Formulation Facilities Page


CGMP-COMPLIANT 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 been inspected by the following regulatory bodies and received several product approvals:

  • 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)
cGMP-compliant formulation manufacturing facilities - Gland Pharma Limited
Dundigal, Hyderabad
Sterile injectable facility in Dundigal, Hyderabad - Gland Pharma Limited

Dundigal, Hyderabad

Our 600,000 sq. ft. flagship sterile injectable facility in Dundigal, Hyderabad has been manufacturing products to the USA since 2004, 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
Sterile injectable facility in Dundigal, Hyderabad - Gland Pharma Limited

Pashamylaram, Hyderabad

Our 584,459 sq. ft. state of the art sterile facility at Pashamylaram, Hyderabad, commissioned in July 2012, started manufacturing products to the US market from 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
Sterile injectable facility in Pashamylaram, Hyderabad - Gland Pharma Limited
Penems, Hyderabad
Manufacturing facility in Penems, Hyderabad - Gland Pharma Limited

Penems, Hyderabad

A dedicated Penems facility, after filing its first ANDA in September 2013, started manufacturing products to the US market from April 2016.

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

Oncology Facility, SEZ Visakhapatnam

Our oncology facility, commissioned in the year 2010 started manufacturing products to the US in 2016 and to EU in 2015.

  • 3 Vial lines with 4 lyophilizers ract: 11 million units / year & 5 million lyo units / year
Visakhapatnam
Oncology facility in Sez Visakhapatnam - Gland Pharma Limited
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
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.

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Research & Development Division -  Gland Pharma Limited