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Pharmaceutical Development Services

Pharmaceutical Development Services
We offer Pharmaceutical Development Services for various dosage forms like Oral solids, Semi-Solids and Liquids (Sterile and Non-Sterile) from our facilities across UK and India. Being an integrated global solution provider we have the flexibility to simultaneously engage our facilities for conducting parallel development work to reduce the go-to-market time and costs for our customers

Pharmaceutical Development Capabilities

  • Phase I to III Clinical Development (NCEs)
    • Powder-in-bottle to Drug-in-capsules
    • Liquid filled capsules
    • Comparator Studies
  • Formulation Development in Various Dosage Forms
    • Conventional Oral Solid Dosages
    • Press coated tablets (Sub Coated Tablets)
    • Bi-layered, Delayed release, Modified release, etc.
    • Sterile Liquids – Injectable  & Ophthalmic
    • Semi Solid Formulations
    • Ophthalmic Products
  • Complete ANDA / CTD dossier development
  • 505 (b) (2) development & Para IV filing for ‘first to file’ status
  • Paediatric formulations
  • Hormonal Formulations (Oral Contraceptive Pills)
  • Controlled Drug Substances
  • Oncology Molecules (Sterile and Solid Dosages)

Salient Features of Pharmaceutical Development

  • Supports development to Clinical manufacturing (50 g to 35 kg)
  • Blinding by over-encapsulation
  • Dedicated Pilot Plant manager and QA for batch releases
  • Capability to handle Low RH compounds handling (<30%)
  • High-potency compounds (OEL: 1 mcg/cu.m)
  • Design of experiments using Statistica software
  • Multi-particulates (GPCG 2 and 30)
  • Explosion-proof area for handling non-aqueous solvents
  • Specialized IPQC tools such as Geopyc, Shulze Ring-shear tester for powder / compacts evaluation, sifting & fluidization type segregation testers

Site

  • Mumbai-India
  • Ahmedabad-India
  • Morpeth-UK
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