Neuland, Gland Pharma Partner on Sterile API Manufacturing

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Neuland Laboratories Limited is expanding 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.

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.

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.

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.

Saharsh Davuluri, CEO & MD, Neuland Laboratories Limited, said, “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.”

Srinivas Sadu, Executive Chairman, Gland Pharma Limited, added, “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.”