India's OneSource Specialty Pharma Limited has achieved a significant regulatory milestone with its flagship Unit 2 facility in Bengaluru receiving Good Manufacturing Practices (GMP) certification from ANVISA, the Brazilian Health Regulatory Agency. The approval follows a successful regulatory inspection conducted from November 18-22, 2024.
The Bengaluru-based Unit 2 facility specializes in manufacturing high-quality biologics drug substances and finished products, with particular expertise in Drug Device Combinations (DDCs) and injectable formulations. This certification expands OneSource's global regulatory approvals portfolio and positions the company to serve pharmaceutical clients targeting the Brazilian market.
Neeraj Sharma, CEO and Managing Director of OneSource, emphasized the strategic importance of this approval: "We are proud to add ANVISA to the growing list of global regulatory agencies that have approved our flagship facility Unit 2 for its quality, compliance, and technical excellence. This approval now enables OneSource to supply pharmaceutical products specially DDCs, including GLP-1s manufactured at this site to the Brazilian market upon our customers getting their product approvals."
Strategic Market Positioning
The ANVISA certification comes at a pivotal time for OneSource, particularly regarding the GLP-1 receptor agonist market. Sharma noted that "Brazil is one of the biggest markets opening for generic Semaglutide in 2026," highlighting the company's forward-looking approach to capturing market opportunities in the rapidly expanding GLP-1 therapeutics sector.
Semaglutide, marketed under brands like Ozempic and Wegovy, has seen explosive global demand for both diabetes management and weight loss applications. As patent expirations approach, contract development and manufacturing organizations (CDMOs) with appropriate regulatory approvals will be positioned to support pharmaceutical companies entering the generic and biosimilar markets.
Company Background and Capabilities
OneSource Specialty Pharma Limited, formerly known as Stelis Biopharma Limited, identifies itself as India's first specialty pharma pure-play CDMO business. The company operates five state-of-the-art facilities across India, all of which have secured approvals from major global regulatory authorities, including the U.S. Food and Drug Administration (FDA) and European Union regulatory bodies.
The company's manufacturing capabilities span biologics production, including both drug substances and finished formulations, with specialized expertise in complex delivery systems such as Drug Device Combinations. This technical capability is particularly relevant for products like GLP-1 receptor agonists, which are typically administered via injection pens or other specialized delivery devices.
Regulatory Excellence and Global Compliance
The successful ANVISA inspection underscores OneSource's commitment to maintaining rigorous quality standards and regulatory compliance across its manufacturing network. Brazilian regulatory requirements are known to be stringent, with ANVISA following international standards for pharmaceutical manufacturing.
For pharmaceutical companies seeking to enter the Brazilian market, partnering with a CDMO that holds ANVISA certification eliminates a significant regulatory hurdle and can potentially accelerate time-to-market for new products. This is especially valuable in competitive therapeutic areas like the GLP-1 space, where being an early market entrant can provide substantial commercial advantages.
As global demand for complex biologics and specialized delivery systems continues to grow, OneSource's expanded regulatory approvals strengthen its position as a partner for pharmaceutical companies seeking manufacturing capabilities for both innovative and generic products targeting multiple international markets.
