FDC has received the Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for its manufacturing unit situated at Baddi, Himachal Pradesh with ‘No observations’. This approval confirms the closure of inspection conducted in February 2016. The said audit was carried out in relation to cGMP inspection and ANDA filed by the company for product Cefixime 400 mg tablet.
Besides, there was an inspection at the company’s manufacturing unit situated at Waluj, Aurangabad district in Maharashtra, by USFDA which has been completed on July 01, 2016. The USFDA has made two minor observations for which appropriate steps shall be taken by the company. The above audit was carried out in relation to cGMP inspection and ANDA filed by the company for product Dorzolamide Ophthalmic Solution.
FDC is an India-based pharmaceutical company engaged in pharmaceutical business. The company manufactures Electral, oral rehydration salt (ORS), being a leader in this segment.
