Neuland Laboratories and Gland Pharma have inked a long-term strategic CDMO partnership to expand sterile API manufacturing capabilities. Gland Pharma will establish a new, cGMP-compliant sterile suite at its Visakhapatnam facility, adding approximately 1400 kg of annual capacity. This collaboration aims to enhance supply resilience and cater to the growing global demand for sterile APIs used in microparticle depot products and other complex applications.
Strategic Collaboration for Sterile API Production
Neuland Laboratories Limited and Gland Pharma Limited have announced a significant strategic CDMO partnership focused on expanding sterile API manufacturing. This collaboration is set to bolster Neuland’s capacity for producing APIs for microparticle depot products and other complex sterile APIs, addressing the increasing global demand.
Gland Pharma to Establish New Sterile Suite
Under the agreement, Gland Pharma will expand its existing sterile manufacturing infrastructure by establishing an additional dedicated suite at its JNPC facility in Visakhapatnam. This new facility will be constructed and operated to cGMP, USFDA, and EU standards. It is designed to add approximately 1400 kg of annual capacity, providing enhanced manufacturing flexibility and supporting future growth in sterile API production.
Enhanced Capabilities and Market Reach
The partnership combines Neuland’s expertise in Complex API development, chemistry, and process development with Gland Pharma’s global sterile manufacturing expertise and regulatory compliance. This integrated CDMO solution will encompass development, scale-up, regulatory support, and commercial manufacturing of sterile APIs. The companies anticipate this will enhance global supply resilience and meet the evolving needs of innovator and generic pharmaceutical companies.
Financial and Operational Impact
The execution of a Corporate Guarantee for ₹40 crores in favour of Gland Pharma Limited has been approved by the Board of Directors. This guarantee is in connection with a Loan Licence Agreement to establish dedicated manufacturing capacity and incur capital expenditure for specific products. The company has stated that there is no immediate impact on its financials, with the guarantee representing a contingent liability.
Manufacturing Capacity Enhancement
In parallel, the Board also approved the enhancement of manufacturing capacity at Unit 1 in Bonthapally Village, Sangareddy District. The proposed capacity addition is 18 KL, with an investment of approximately ₹39.8 crores (incl GST), to be financed through internal accruals. This expansion is intended to maintain and cater to the growing demand for the company’s products.
Source: BSE
