Another FDA Import Alert for an Indian Manufacturer due to GMP problems

Recommendation

29/30 March 2023

Improve your Quality Reviews - Live Online Training
PQR, APR, Management Review, Quality Metrics

The FDA has issued an Import Alert for an Indian manufacturer due to serious GMP deviations. Apotex Pharmachem in India Plot No.: 1A, Bommasandra , Industrial Area, 4th Phase , Bangalore was found out of GMP compliance. As a result of the FDA Import Alert no products covered by the Import Alert will be allowed to enter the US market. Just recently Zhejiang Jiuzhou Pharmaceutical and Zhejiang Zonebanne located in China where banned by US FDA.

According to Bloomberg Media the Import Alert covers the company’s drugs and antibiotics, with the exception of riluzole tablets, which treat Lou Gehrig’s disease. It is very likely that EU regulators will quickly verify the FDA findings to make an own decision about the products which - for the time being - can still enter the EU market.

Apotex joins other Indian manufacturers like Ranbaxy, Wockhardt, Sun Pharmacetucial Industries who have failed to establish adequate GMP controls. As a consequence products manufactured by these companies cause a risk for patient safety.

Source: FDA Import Alert