Trusted Partners for Innovation and Business Edge Presents
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
Pharma Value Chain Contract Research Clinical Development Contract Manufacturing time Product Profitability Alyante’s Service Area Clinical Supply Chemical and Pharma Development Polymorph Studies & Impurity Synthesis Metabolite Studies BA / BE Studies IP & Patent Protection Strategies Complete filing support Commercial Supply BA / BE Studies IP & Patent Protection Strategies Complete filing support 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
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
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
Asymmetric synthesis / Chiral Separation Peptide synthesis Biocatalytic reactions Varied Temperature range (-80°C to 120°C) High pressure reactions (Up to 2Kg/cm 2  in SS reactors)  Polymorph Preparation (Spray dryer facility available) High Temperature & Pressure, Cryogenic and Organometalic Reactions Dedicated GMP Pilot-plant facility to cater 50-100 Kg of APIs Chemical   Capabilities Wockhardt Business Initiative
Development, Scale-up and Technology Transfer of all type of Dosage forms Injectable dosage forms with delivery devices such as Pens, PFS, Cartridges Ophthalmic & OTIC dosage forms Quick development of Immediate Release Solid and Liquid Orals Developing and commercializing Modified, Dual, Delayed Release Products Formulations  Diversity Wockhardt Business Initiative
Bi-layer, Multi-layer, Tablet-in-tablet technologies Effervescent, Orally Dissolving, Chewable, Sublingual Tablets Platform Technologies for complex products Regulatory and IP Support for all Filing activities Formulations  Diversity Wockhardt Business Initiative
Instrumentation support for NCEs and Formulations development 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  Analytical Excellence Wockhardt Business Initiative
Dedicated teams for method development, validation and routine analysis Walk-in Stability chambers Microbiological Testing Analytical Excellence Wockhardt Business Initiative
Bulk Active’s Manufacturing Manufacturing from India 50 L to 1500 L reaction volume SS, GL and MSGL reactors Pressure upto 2 kg / cm 2 Filteration Equipment Centrifuges of 14” and 24”  Φ Nutsch Filter (Dia 16”) / Pressure Nutcsh filter (Dia 18”) Sparkler filter (8.5”  ΦX  8 plates) Drying Equipment VTD ; FBD ; RCVD ; Spray dryer (Glass) Wockhardt Business Initiative
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
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
API List  Under Development Wockhardt Business Initiative Tolterodine Tartrate Ropinirole Prasugrel Palonosetron Olanzapine Fesoterodine Fexofenadine Dronedarone Des venlafaxine Cefepime Aripiprazole Armodafinil APIs under development
Finished Dosage Manufacturing  @ India Wockhardt Business Initiative
Finished Dosage Manufacturing  ex-India Wockhardt Business Initiative
Biopharmaceutical Value Chain Manufacturing Established facilities for  meeting global requirements -  Pilot plant Biotech Plant Biopharmaceutical facility Regulatory Registrations  69 Product Registrations received 94 registrations in pipeline Commercial SBU established Marketing in ~30 countries  Concept to Commercialization Capabilities R & D 6 Biotech products developed rhu Insulin,  r Erythropoeitin, rhu ins Glargine Wockhardt Business Initiative
The Project  Philosophy Receiving RFP post CDA execution Evaluation and Proposal submission Proposal Discussion Project Awarded BD BD & Team Customer Contact Point Setting up the project team Project kick-off telecon Continuous Updates Prompt & Transparent reporting  Customer sign-off post completion Final Report submission Wockhardt Business Initiative
Alyante is… beyond profits… an Assurance… about unlocking greater value in your research… … about Trust and Commitment Excellence in Execution… …  it’s about relationships … and an alliance beyond projects …  and keeps you always ahead of the competition Excellence with Alyante! Wockhardt Business Initiative
Committed Service - Quick and timely development - Ensured Quality Work - Excellent Cost Management Customized Service -  Tailor made, specific solutions for your needs - Flexibility in development - Quick resolution of issues - Complete confidentiality and active support in case of any IP issue Alyante is  To Serve our Partners Wockhardt Business Initiative
Why   ? Seasoned Team to  address all  requirements Active Ingredients Finished Dosages Analytical Support Clinical Supplies Patent Services NDDS Broadest Spectrum of Infrastructure Extensive  Regulatory Expertise Commercial Supplies Exclusive Mfg Own Clinical Research Organization In – House IP and RA team > 45 DMFs  > 150 ANDAs End to End Drug Development Partner Wockhardt Business Initiative
Thank You 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

Alyante Introduction Presentation

  • 1.
    Trusted Partners forInnovation and Business Edge Presents
  • 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.
    Pharma Value ChainContract Research Clinical Development Contract Manufacturing time Product Profitability Alyante’s Service Area Clinical Supply Chemical and Pharma Development Polymorph Studies & Impurity Synthesis Metabolite Studies BA / BE Studies IP & Patent Protection Strategies Complete filing support Commercial Supply BA / BE Studies IP & Patent Protection Strategies Complete filing support 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.
    Alyante Advantage LeadFinalization 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.
    N O VE 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.
    Asymmetric synthesis /Chiral Separation Peptide synthesis Biocatalytic reactions Varied Temperature range (-80°C to 120°C) High pressure reactions (Up to 2Kg/cm 2 in SS reactors) Polymorph Preparation (Spray dryer facility available) High Temperature & Pressure, Cryogenic and Organometalic Reactions Dedicated GMP Pilot-plant facility to cater 50-100 Kg of APIs Chemical Capabilities Wockhardt Business Initiative
  • 7.
    Development, Scale-up andTechnology Transfer of all type of Dosage forms Injectable dosage forms with delivery devices such as Pens, PFS, Cartridges Ophthalmic & OTIC dosage forms Quick development of Immediate Release Solid and Liquid Orals Developing and commercializing Modified, Dual, Delayed Release Products Formulations Diversity Wockhardt Business Initiative
  • 8.
    Bi-layer, Multi-layer, Tablet-in-tablettechnologies Effervescent, Orally Dissolving, Chewable, Sublingual Tablets Platform Technologies for complex products Regulatory and IP Support for all Filing activities Formulations Diversity Wockhardt Business Initiative
  • 9.
    Instrumentation support forNCEs and Formulations development 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 Analytical Excellence Wockhardt Business Initiative
  • 10.
    Dedicated teams formethod development, validation and routine analysis Walk-in Stability chambers Microbiological Testing Analytical Excellence Wockhardt Business Initiative
  • 11.
    Bulk Active’s ManufacturingManufacturing from India 50 L to 1500 L reaction volume SS, GL and MSGL reactors Pressure upto 2 kg / cm 2 Filteration Equipment Centrifuges of 14” and 24” Φ Nutsch Filter (Dia 16”) / Pressure Nutcsh filter (Dia 18”) Sparkler filter (8.5” ΦX 8 plates) Drying Equipment VTD ; FBD ; RCVD ; Spray dryer (Glass) Wockhardt Business Initiative
  • 12.
    Commercial API ListWockhardt 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.
    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.
    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.
    Finished Dosage Manufacturing @ India Wockhardt Business Initiative
  • 16.
    Finished Dosage Manufacturing ex-India Wockhardt Business Initiative
  • 17.
    Biopharmaceutical Value ChainManufacturing Established facilities for meeting global requirements - Pilot plant Biotech Plant Biopharmaceutical facility Regulatory Registrations 69 Product Registrations received 94 registrations in pipeline Commercial SBU established Marketing in ~30 countries Concept to Commercialization Capabilities R & D 6 Biotech products developed rhu Insulin, r Erythropoeitin, rhu ins Glargine Wockhardt Business Initiative
  • 18.
    The Project Philosophy Receiving RFP post CDA execution Evaluation and Proposal submission Proposal Discussion Project Awarded BD BD & Team Customer Contact Point Setting up the project team Project kick-off telecon Continuous Updates Prompt & Transparent reporting Customer sign-off post completion Final Report submission Wockhardt Business Initiative
  • 19.
    Alyante is… beyondprofits… an Assurance… about unlocking greater value in your research… … about Trust and Commitment Excellence in Execution… … it’s about relationships … and an alliance beyond projects … and keeps you always ahead of the competition Excellence with Alyante! Wockhardt Business Initiative
  • 20.
    Committed Service -Quick and timely development - Ensured Quality Work - Excellent Cost Management Customized Service - Tailor made, specific solutions for your needs - Flexibility in development - Quick resolution of issues - Complete confidentiality and active support in case of any IP issue Alyante is To Serve our Partners Wockhardt Business Initiative
  • 21.
    Why ? Seasoned Team to address all requirements Active Ingredients Finished Dosages Analytical Support Clinical Supplies Patent Services NDDS Broadest Spectrum of Infrastructure Extensive Regulatory Expertise Commercial Supplies Exclusive Mfg Own Clinical Research Organization In – House IP and RA team > 45 DMFs > 150 ANDAs End to End Drug Development Partner Wockhardt Business Initiative
  • 22.
    Thank You Contactus @ 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