Drug Product Development

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Drug Product Development

We offer comprehensive development services for New Chemical Entities (NCEs), generics, and phytopharmaceuticals. Our expertise helps you navigate the regulatory path for IND/CTA/ANDA/NDA applications.

Formulations

  • Pre-formulation profiling and druggability assessment
  • Generic formulation development for parenteral, solid-liquid oral products to support ANDA (NCE 1 /P IV/PIII/PII certifications) applications
  • Development of drug product to support NDA 505 b2) applications
  • Pediatric Formulation Development
  • Drug product development for Phytopharmaceuticals
  • Preclinical formulation development
  • NCE formulation development for FIH (First in Human) and various clinical phases
  • Veterinary formulation development 

Dosage Form Capabilities

  • Solid Orals: Capsules and Tablets with different release profiles (immediate release, delayed release, extended release, sustained release), Effervescent tablets, Chewable tablets, Dispersible tablets, Orally dispersible tablets (ODT), Mouth dissolving tablets, Sub-lingual tablets, Pellets with different release profiles, Pellets into tablets, Bilayer tablets, Mini-tablets in capsules, Liquid-filled capsules.
  • Liquid Orals: Ready-to-use solution, Ready-to-use suspension, Powder for solution, Powder for suspension, Sachets, Emulsions, SEDDs
  • Parenteral: Solutions, Lyophilized products, Peptide injectables, Depot injectables, Ophthalmic formulation, solution for inhalation/nebulization, emulsions, Vials /Ampoules / Pre-filled-Syringes
  • Medical Devices: NPD of Class I, IIA & IIB

Process capabilities

  • Dry Granulation
  • High shear wet granulation
  • Fluid bed granulation
  • Direct compression
  • Fluid bed drying
  • Milling
  • Compression
  • Tablet coating
  • Encapsulation
  • Air jet milling (actives)
  • Palletisation
  • Lyophilisation

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