Gland Pharma and Neuland Labs announce strategic collaboration for sterile API manufacturing

Gland Pharma and Neuland Laboratories have announced a long-term strategic CDMO partnership. Under the partnership Gland will establish a sterile manufacturing suite for Active Pharmaceutical Ingredients (APIs) pertaining to microparticle depot products.

The collaboration combines Neuland's Complex API development and manufacturing capabilities including deep expertise in complex chemistry, process development, custom manufacturing having a strong track record of serving global innovator and generic pharmaceutical companies; with Gland Pharma's global sterile manufacturing expertise and strong regulatory compliance track record, to serve growing worldwide demand for sterile APIs used in microparticle depot products and other complex sterile APIs.

The collaboration represents a significant expansion of the relationship between the two companies, creating a dedicated manufacturing platform that aligns their complementary capabilities under a long-term strategic partnership.

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 for its growing demand of sterile APIs. The facility will be constructed and operated to cGMP, USFDA and EU standards, and will be backed by Gland Pharma's proven aseptic manufacturing expertise. Together, the companies will offer an integrated CDMO solution encompassing development, scale-up, regulatory support and commercial manufacturing of sterile APIs. The suite will be designed to add approximately 1400 kg of annual capacity, providing manufacturing flexibility across multiple sterile products while supporting future growth.

The partnership is expected to enhance supply resilience globally by combining Neuland's development and regulatory expertise with Gland Pharma's manufacturing capabilities.