Gland Pharma and Neuland Laboratories have announced a long-term strategic collaboration to strengthen sterile Active Pharmaceutical Ingredient (API) manufacturing and address rising global demand for complex injectable therapies.

 

Under the partnership, Gland Pharma will establish a dedicated sterile manufacturing suite for APIs used in microparticle depot products at its JNPC facility in Visakhapatnam. The new facility will be built and operated to meet cGMP, USFDA and EU standards, leveraging Gland Pharma’s expertise in aseptic manufacturing and regulatory compliance.

 

The collaboration brings together Neuland Laboratories’ capabilities in complex API development, process development and custom manufacturing with Gland Pharma’s global sterile manufacturing capabilities. The partnership aims to provide an integrated CDMO platform covering development, scale-up, regulatory support and commercial manufacturing of sterile APIs.

 

The new sterile suite is expected to add approximately 1,400 kg of annual capacity, offering manufacturing flexibility across multiple sterile products while supporting future growth. The companies said the partnership will enhance global supply resilience by combining Neuland’s expertise in complex APIs and regulatory capabilities with Gland Pharma’s manufacturing strengths.

 

The agreement marks a significant expansion of the relationship between the two companies, creating a dedicated manufacturing platform designed to meet growing demand from global pharmaceutical innovators and generic drug companies.

 

Srinivas Sadu, Executive Chairman, Gland Pharma Limited, 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 Limited, 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."