Dosage Development Scale Up

Formulation Development


Formulation Development

USV is focused on developing solid oral and sterile dosage forms. In solid oral dosage forms, USV has capability of developing Tablets and Capsules using different manufacturing technologies for immediate as well as modified release drug delivery. In sterile dosage forms, USV has capability of developing injectable and ophthalmic solutions. The sterile dosage forms are filled in Vials, pre-filled syringes, cartridges, pen devices for injectable drug delivery and bottles used for ophthalmic drug delivery.
USV also has a state-of-the-art pilot lab to manufacture clinical supplies for investigational drugs.

USV’s finished product portfolio in major international markets comprises - USA - 45 Abbreviated New Drug Applications (ANDAs) filed. Europe – More than 200 Marketing Authorizations (MAs) across Europe for 23 products. Emerging Market - 180 plus dossier registrations & 60 dossiers under registration in APAC, MENA, SA, LATAM and CIS.

Capabilities
  • Granulation techniques such as wet granulation, dry granulation, hot melt granulation
  • Parenteral drug delivery of small molecules, peptides and biosimilars
  • Modified release solid oral dosage forms
  • Ophthalmic dosage forms
  • OEB class 1 to 4 drugs
Infrastructure
  • Rapid mixer granulators
  • Roller compactors
  • Extruder and spheroniser
  • Fluid bed processor with top spray & Wurster facility
  • Compression machines for single & multilayered tablets
  • Autocoater for pellets and tablets coating
  • Blister packing machines (cold form / Alu poly)
  • Walk-in stability chambers
  • Encapsulator
  • Lyophilizer





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