Shilpa Pharma Clears ANVISA Hurdle with Flying Colors—Unit-I Passes Brazil GMP Audit

Shilpa Medicare Ltd has announced a major regulatory milestone: its wholly owned subsidiary, Shilpa Pharma Lifesciences Ltd (Unit-I) has successfully completed a Good Manufacturing Practice (GMP) inspection by ANVISA, Brazil’s national health surveillance agency. The inspection, conducted from June 30 to July 4, 2025, concluded with no critical or major observations, reinforcing the company’s global compliance credentials.

 

Key Highlights:

 

- Clean Inspection Record: The audit ended with only minor procedural observations, which were discussed during the inspection. Shilpa will submit a Corrective and Preventive Action (CAPA) plan within the stipulated timeframe.

 

- Regulatory Significance: ANVISA approval is crucial for accessing Brazil and other Latin American markets. This successful inspection strengthens Shilpa’s foothold in regulated emerging markets.

 

- Facility Profile: Unit-I is part of Shilpa’s expanding API and oncology manufacturing infrastructure, equipped with state-of-the-art isolator technology and designed to meet stringent global standards.

 

- Strategic Impact: The clearance supports Shilpa’s broader strategy to scale exports, especially in oncology and high-potency APIs, and aligns with its recent milestones in USFDA and EU GMP inspections.

 

- Commitment to Quality: The company reiterated its dedication to regulatory excellence, stating that the outcome reflects its robust quality management systems and global manufacturing capabilities.

 

This regulatory green light not only boosts Shilpa’s credibility in international markets but also sets the stage for accelerated growth in Brazil’s high-value pharma segment.

 

Source: Business Upturn, PharmaOffer, Indian Pharma Post