OneSource Specialty Pharma 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 approval follows a successful regulatory inspection conducted in November 2024.
The certification permits OneSource to expand its reach into Brazil, supporting clients preparing for product registration and market entry. Unit 2 is the company’s flagship site and is dedicated to the manufacture of biologics drug substance and finished products, including drug-device combinations (DDCs) and injectable formulations.
Neeraj Sharma, CEO and Managing Director of OneSource, said: “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.”
The ANVISA GMP clearance further expands OneSource’s regulatory footprint, enabling the company to support clients targeting regulated international markets.