Formulation Manufacturing 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. The facilities are equipped for production flexibility and can switch product lines seamlessly, eliminating need to install additional production lines to meet altered product specifications and market mechanics of demand and supply.

Our facilities have received accreditations from the following regulatory bodies:

  • US FDA (United States Food and Drug Administration)
  • UK’s MHRA (United Kingdom’s Medicines and Health products Regulatory Agency)
  • BGV Germany (Behörde für Gesundheit und Verbraucherschutz – Hamburg)
  • ANVISA Brazil (National Health Surveillance Agency)
  • TGA Australia (Therapeutic Goods Administration)
  • MCC South Africa (Medicines Control Council)
  • WHO (World Health Organization)
  • Health Canada
formulation manufacturing facilities Banner banner_Manufacturing
Dundigal, Hyderabad
formulation manufacturing facilities dundigal

Dundigal, Hyderabad

Our 600,000 sq. ft. flagship sterile injectable facility in Dundigal, Hyderabad - USFDA approved since 2003 - possesses capabilities across various delivery formats.

  • 6 vials lines with 7 lyophilizers: 240 million units / year & 48 million lyo units / year
  • 1 ampoules line: 60 million units / year
  • 2 Pre-Filled Syringes (PFS) lines -: 60 million units / year
  • 2 Bag Filling line: 5 million units / year
  • 1 Ophthalmic line: 45 million units / year
Dundigal, Hyderabad
formulation manufacturing facilities dundigal

Pashamylaram, Hyderabad

The sterile injectable facility in Pashamylaram, Hyderabad, after selling in the domestic since July, 2015; obtained USFDA approval in April 2016 and entered the USA market in September 2016. Output at this facility has nearly doubled our manufacturing capacity.

  • 2 vial lines for liquid filling: 132 million units / year
  • 1 vial line with 3 lyophilizers: 18 million units / year
  • 2 ampoule lines: 120 million units / year
Pashamylaram, Hyderabad
formulation manufacturing facilities Pashamylaram
Penems, Hyderabad
formulation manufacturing facilities penems

Penems, Hyderabad

A dedicated Penems facility, after filing its first ANDA in September 2013, obtained USFDA approval in April 2016.

  • Dry powder line: 4 million units / year
  • Liquid vial line with two lyophilizers: 8 million lyo units / year
Penems, Hyderabad
formulation manufacturing facilities penems

Oncology Facility, SEZ Visakhapatnam

Our oncology facility after receiving USFDA and GMP (EU) approval in 2014, began sales in Europe in 2015 and in the United States in 2016.

  • 3 Vial lines with 4 lyophilizers ract: 11 million units / year & 5 million lyo units / year
formulation manufacturing facilities vishkhapatanam
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.

Know More
API Manufacturing Facilities - Gland Pharma Limited
Research & Development

Our two state-of-the-art R&D divisions in Hyderabad are staffed by nearly 300 qualified scientists. The labs engage in Formulation Development, Analytical Method Development, API Process Development and Stability Studies.

Know More
Research & Development Division -  Gland Pharma Limited