Synthimed has successfully accomplished cGMP inspection of ANVISA Brazil at our Derabassi facility
Synthimed is pleased to announce the successful completion of a cGMP (current Good Manufacturing Practice) inspection conducted by ANVISA Brazil at our Derabassi facility on June 14, 2024. The inspection concluded “without any observation,” marking a significant milestone for the company.
This rigorous inspection was performed by ANVISA (Agência Nacional de Vigilância Sanitária – National Health Surveillance Agency) in connection with Synthimed’s CADIFA (Certificate of Good Manufacturing Practices for Active Pharmaceutical Ingredients) applications for several key products:
- Atorvastatin Calcium
- Clarithromycin
- Lisdexamfetamine Dimesylate
- Fexofenadine Hydrochloride
- Ezetimibe
The successful outcome of this inspection demonstrates Synthimed’s unwavering commitment to maintaining the highest standards of quality and compliance in pharmaceutical manufacturing.
Looking ahead, once ANVISA publishes the GMP certification and approves the CADIFA applications, Synthimed’s customers will be able to proceed with launching their formulations containing these active pharmaceutical ingredients in the Brazilian market.