Gland Pharma, Neuland Laboratories forge strategic partnership for sterile API manufacturing
The Hyderabad-based pharma companies will jointly expand sterile API manufacturing through a dedicated cGMP facility, strengthening global supply of complex injectable therapies.
The partnership brings together Neuland's expertise in complex API development, process chemistry and custom manufacturing with Gland Pharma's global capabilities in sterile manufacturing and regulatory compliance.
HYDERABAD: Gland Pharma Limited and Neuland Laboratories Limited have announced a long-term strategic contract development and manufacturing organisation (CDMO) partnership to expand sterile Active Pharmaceutical Ingredient (API) manufacturing for complex injectable therapies.
Under the collaboration, Gland Pharma will establish a dedicated sterile manufacturing suite for APIs used in microparticle depot products at its Jawaharlal Nehru Pharma City (JNPC) facility in Visakhapatnam. The new facility will support Neuland Laboratories’ growing demand for sterile APIs while combining the complementary strengths of both companies.
The partnership brings together Neuland’s expertise in complex API development, process chemistry and custom manufacturing with Gland Pharma’s global capabilities in sterile manufacturing and regulatory compliance. The companies aim to address the growing worldwide demand for sterile APIs used in microparticle depot products and other complex sterile formulations.
As part of the agreement, Gland Pharma will expand its existing sterile manufacturing infrastructure by adding a dedicated suite designed and operated in compliance with current Good Manufacturing Practices (cGMP), as well as US Food and Drug Administration (USFDA) and European Union regulatory standards.
The new sterile manufacturing suite will add an estimated annual production capacity of approximately 1,400 kilograms, providing manufacturing flexibility across multiple sterile products while supporting future growth.
The collaboration will enable the two companies to offer an integrated CDMO platform covering process development, scale-up, regulatory support and commercial manufacturing of sterile APIs for global pharmaceutical innovators and generic drug manufacturers.
Srinivas Sadu, Executive Chairman of Gland Pharma, said the investment would strengthen the company’s sterile API manufacturing capabilities while supporting increasing customer demand. He added that the partnership would provide customers with a scalable CDMO solution backed by quality, regulatory compliance and manufacturing expertise.
Saharsh Davuluri, CEO and Managing Director of Neuland Laboratories, said demand for sterile APIs is rising as pharmaceutical companies develop increasingly complex injectable therapies. He said the collaboration would enhance the company’s ability to deliver quality, reliability and supply assurance to global customers.
The companies said the partnership is expected to improve global supply resilience by combining Neuland’s development and regulatory expertise with Gland Pharma’s sterile manufacturing capabilities, creating a dedicated platform for serving the evolving needs of the global pharmaceutical industry.
