FDC gains after announcing completion of USFDA inspection

FDC rose 6.29% to Rs 196 at 12:25 IST on BSE after the company announced that inspection at its manufacturing unit situated at Waluj, Maharashtra, by US FDA has been completed.

The announcement was made on Saturday, 2 July 2016.

Meanwhile, the S&P BSE Sensex was up 236.03 points or 0.87% at 27,380.94

On BSE, so far 55,000 shares were traded in the counter as against average daily volume of 4,796 shares in the past one quarter. The stock hit a high of Rs 197.50 and a low of Rs 184.30 so far during the day. The stock had hit a 52-week high of Rs 273.80 on 6 October 2015. The stock had hit a 52-week low of Rs 152 on 2 July 2015. The stock had outperformed the market over the past 30 days till 1 July 2016, rising 1.77% compared with 1.12% rise in the Sensex. The scrip, however, underperformed the market in past one quarter, gaining 2.22% as against Sensex's 7.42% rise.

The mid-cap company has equity capital of Rs 17.78 crore. Face value per share is Re 1.

FDC said that inspection of the company's manufacturing unit situated at Waluj, Maharashtra, by US Food and Drug Administration (USFDA) has been completed on 1 July 2016. The USFDA has made two minor observations for which appropriate steps shall be taken by the company, FDC said. The audit was carried out in relation to current good manufacturing practice (cGMP) inspection and abbreviated new drug application (ANDA) filed by the company for product Dorzolamide Ophthalmic Solution. FDC said that 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 company said. The audit was carried out in relation to cGMP inspection and ANDA filed by the company for product Cefixime 400 mg tablet, it added.

FDC's net profit rose 12.9% to Rs 38.25 crore on 10.9% growth in net sales to Rs 238.90 crore in Q4 March 2016 over Q4 March 2015.

FDC is a pharmaceutical research and development company, which specializes in the areas of synthetics (basic drugs), nutraceuticals, formulations and biotechnology products.

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