Gland Pharma and Neuland Laboratories on Wednesday announced a long-term strategic contract development and manufacturing partnership to expand sterile API production.
Under the partnership, Gland Pharma will establish a dedicated sterile manufacturing suite for Active Pharmaceutical Ingredients used in microparticle depot products, according to a press release.
The collaboration combines Neuland's complex API development and manufacturing capabilities, including expertise in complex chemistry, process development and custom manufacturing, with Gland Pharma's global sterile manufacturing expertise.
The partnership aims to meet the growing global demand for sterile APIs used in microparticle depot products and other complex sterile APIs, it said.
As part of the collaboration, Gland Pharma will expand its existing sterile manufacturing infrastructure by adding a dedicated suite at its facility in Visakhapatnam to support Neuland's growing demand for sterile APIs.
The facility will be built and operated in compliance with cGMP, USFDA and EU standards and backed by Gland Pharma's proven aseptic manufacturing expertise, it said.
Together, the companies will offer an integrated contract development and manufacturing solution covering development, scale-up, regulatory support and commercial manufacturing of sterile APIs, the release said.
Gland Pharma Ltd Executive Chairman Srinivas Sadu 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." Neuland Laboratories Ltd CEO and Managing Director Saharsh Davuluri said: "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 contract development and manufacturing partners," Davuluri added.




















