Neuland Laboratories and Gland Pharma have entered a long-term strategic partnership to expand sterile active pharmaceutical ingredient (API) manufacturing for microparticle depot products and other complex sterile APIs.

Under the agreement, Gland Pharma will add a dedicated sterile manufacturing suite at its JNPC facility in Visakhapatnam, India to support Neuland’s growing demand. The suite will be designed and operated to current Good Manufacturing Practice (cGMP), U.S. Food and Drug Administration (FDA), and European Union standards and is expected to add approximately 1,400 kilograms of annual capacity.

The collaboration combines Neuland’s complex API development, process development, and custom manufacturing capabilities with Gland Pharma’s sterile manufacturing expertise. The companies will provide development, scale-up, regulatory support, and commercial manufacturing of sterile APIs.

Separately, Gland Pharma has signed a strategic manufacturing and supply agreement with an undisclosed global pharmaceutical company covering technology transfer, development, manufacturing, and long-term supply of sterile injectable products for global markets.

The agreement covers 55 SKUs across three Gland Pharma manufacturing sites, including oncology and non-oncology products in vial, lyophilized, ampoule and prefilled syringe presentations. Technology transfer activities are expected to be completed within two years, with revenue generation expected to begin in 2029. Once all products are commercialized, the agreement has an estimated annualized revenue potential of $90 million to $100 million.

The agreement expands Gland Pharma’s role as a CDMO across technology transfer, process development, scale-up, validation, commercial manufacturing, and supply.