Pharmaceutical API Product Research and Development

Our two state-of-the-art R&D divisions in Hyderabad is staffed by nearly 300 qualified scientists. The labs engage in Formulation Development, Analytical Method Development, API Process Development and Stability Studies. Our expertise includes synthesis of complex drug molecules such as LMWH, Corticosteroids, Peptides and Cytotoxic molecules.

As a vertically integrated company, we have seamlessly combined our expertise in research and development (R&D) with state-of-the-art manufacturing set-ups. Together with stringent quality control systems, extensive experience in regulatory procedures, established marketing and distribution infrastructure.

Our exemplary regulatory compliance track record can be gauged from the fact that all our facilities are USFDA approved. Other key global approvals include MHRA (UK), EMA (EU), TGA (Australia), ANVISA (Brazil) and BGV Hamburg (Germany).

gland pharma r&d divisions
Synthetic R&D at gland pharma

Synthetic R&D

  • Process Development for Niche APIs
  • Patent Non-Infringing Process
  • Pilot and Scale-Up Studies
Formulation R&D at gland pharma

Formulation R&D

  • Formulation Development
  • Pre-Formulation Studies
  • Lyo-Cycle Development and Scale-Up
Analytical R&D at gland pharma

Analytical R&D

  • Analytical Method Development and Validation
  • Impurity Determination and Characterization
  • Primary Reference Standard Preparation and Standardization
API Facilities

Our 4 API manufacturing facilities have in-house manufacturing capabilities that help us integrate backwards and develop products that many others may overlook because of API supply uncertainty.

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API Manufacturing Facilities - Gland Pharma Limited
Formulation Facilities

Our four best-in-class, cGMP- compliant formulation manufacturing facilities manufacture a wide range of injectables using aseptic filling or terminal sterilization, as applicable.

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Formulation Manufacturing Facilities - Gland Pharma Limited