Wanbury Limited has announced that its manufacturing facility in Patalganga, Maharashtra has received the Good Manufacturing Practices (GMP) Certificate from ANVISA, the Brazilian Health Regulatory Agency. The certification confirms compliance with Brazilian regulatory standards for pharmaceutical production.
The GMP certification was granted after ANVISA reviewed the inspection report issued by the USFDA, along with other relevant documentation concerning the Patalganga site. This development follows the earlier certification of Wanbury’s Tanuku facility in Andhra Pradesh, which was reported by the company on May 12, 2025.
With this latest certification, both of Wanbury’s API manufacturing sites—Patalganga and Tanuku—are now in compliance with ANVISA’s regulatory requirements. The certification document was originally issued in Portuguese, and an English translation has been made available.
In the meantime, on May 12, the company completed an inspection by the Brazilian Health Regulatory Agency (ANVISA) at its Tanuku, Andhra Pradesh facility. Conducted from December 16 to 20, 2024, the inspection concluded with zero observations, confirming full compliance with ANVISA’s Current Good Manufacturing Practices (cGMP). As a result, ANVISA has granted the Certificate of Good Manufacturing Practices (CBPF), issued in both English and Portuguese. This certification is essential for exporting pharmaceutical products to Brazil and affirms the facility’s adherence to Brazilian regulatory standards.
