OneSource Pharma Gains Brazilian Approval for Manufacturing Excellence

OneSource Specialty Pharma announced its Unit 2 in Bengaluru received GMP certification from Brazil's ANVISA, marking a key achievement in quality and compliance. This enables the company to supply Brazilian markets with products, including DDCs and GLP-1s. Brazil's market opens for generic Semaglutide in 2026.

OneSource Specialty Pharma revealed on Thursday that its flagship unit in Bengaluru has achieved a significant milestone by securing Good Manufacturing Practices (GMP) certification from Brazil's ANVISA.

This accreditation enables OneSource to penetrate the Brazilian market with its high-quality Biologics, including drug device combinations and injectable products. The approval follows a successful inspection conducted in November 2024.

CEO & Managing Director Neeraj Sharma highlighted that Brazil presents immense market opportunities, particularly as it gears up to introduce generic Semaglutide by 2026. The company's rebranding from Stelis Biopharma Ltd underscores its commitment to quality and regulatory compliance.

(With inputs from agencies.)