetic, derived by Human rDNA Technology Long acting Insulin Zinc Injectable Suspension EP, Hypoglycaemia 40 IU/ml, 100 IU/ml, 100 IU/m Approved India Biosynthetic, derived by Human rDNA Technology Purified Human Urofollitropin Hormone 75 IU, 150 IU Approved India Purified Human Chorionic Gonadotropin Hormone 2000 IU, 5000 IU, 10000 IU Approved India Purified Human Menopausal Gonadotropin Hormone 75 IU, 150 IU Approved India Recombinant human growth hormone (somatropin) Hormone 12 IU / 4mg Approved India

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