Natco gets USFDA observation on 2 units

An inspection was conducted by the USFDA in two of its facilities recently — the Active Pharmaceutical Ingredients (API) manufacturing facility at Manali, near Chennai, and the Pharmaceutical Formulations facility at Kothur, near Hyderabad, in early February and March.

As the Indian generic drug and API industries continue to be one of the main suppliers to the US, USFDA’s presence in the India is important for ensuring the products are safe and effective.

There are many received the 483 observation include: Aarti, Akorn India, Wintac, Ajanta Pharma, Agila Specialties, Apotex, Aurobindo, Cadila, Claris Injectables, Cipla, Emcure Pharmaceuticals, Glenmark Generics, Hetero, Indoco Remedies, Ipca Laboratories, Lupin, MegaFine Pharma, Nosch Labs, Pan Drugs, Shlipa Medicare,  Sri Krishna Pharmaceuticals, and many more.