Gland Pharma, Neuland Announce Strategic CDMO Partnership for Complex Sterile APIs
Hyderabad: Gland Pharma Limited and Neuland Laboratories Limited have entered into a long-term strategic Contract Development and Manufacturing Organisation (CDMO) partnership to strengthen sterile active pharmaceutical ingredient (API) manufacturing capabilities for global pharmaceutical customers.
Under the collaboration, Gland Pharma will establish a dedicated sterile manufacturing suite for APIs used in microparticle depot products at its JNPC manufacturing facility in Visakhapatnam. The new facility will support Neuland Laboratories' growing demand for sterile APIs while expanding Gland Pharma's sterile manufacturing infrastructure.
The companies said the partnership combines Neuland's expertise in complex API development, process development, custom manufacturing and regulatory support with Gland Pharma's sterile manufacturing capabilities and regulatory compliance experience to meet the increasing global demand for sterile APIs used in microparticle depot products and other complex sterile injectable therapies.
According to the companies, the manufacturing suite will be designed to operate in compliance with current Good Manufacturing Practices (cGMP), as well as USFDA and European regulatory standards. The facility is expected to add approximately 1,400 kg of annual sterile API manufacturing capacity, providing flexibility across multiple products while supporting future growth.
The collaboration also aims to offer an integrated CDMO solution covering API development, scale-up, regulatory support and commercial manufacturing.
Commenting on the partnership, Srinivas Sadu, Executive Chairman of 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."
Saharsh Davuluri, CEO and Managing Director of Neuland Laboratories, said the demand for sterile APIs continues to grow with the development of 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," he said.
The companies said the partnership is expected to strengthen global supply resilience by combining Neuland's development and regulatory expertise with Gland Pharma's manufacturing capabilities.
Hyderabad-headquartered Gland Pharma is a global injectable-focused pharmaceutical company with operations across more than 60 countries, while Neuland Laboratories is an API-focused CDMO serving innovator and generic pharmaceutical companies in over 80 countries. Neuland currently operates three USFDA- and EU GMP-compliant manufacturing facilities in India and recently expanded its peptide manufacturing and research capabilities.
