Strategic Partnership Overview
Gland Pharma Limited and Neuland Laboratories Limited have entered into a long-term strategic CDMO partnership for sterile Active Pharmaceutical Ingredients (APIs) manufacturing. The collaboration represents a significant expansion of the existing relationship between the two companies.
Partnership Structure and Manufacturing Details
Under the partnership, Gland Pharma will establish a sterile manufacturing suite specifically for APIs pertaining to microparticle depot products. The new suite will be located at Gland Pharma's JNPC facility in Visakhapatnam and will expand the company's existing sterile manufacturing infrastructure.
Capacity and Technical Specifications
The new sterile suite is designed to add approximately 1400 kg of annual manufacturing capacity. The facility will be constructed and operated to cGMP, USFDA, and EU standards, backed by Gland Pharma's proven aseptic manufacturing expertise. The capacity will provide manufacturing flexibility across multiple sterile products while supporting future growth.
Combined Capabilities
The collaboration combines Neuland Laboratories' complex API development and manufacturing capabilities, including expertise in complex chemistry, process development, and custom manufacturing, with Gland Pharma's global sterile manufacturing expertise and strong regulatory compliance track record.
Integrated CDMO Solution
Together, the companies will offer an integrated CDMO solution encompassing development, scale-up, regulatory support, and commercial manufacturing of sterile APIs. The partnership is expected to serve growing worldwide demand for sterile APIs used in microparticle depot products and other complex sterile APIs.
Management Commentary
Mr. Srinivas Sadu, Executive Chairman, Gland Pharma Limited stated: "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. By leveraging the complementary strengths of both organizations, we will provide a robust and scalable CDMO solution backed by world-class quality, compliance and manufacturing excellence."
Mr. Saharsh Davuluri, CEO & MD, Neuland Laboratories Limited stated: "Demand for sterile APIs continues to grow as pharmaceutical companies advance increasingly complex injectable therapies. 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."
Expected Benefits
The partnership is expected to enhance supply resilience globally by combining Neuland's development and regulatory expertise with Gland Pharma's manufacturing capabilities. The collaboration aims to create a strong foundation for sustainable growth and long-term value creation for customers and both organizations.
Regulatory Compliance Disclosure
The announcement is made pursuant to Regulation 30 read with Part A of Schedule III of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.