Wanbury has recently informed exchanges that its Tanuku plant in Andhra Pradesh has successfully completed a 4-day inspection by ANVISA, the Brazilian Health Regulatory Agency, from December 16 to 19, 2024.
The inspection, conducted at the company’s API (Active Pharmaceutical Ingredient) manufacturing facility, concluded with zero observations, confirming strict adherence to cGMP (current Good Manufacturing Practices) standards.
This achievement highlights Wanbury’s commitment to quality and regulatory compliance. As a result, the company will receive a GMP (Good Manufacturing Practice) compliance certificate, enhancing its ability to expand its global business. ANVISA’s certification, part of the Pharmaceutical Inspection Convention (PIC), is crucial for market access in Brazil and beyond.
This marks Wanbury’s second international FDA inspection in 2024 with zero observations, following a similar success at its Patalganga plant in June. Wanbury is a leading manufacturer of Metformin HCl and Sertraline API, with additional APIs nearing production.
This successful ANVISA inspection underscores Wanbury’s ongoing dedication to producing high-quality APIs in line with international standards, supporting global growth and business opportunities.
