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Gland Pharma Limited is a Hyderabad-based global injectable manufacturer founded in 1978 by P.V.N. Raju. The company develops, manufactures and markets complex generic injectables across formats such as pre-filled syringes, vials (liquid and lyophilised), ampoules, bags and eye drops, backed by in-house API capabilities and a strong Contract Development and Manufacturing Organisation (CDMO) focus. Operations span over 60 countries, including the United States, Europe, Canada, Australia, New Zealand and India, supported by 11 plants across formulations and APIs.
The company operates primarily on a B2B model globally, complemented by a direct B2C presence in India; services include contract development, dossier compilation, technology transfer and manufacturing across delivery systems. As of March 31, 2025, Gland Pharma has 10 subsidiaries (including step-down subsidiaries) .
Key milestones include: incorporation in 1978; USFDA approval for the Dundigal facility (2003); launch of Enoxaparin Sodium Injection (Cutenox) in India and rest-of-world markets (2004–05); USFDA and EU approvals for the Oncology plant at Visakhapatnam SEZ (2014); commencement of US commercial sales from the Pashamylaram facility and multiple facility approvals (2016); majority stake acquisition by Fosun Singapore (2019); and the acquisition of Cenexi to strengthen the CDMO build-out (2023). During FY 2024–25, the company also highlighted additional production lines for newer formats such as ready-to-use products, sterile cartridges and specialty vials being installed and ready for commercial production .
– By business model (FY 2024–25 revenue mix):
– B2B – IP-led (Own ANDA): 33%
– B2B – IP-led (Partner ANDA): 25 Per cent
– B2B – Tech Transfer: 41%
– B2C – India: 1%
– By markets (FY 2024–25 revenue mix):
– USA: 54%; Europe: 19%; India: 4%; Canada: 2%; Australia: 2%; Rest of World: 19%.
– Srinivas Sadu – Executive Chairman
– Shyamakant Giri – Chief Executive Officer
– Ravi Shekhar Mitra – Chief Financial Officer
– P. Sampath Kumar – Company Secretary
– Regulatory: The Dundigal and Pashamylaram facilities received Establishment Inspection Reports (EIRs) from the USFDA during the year, underscoring a strong compliance track record .
– Capacity and technology: New lines for suspensions, hormonal products, peptides and microspheres have been installed; additional production lines for ready-to-use products, sterile cartridges, pre-filled syringes, dry powder and liquid vials, bulk cartridges and specialty vials were readied for commercial production .
– Strategic collaborations: The company advanced its foray into complex CDMO and biologies, including a long-term collaboration with Dr. Reddy’s Laboratories at its biologies facility in Genome Valley, Hyderabad, and collaboration with Shanghai Henlius Biotech for biosimilar manufacturing; it is also focusing on GLP-1 products, with two CDMO contracts onboarded .
– International footprint: Integration of Cenexi, a European CDMO with expertise in sterile liquid and lyophilised fill-finish formulations including oncology, continued to enhance Gland’s overseas manufacturing presence and CDMO offerings in Europe .
The company focuses on complex generic injectables across formats like pre-filled syringes, vials, ampoules and bags, supported by in-house API capabilities and a strong CDMO model. It also operates a direct B2C business in India .
Gland Pharma serves over 60 countries, with a strong presence in the United States, Europe, Canada, Australia, New Zealand and India.
As of March 31, 2025, Gland Pharma has 10 subsidiaries, including step-down subsidiaries in Europe and North America. These include entities within the Cenexi group, which strengthens its CDMO footprint in Europe .