Alyante Introduction Presentation

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Alyante is a custom research services organisation that delivers quality research to help improve your research efficiencies. It provides comprehensive end-to-end solutions ranging from chemical and pharmaceutical development to product supply, including complete regulatory support for filing. To enhance your product portfolio, Alyante offers innovative services including NDDS.
Alyante’s array of innovation-based services and commitment to excellence will help you create new value.
Alyante is an assurance of an alliance that strives to keep your research always ahead of the competition through innovation and trust.

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Alyante Introduction Presentation

  1. 1. Trusted Partners for Innovation and Business Edge Presents
  2. 2. Wockhardt India & RoW Wockhardt US Wockhardt UK & Ireland Wockhardt France R&D Center 8 API Plants 8 Formulation Plants Finished Dosage Plant @ Morton Grove Finished Dosage Plant @ Wrexham, UK & Pinewood, Ireland 1 API Plant @ Quimper, France 1 Finished Dosage Plant @ Mazal, France 40 yrs of Experience & World class Capabilities Wockhardt Business Initiative
  3. 3. Pharma Value Chain Contract Research Clinical Development Contract Manufacturing time Product Profitability Alyante’s Service Area <ul><li>Clinical Supply </li></ul><ul><li>Chemical and Pharma Development </li></ul><ul><li>Polymorph Studies & Impurity Synthesis </li></ul><ul><li>Metabolite Studies </li></ul><ul><li>BA / BE Studies </li></ul><ul><li>IP & Patent Protection Strategies </li></ul><ul><li>Complete filing support </li></ul><ul><li>Commercial Supply </li></ul><ul><li>BA / BE Studies </li></ul><ul><li>IP & Patent Protection Strategies </li></ul><ul><li>Complete filing support </li></ul>Wockhardt’s Services Target Identification & Validation Compound Generation, Screening & Lead Optimization Preclinical BA / BE Human Trials API Mfg Formulation Mfg Manufacturing & Marketing Wockhardt Business Initiative
  4. 4. Alyante Advantage Lead Finalization Pre Clinical Clinical Trials Commercialized Growth Mature $ Costs Revenues Cost Reduction 1 st Alyante Adv Patent Extension 2 nd Alyante Adv Early to Market On Patent Off Patent Early to market Late to market Wockhardt Business Initiative
  5. 5. N O V E L T Y Chiral Resolution Stable & Novel Polymorphs Non Infringing Process NDDS Development Modified Release forms Dose Reduction / Optimization Strategies Targeted Drug Delivery Systems Creating a Patent Portfolio Maximize Innovations Patent Extension Services Isolation, Characterization & Synthesis of Impurities Wockhardt Business Initiative
  6. 6. <ul><li>Asymmetric synthesis / Chiral Separation </li></ul><ul><li>Peptide synthesis </li></ul><ul><li>Biocatalytic reactions </li></ul><ul><li>Varied Temperature range (-80°C to 120°C) </li></ul><ul><li>High pressure reactions (Up to 2Kg/cm 2 in SS reactors) </li></ul><ul><li>Polymorph Preparation (Spray dryer facility available) </li></ul><ul><li>High Temperature & Pressure, Cryogenic and Organometalic Reactions </li></ul><ul><li>Dedicated GMP Pilot-plant facility to cater 50-100 Kg of APIs </li></ul>Chemical Capabilities Wockhardt Business Initiative
  7. 7. <ul><li>Development, Scale-up and Technology Transfer of all type of Dosage forms </li></ul><ul><li>Injectable dosage forms with delivery devices such as Pens, PFS, Cartridges </li></ul><ul><li>Ophthalmic & OTIC dosage forms </li></ul><ul><li>Quick development of Immediate Release Solid and Liquid Orals </li></ul><ul><li>Developing and commercializing Modified, Dual, Delayed Release Products </li></ul>Formulations Diversity Wockhardt Business Initiative
  8. 8. <ul><li>Bi-layer, Multi-layer, Tablet-in-tablet technologies </li></ul><ul><li>Effervescent, Orally Dissolving, Chewable, Sublingual Tablets </li></ul><ul><li>Platform Technologies for complex products </li></ul><ul><li>Regulatory and IP Support for all Filing activities </li></ul>Formulations Diversity Wockhardt Business Initiative
  9. 9. <ul><li>Instrumentation support for NCEs and Formulations development </li></ul><ul><li>State-of-the-art instruments such as UPLC, HPLC, GC, NMR, XRD, DSC, LC-MS, GC-MS, FTIR, Malvern Particle Size Analyzer and Dissolution Apparatus </li></ul>Analytical Excellence Wockhardt Business Initiative
  10. 10. <ul><li>Dedicated teams for method development, validation and routine analysis </li></ul><ul><li>Walk-in Stability chambers </li></ul><ul><li>Microbiological Testing </li></ul>Analytical Excellence Wockhardt Business Initiative
  11. 11. Bulk Active’s Manufacturing <ul><li>Manufacturing from India </li></ul><ul><li>50 L to 1500 L reaction volume </li></ul><ul><li>SS, GL and MSGL reactors </li></ul><ul><li>Pressure upto 2 kg / cm 2 </li></ul><ul><li>Filteration Equipment </li></ul><ul><ul><li>Centrifuges of 14” and 24” Φ </li></ul></ul><ul><ul><li>Nutsch Filter (Dia 16”) / Pressure Nutcsh filter (Dia 18”) </li></ul></ul><ul><ul><li>Sparkler filter (8.5” ΦX 8 plates) </li></ul></ul><ul><li>Drying Equipment </li></ul><ul><ul><li>VTD ; FBD ; RCVD ; Spray dryer (Glass) </li></ul></ul>Wockhardt Business Initiative
  12. 12. Commercial API List Wockhardt Business Initiative    Clopidogrel Hydrochloride    Clopidogrel Bisulphate Form 1    Zoledronic Acid    Granisetron    Octreotide Acetate    Oxybutynine Hydrochloride    Ceftazidime for Injection    Sterile Ceftriaxime Sodium    Sterile Ceftriaxone Sodium    Cefuroxime Axetil Amorphous    Dextropropoxyphene Napsylate    Dextropropoxyphene Hydrochloride    Dextromethorphan Hydrobromide CEP EDMF USDMF Commercial APIs
  13. 13. Commercial API List (contd.) Wockhardt Business Initiative    D-Oxyphene Base    Epinephrine    Duloxetine    Donepezil    Ziprasidone HCl    Zonisamide    Zolpidem    Adenosine    Nicardipine    Felodipine    Captopril    Tamsulosin HCl CEP EDMF USDMF Commercial APIs
  14. 14. API List Under Development Wockhardt Business Initiative Tolterodine Tartrate Ropinirole Prasugrel Palonosetron Olanzapine Fesoterodine Fexofenadine Dronedarone Des venlafaxine Cefepime Aripiprazole Armodafinil APIs under development
  15. 15. Finished Dosage Manufacturing @ India Wockhardt Business Initiative
  16. 16. Finished Dosage Manufacturing ex-India Wockhardt Business Initiative
  17. 17. Biopharmaceutical Value Chain Manufacturing <ul><li>Established facilities for meeting global requirements </li></ul><ul><li>- Pilot plant </li></ul><ul><li>Biotech Plant </li></ul><ul><li>Biopharmaceutical facility </li></ul>Regulatory <ul><li>Registrations </li></ul><ul><li>69 Product Registrations received </li></ul><ul><li>94 registrations in pipeline </li></ul>Commercial <ul><li>SBU established </li></ul><ul><li>Marketing in ~30 countries </li></ul>Concept to Commercialization Capabilities R & D 6 Biotech products developed rhu Insulin, r Erythropoeitin, rhu ins Glargine Wockhardt Business Initiative
  18. 18. The Project Philosophy <ul><li>Receiving RFP post CDA execution </li></ul><ul><li>Evaluation and Proposal submission </li></ul><ul><li>Proposal Discussion </li></ul><ul><li>Project Awarded </li></ul>BD BD & Team Customer Contact Point <ul><li>Setting up the project team </li></ul><ul><li>Project kick-off telecon </li></ul><ul><li>Continuous Updates </li></ul><ul><li>Prompt & Transparent reporting </li></ul><ul><li>Customer sign-off post completion </li></ul><ul><li>Final Report submission </li></ul>Wockhardt Business Initiative
  19. 19. Alyante is… <ul><li>beyond profits… </li></ul><ul><li>an Assurance… </li></ul><ul><li>about unlocking greater value in your research… </li></ul><ul><li>… about Trust and Commitment </li></ul><ul><li>Excellence in Execution… </li></ul>… it’s about relationships … and an alliance beyond projects … and keeps you always ahead of the competition Excellence with Alyante! Wockhardt Business Initiative
  20. 20. <ul><li>Committed Service </li></ul><ul><li>- Quick and timely development </li></ul><ul><li>- Ensured Quality Work </li></ul><ul><li>- Excellent Cost Management </li></ul><ul><li>Customized Service </li></ul><ul><li>- Tailor made, specific solutions for your needs </li></ul><ul><li>- Flexibility in development </li></ul><ul><li>- Quick resolution of issues </li></ul><ul><li>- Complete confidentiality and active support in case of any IP issue </li></ul>Alyante is To Serve our Partners Wockhardt Business Initiative
  21. 21. Why ? Seasoned Team to address all requirements <ul><li>Active Ingredients </li></ul><ul><li>Finished Dosages </li></ul><ul><li>Analytical Support </li></ul><ul><li>Clinical Supplies </li></ul><ul><li>Patent Services </li></ul><ul><li>NDDS </li></ul>Broadest Spectrum of Infrastructure Extensive Regulatory Expertise <ul><li>Commercial Supplies </li></ul><ul><li>Exclusive Mfg </li></ul><ul><li>Own Clinical Research Organization </li></ul><ul><li>In – House IP and RA team </li></ul><ul><li>> 45 DMFs </li></ul><ul><li>> 150 ANDAs </li></ul>End to End Drug Development Partner Wockhardt Business Initiative
  22. 22. <ul><li>Thank You </li></ul>Contact us @ Wockhardt Ltd Wockhardt Towers, 6 th Floor (Near National Stock Exchange) Bandra – Kurla Complex Bandra (E) Mumbai – 400 051 Maharashtra, India Phone: +91 22 2653 4444 Fax: +91 22 2653 4242 +91 22 6692 1196 www.wockhardt.com

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