OneSource Gets Brazil Approval for Flagship Facility
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OneSource Specialty Pharma's Unit 2 in Bengaluru receives GMP certification from ANVISA, enabling the company to supply pharmaceutical products, including GLP-1s, to the Brazilian market.
Photograph: Yves Herman/Reuters
New Delhi, Apr 10 (PTI) OneSource Specialty Pharma on Thursday said its flagship unit has received approval from the Brazillian health authority ANVISA.
The company's Unit 2 facility in Bengaluru has been granted Good Manufacturing Practices (GMP) certification by ANVISA, the Brazilian Health Regulatory Agency, following a successful regulatory inspection held in November 2024, the drug firm said in a statement.
The approval marks a significant milestone in OneSource's ongoing commitment to quality and regulatory compliance, it added.
Unit 2 is OneSource's flagship site dedicated to manufacturing high quality Biologics drug substance and finished products, including drug device combinations (DDC) and other injectable products.
"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," Neeraj Sharma, CEO & Managing Director of OneSource said.
It is a critical milestone for the company as Brazil is one of the biggest markets opening for generic Semaglutide in 2026, he added.
OneSource Specialty Pharma, formerly known as Stelis Biopharma Ltd), is a specialty pharma contract development and manufacturing organisation (CDMO).
The company's Unit 2 facility in Bengaluru has been granted Good Manufacturing Practices (GMP) certification by ANVISA, the Brazilian Health Regulatory Agency, following a successful regulatory inspection held in November 2024, the drug firm said in a statement.
The approval marks a significant milestone in OneSource's ongoing commitment to quality and regulatory compliance, it added.
Unit 2 is OneSource's flagship site dedicated to manufacturing high quality Biologics drug substance and finished products, including drug device combinations (DDC) and other injectable products.
"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," Neeraj Sharma, CEO & Managing Director of OneSource said.
It is a critical milestone for the company as Brazil is one of the biggest markets opening for generic Semaglutide in 2026, he added.
OneSource Specialty Pharma, formerly known as Stelis Biopharma Ltd), is a specialty pharma contract development and manufacturing organisation (CDMO).
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