Gland Pharma, Neuland enter into long-term sterile API CDMO partnership | Hyderabad News
Hyderabad: Gland Pharma Limited and Neuland Laboratories Limited have entered into a long-term strategic contract development and manufacturing (CDMO) partnership to expand sterile active pharmaceutical ingredient (API) production for complex injectable therapies.Under the agreement, Gland Pharma will build a dedicated sterile manufacturing suite at its JNPC facility in Visakhapatnam to support Neuland’s rising requirements for sterile APIs used in microparticle depot products and other complex sterile ingredients.The new suite will be designed, constructed and operated in line with cGMP, US Food and Drug Administration and European Union standards, the two Hyderabad-based companies said on Wednesday.The companies said the facility will add about 1,400 kg of annual capacity and provide flexibility to manufacture multiple sterile products.The partnership combines Neuland’s capabilities in complex API development, process chemistry, scale-up, regulatory support and custom manufacturing with Gland Pharma’s sterile manufacturing experience and compliance record.The collaboration, which is an expansion of an existing relationship between the two companies, is aimed at improving global supply resilience for innovators and generic drugmakers.Gland Pharma executive chairman Srinivas Sadu said the investment would strengthen the company’s sterile API capabilities and help meet increasing customer demand through a scalable CDMO offering.Neuland Laboratories managing director & CEO Saharsh Davuluri said demand for sterile APIs is rising as pharmaceutical companies develop more complex injectable therapies.Gland Pharma, founded in 1978, manufactures and supplies sterile injectables across more than 60 countries and is known as the pioneer of Heparin technology in India.Neuland caters to customers in more than 80 countries and operates three US FDA and EU GMP-compliant manufacturing facilities in India, with a combined reactor capacity of about 1,218 kL.
