OneSource Specialty Pharma Limited has announced that its Unit 2 manufacturing facility in Bengaluru has received Good Manufacturing Practices (GMP) certification from ANVISA, the Brazilian Health Regulatory Agency. The certification follows a regulatory inspection conducted in November 2024.
The Unit 2 facility is OneSource’s primary site for the production of biologics, including drug substances, finished injectable products, and Drug Device Combinations (DDCs). The site plays a key role in supporting the company’s global manufacturing capabilities.
With ANVISA certification in place, OneSource can now support customers seeking to register and commercialize their pharmaceutical products in Brazil. This includes the supply of GLP-1-based Drug Device Combinations, such as generic Semaglutide, pending individual product approvals.
Neeraj Sharma, CEO & Managing Director of OneSource, stated, “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. It is a critical milestone for our company as Brazil is one of the biggest markets opening for generic Semaglutide in 2026.”
