Neuland Laboratories Limited expands its sterile API manufacturing capacity through a strategic partnership with Gland Pharma, which will establish a dedicated sterile API manufacturing suite for Neuland’s exclusive use.

The collaboration will enable Neuland to meet a growing worldwide demand for sterile APIs used in microparticle depot products and other complex sterile APIs. These capabilities are needed for certain complex APIs that cannot tolerate a terminal sterilization step or are difficult to sterile-filter post production.

Many complex APIs present manufacturing challenges arising from their chemistry, physical properties and formulation requirements. By combining Neuland’s expertise in complex API development and manufacturing with Gland Pharma’s aseptic manufacturing capabilities, the partnership will provide customers with a more integrated pathway from development through to commercial supply, while maintaining the highest standards of quality and compliance.

Under the collaboration, Gland Pharma will expand its existing sterile manufacturing infrastructure through an additional dedicated suite at its JNPC facility at Visakhapatnam to support Neuland’s growing customer demand for sterile APIs. The facility will be constructed and operated to cGMP, USFDA and EU standards.

This deal forms part of a wider global technology partnering strategy, through which Neuland is bringing niche and specialist capabilities to serve its growing customer base, as increasingly complex molecules require more specialised development and manufacturing technologies. Crucially, the Gland Pharma collaboration adds access to aseptic manufacturing expertise alongside dedicated capacity. The approach enables Neuland to broaden the technologies available to customers while continuing to provide an integrated development and manufacturing service through a single partner.

Neuland is expanding its ability to support customers developing niche products that demand specialized handling, stringent aseptic sterilization processes, and deep technical expertise, particularly generic pharmaceutical companies seeking a single manufacturing partner for development and commercial supply. The suite will be designed to add approximately 1,400 kg of annual capacity, providing manufacturing flexibility across multiple sterile products while supporting future growth.

Mr. Saharsh Davuluri, CEO & MD, Neuland Laboratories Limited, said: “Demand for sterile APIs continues to grow as pharmaceutical companies advance increasingly complex injectable therapies. Through this partnership with Gland Pharma, we are combining Neuland’s expertise in complex APIs with Gland’s proven sterile manufacturing capabilities, strengthening our ability to deliver the quality, reliability and supply assurance Neuland customers expect”.

Mr. Srinivas Sadu, Executive Chairman, Gland Pharma Limited, said: “We are pleased to further strengthen our collaboration with Neuland through this strategic partnership. This investment expands our capabilities in sterile API manufacturing and supports increasing customer demand.”