Gland Pharma and Neuland Laboratories have entered into a long-term strategic contract development and manufacturing organisation (CDMO) partnership to strengthen their presence in the fast-growing sterile active pharmaceutical ingredient (API) segment.
As part of the collaboration, Gland Pharma will establish a dedicated sterile manufacturing suite for APIs used in microparticle depot products at its JNPC facility in Visakhapatnam. The partnership aims to address the rising global demand for sterile APIs used in complex injectable therapies.
The alliance brings together Neuland Laboratories’ expertise in complex API development, process chemistry and custom manufacturing with Gland Pharma’s proven capabilities in sterile manufacturing and regulatory compliance. Together, the companies plan to offer an integrated CDMO platform covering product development, process scale-up, regulatory support and commercial manufacturing.
Expansion of sterile manufacturing
The collaboration marks a significant expansion of the relationship between the two companies through a dedicated manufacturing platform aligned under a long-term strategic partnership.
Gland Pharma will augment its existing sterile manufacturing infrastructure by setting up an additional dedicated suite to support Neuland’s growing sterile API requirements. The new facility will be designed and operated in compliance with cGMP, USFDA and European regulatory standards.
The facility is expected to add around 1,400 kg of annual sterile API manufacturing capacity, providing flexibility to manufacture multiple sterile products while supporting future growth opportunities.
The partnership is also expected to strengthen global supply chain resilience by combining Neuland’s development and regulatory expertise with Gland Pharma’s large-scale manufacturing capabilities.
Addressing growing demand
Gland Pharma Executive Chairman Srinivas Sadu said the investment would significantly expand the company’s sterile API manufacturing capabilities while addressing growing customer demand.
“By leveraging the complementary strengths of both organisations, 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 organisations,” he said.
Neuland Laboratories CEO & Managing Director Saharsh Davuluri said demand for sterile APIs is increasing as pharmaceutical companies continue to develop more 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,” he said.
Neuland expands CDMO capabilities
Neuland Laboratories has been strengthening its CDMO business through investments in capacity and research infrastructure. The company commissioned a commercial-scale peptide manufacturing facility earlier this year and is setting up a dedicated R&D process development centre in Hyderabad.
Neuland has filed more than 1,000 Drug Master Files (DMFs) globally and offers a portfolio of over 100 APIs across multiple therapeutic areas, serving both innovator and generic pharmaceutical companies.