 "FDC gains on completion of USFDA inspection of manufacturing unit")
FDC was trading higher by 6% to Rs 195 on the BSE after the company announced that US Food and Drug Administration (USFDA) has completed inspection at its manufacturing unit situated at Waluj, Maharashtra.
The company has also received the Establishment Inspection Report (EIR) from 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,” FDC said in a BSE filing.
The company has also received the Establishment Inspection Report (EIR) from 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,” FDC said in a BSE filing.
The company said inspection of the company's manufacturing unit situated at Waluj, District- Aurangabad, Maharashtra, by USFDA has been completed on July 01, 2016. The US FDA 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, it added.
The stock hit an intra-day high of Rs 198 on the BSE. The trading volumes on the counter jump an over three-fold with a combined 351,389 shares changed hands till 01:56 PM, against an average sub 100,000 shares that were traded daily in past two weeks on the BSE and NSE.
