Gland Pharma and Neuland Laboratories have entered into a long-term CDMO partnership under which the former will be establishing a dedicated suite at its facility in Visakhapatnam to support Neuland’s growing demand of sterile APIs.

Together, they would offer an integrated CDMO (Contract Development and Manufacturing Organization) solution covering development, scale-up, regulatory support and commercial manufacturing of sterile active pharmaceutical ingredients (APIs). The suite, which will be constructed and operated to cGMP, U.S. FDA and EU standards and backed by Gland Pharma’s aseptic manufacturing expertise, will be designed to add around 1,400 kg annual capacity.

Their collaboration combines Neuland’s complex API development and manufacturing capabilities with Gland Pharma’s global sterile manufacturing expertise and regulatory compliance track record. The objective is to serve growing worldwide demand for sterile APIs used in microparticle depot products and other complex sterile APIs, the companies said.

“The investment expands our capabilities in sterile API manufacturing and supports increasing customer demand. By leveraging complementary strengths… we will provide a robust and scalable CDMO solution,” Gland Pharma Executive Chairman Srinivas Sadu said.

Neuland Laboratories CEO and MD Saharsh Davuluri said demand for sterile APIs continues to grow as pharmaceutical companies advance increasingly complex injectable therapies. In a filing, Neuland said its board has approved the execution of deed of corporate guarantee for ₹40 crore in favour of Gland Pharma.