- Gland Pharma and Neuland Laboratories have entered a long-term CDMO partnership to establish a dedicated sterile API manufacturing suite in Visakhapatnam, India.
- The collaboration will provide integrated development, scale-up, regulatory support, and commercial manufacturing services, adding approximately 1,400 kg of annual sterile API capacity.
Gland Pharma and Neuland Laboratories have entered into a long-term contract development and manufacturing organization (CDMO) partnership under which Gland Pharma will establish a dedicated sterile API manufacturing suite at its facility in Visakhapatnam, India. The companies said the collaboration will provide an integrated contract manufacturing solution covering development, scale-up, regulatory support, and commercial manufacturing of sterile active pharmaceutical ingredients (APIs).
The new manufacturing suite will be constructed and operated in compliance with cGMP, U.S. FDA, and European Union standards and will leverage Gland Pharma’s aseptic manufacturing expertise. According to the companies, the facility is designed to add approximately 1,400 kg of annual sterile API manufacturing capacity to support growing customer demand.
The partnership combines Neuland Laboratories’ capabilities in complex API development and manufacturing with Gland Pharma’s sterile manufacturing expertise and regulatory experience. The companies said the collaboration is intended to support increasing global demand for sterile APIs used in microparticle depot products and other complex sterile APIs.
“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.”
Srinivas Sadu, Executive Chairman of Gland Pharma
Neuland Laboratories Chief Executive Officer and Managing Director Saharsh Davuluri said demand for sterile APIs continues to grow as pharmaceutical companies develop increasingly complex injectable therapies. The company also disclosed that its board has approved the execution of a ₹40 crore corporate guarantee in favor of Gland Pharma.
