Supriya Lifescience receives WHO GMP Certification for Ambernath Facility
Approval enables commercial production of formulations with projected revenue potential of ₹500 crore
Supriya Lifescience, a cGMP-compliant manufacturer of Active Pharmaceutical Ingredients (APIs), has announced that its Ambernath facility has received the World Health Organization (WHO) Good Manufacturing Practices (GMP) certification. The certification follows a regulatory audit and allows the company to begin commercial manufacturing and sales of formulations from the site.
The company stated that the WHO GMP approval represents a milestone in its plans to expand beyond APIs into formulations. The Ambernath facility has been designed for the production of injectables, tablets, capsules, and inhalation dosages. The company projects a revenue potential of nearly ₹500 crore at peak capacity from this site. According to the company, margins from this segment are expected to be higher than those of its API business.
As per the FY 2024-25 Annual Report, capacity creation at Ambernath was one of the company’s key initiatives. With the WHO GMP certification now in place, the facility is eligible to supply to WHO-listed and regulated international markets. The company indicated that this development supports its broader formulations strategy. Along with the Lote Parshuram API site, Supriya’s total manufacturing capacity now exceeds 1,020 KL. The company stated that this will improve operational flexibility and asset utilisation.
Commenting on the development, Dr. Satish Wagh, Executive Chairman and Whole-Time Director, Supriya Lifescience, said, “Receiving the WHO GMP certification for Ambernath is a defining achievement for Supriya Lifescience. It validates our quality standards and unlocks the opportunity to scale our formulations business from a state-of-the-art facility. This expansion strengthens our global presence and positions us for sustained growth in higher-margin segments.”
The Ambernath facility also supports research and development, pilot-scale operations, and contract development and manufacturing (CDMO/CMO) services. The company stated that the site aligns with its goal of evolving into a diversified pharmaceutical business. The certification is part of its strategy focused on regulatory compliance, innovation, and long-term value creation.