Gland Pharma Limited and Neuland Laboratories Limited have entered into a long-term strategic partnership to strengthen sterile Active Pharmaceutical Ingredient (API) manufacturing capabilities. The collaboration brings together the complementary strengths of both companies to deliver integrated Contract Development and Manufacturing Organization (CDMO) services for the global pharmaceutical industry.
As part of the agreement, 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 be built to current Good Manufacturing Practice (cGMP), USFDA and European Union regulatory standards, reinforcing the companies’ commitment to quality, compliance and global manufacturing excellence.
The partnership combines Neuland Laboratories’ expertise in complex API development, process chemistry and custom manufacturing with Gland Pharma’s proven capabilities in sterile manufacturing and aseptic production. Together, the companies aim to address the growing worldwide demand for sterile APIs used in advanced injectable therapies and other complex pharmaceutical products.
The new manufacturing suite will add approximately 1,400 kilograms of annual sterile API production capacity. It has been designed to provide manufacturing flexibility across multiple products while supporting future expansion. The companies will jointly offer end-to-end CDMO services covering product development, process scale-up, regulatory support and commercial manufacturing, enabling customers to access an integrated solution from development through commercialization.
The collaboration also seeks to strengthen global supply chain resilience by combining Neuland’s scientific and regulatory expertise with Gland Pharma’s large-scale sterile manufacturing infrastructure. The dedicated platform is expected to support innovator as well as generic pharmaceutical companies seeking reliable manufacturing partners for complex sterile APIs.
Commenting on the partnership, Srinivas Sadu, Executive Chairman of Gland Pharma Limited, said, “We are pleased to deepen our association with Neuland through this strategic partnership. This investment enhances our sterile API manufacturing capabilities and enables us to meet increasing customer demand. By combining the strengths of both organisations, we will deliver a scalable CDMO platform built on quality, regulatory compliance and manufacturing excellence while creating long-term value for our customers.”
Saharsh Davuluri, CEO and Managing Director of Neuland Laboratories Limited, said, “The demand for sterile APIs is growing as pharmaceutical companies develop increasingly complex injectable therapies. This collaboration brings together Neuland’s expertise in complex APIs and Gland Pharma’s proven sterile manufacturing capabilities, enabling us to provide global customers with high-quality, reliable and dependable CDMO solutions.”
Gland Pharma Limited is a leading Indian pharmaceutical company specializing in injectable formulations and ophthalmic products, with a strong focus on complex generics. Headquartered in Hyderabad, the company has built a reputation for its capabilities in sterile injectables, which are among the most technically demanding segments of the pharmaceutical industry.
Gland Pharma serves regulated and semi-regulated markets, with the United States being its largest market. A significant portion of its revenue comes from supplying generic injectables to global pharmaceutical companies through long-term partnerships, as well as through its own product filings.
The company’s portfolio spans therapeutic areas such as oncology, anti-infectives, cardiovascular, central nervous system, and pain management. The company operates multiple manufacturing facilities in India, most of which are approved by major global regulatory authorities including the US Food and Drug Administration (USFDA).
Its emphasis on compliance, quality systems, and process automation has helped it maintain consistent regulatory standards. Innovation and cost-efficient manufacturing are central to Gland Pharma’s strategy. By focusing on complex molecules, difficult-to-manufacture dosage forms, and limited-competition products, the company aims to strengthen margins and reduce commoditization risks. With a growing pipeline of injectable products and expanding global reach, Gland Pharma continues to position itself as a key player in the global generic injectables market.
