Gland Pharma, Neuland Laboratories enter long-term CDMO partnership for sterile APIs

Gland Pharma and Neuland Laboratories have announced a long-term strategic contract development and manufacturing organisation (CDMO) partnership to manufacture sterile active pharmaceutical ingredients (APIs) for microparticle depot products.

Under the partnership, Gland Pharma will establish a sterile manufacturing suite for APIs related to microparticle depot products. According to the companies, the collaboration combines Neuland’s complex API development and manufacturing capabilities, including expertise in complex chemistry, process development and custom manufacturing, with Gland Pharma’s sterile manufacturing capabilities and regulatory compliance to serve demand for sterile APIs used in microparticle depot products and other sterile APIs.

The companies stated that the collaboration expands their existing relationship by creating a manufacturing platform that aligns their capabilities under a long-term partnership. As part of the collaboration, Gland Pharma will expand its sterile manufacturing infrastructure by adding a dedicated suite at its JNPC facility in Visakhapatnam to support Neuland’s demand for sterile APIs.

According to the companies, the facility will be constructed and operated in compliance with cGMP, USFDA and European Union standards and will be supported by Gland Pharma’s aseptic manufacturing capabilities. Together, the companies will offer a CDMO solution covering development, scale-up, regulatory support and commercial manufacturing of sterile APIs.

The companies stated that the manufacturing suite will add approximately 1,400 kg of annual capacity, providing manufacturing flexibility across multiple sterile products while supporting future growth.

According to the companies, the partnership is expected to strengthen global supply by combining Neuland’s development and regulatory capabilities with Gland Pharma’s manufacturing infrastructure.

Commenting on the development, Srinivas Sadu, Executive Chairman, Gland Pharma, 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. By leveraging the complementary strengths of both organizations, we will provide a robust and scalable CDMO solution backed by world-class quality, compliance and manufacturing excellence. We believe this partnership creates a strong foundation for sustainable growth and long-term value creation for our customers and both organizations.”

Saharsh Davuluri, CEO & MD, Neuland Laboratories, 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 to create a differentiated platform for global customers. Together, we are strengthening our ability to deliver the quality, reliability, and supply assurance that innovators and generic companies expect from their CDMO partners.”

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