Indoco Remedies turns volatile after receiving USFDA observations

Indoco Remedies was up 3.13% to Rs 331.35 at 14:18 IST on BSE after the company said that the US drug regulator issued six 483 observations after inspection at the company's Goa plant.

The announcement was made during trading hours today, 7 September 2016. Shares tumbled after this announcement. However, shares bounced back as the company added that all the observations are correctable and the company expects to complete the corrective and preventive actions within a period of 30 days.

Meanwhile, the BSE Sensex was up 18.87 points, or 0.07%, to 28,996.89.

On BSE, so far 1.29 lakh shares were traded in the counter, compared with average daily volume of 6,341 shares in the past one quarter. Trading in the counter was volatile. The stock rose 12.15% at the day's high of Rs 360.35 so far during the day,which is also a 52-week high for the counter. The stock fell 7.53% at the day's low of Rs 297.10 so far during the day. The stock hit a 52-week low of Rs 244 on 25 February 2016. The stock had outperformed the market over the past 30 days till 6 September 2016, rising 3.31% compared with 2.82% rise in the Sensex. The scrip had also outperformed the market in past one quarter, rising 13.47% as against Sensex's 7.24% rise.

The small-cap company has equity capital of Rs 18.43 crore. Face value per share is Rs 2.

Indoco Remedies said that US Food and Drug Administration (USFDA) inspected the company's Goa plant II from 31 August 2016 to 4 September 2016. The injectable Abbreviated New Drug Application (ANDA) filings triggered this inspection.

At the end of the inspection, six 483 observations were issued. All the observations are correctable and the company expects to complete the corrective and preventive actions within a period of 30 days. None of the 483s are related to data integrity issue, the company said.

An FDA Form 483 is issued to a firm at the conclusion of an inspection when an investigator has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Net profit of Indoco Remedies declined 4.95% to Rs 19.79 crore on 15.79% rise in net sales to Rs 252.72 crore in Q1 June 2016 over Q1 June 2015.

Indoco Remedies is a fully integrated, research-oriented pharma vompany with presence in 55 countries.

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