Sun Pharma tumbles after receiving warning letter from USFDA

Sun Pharmaceutical Industries slumped 6.25% to Rs 741.05 at 9:18 IST on BSE after the company said it has received a warning letter from the US drug regulator for its facility located at Halol in Gujarat, as a result of the September 2014 inspection.

The announcement was made on Saturday, 19 December 2015.

Meanwhile, the S&P BSE Sensex was down 23.86 points or 0.09% at 25,495.36.

On BSE, so far 1.44 lakh shares were traded in the counter as against average daily volume of 3.31 lakh shares in the past one quarter.

The stock hit a high of Rs 744 and a low of Rs 732 so far during the day. The stock had hit a 52-week low of Rs 706.40 on 24 November 2015. The stock had hit a record high of Rs 1,200.70 on 7 April 2015.

The stock had outperformed the market over the past one month till 18 December 2015, gaining 4.84% compared with Sensex's 0.14% rise. The scrip had, however, underperformed the market in past one quarter, sliding 12.67% as against Sensex's 2.67% fall.

The large-cap company has equity capital of Rs 240.67 crore. Face value per share is Re 1.

Sun Pharmaceutical Industries (Sun Pharma) said it has responded to the United States Food and Drug Administration (USFDA) inspection observations with a robust remediation process that is still on-going, with significant investments in automation and training to enhance its quality systems. Sun Pharma has been working with external consultants to ensure its remediation activities have been completed in an appropriate manner, the company said in a statement. Post September 2014 inspection, the USFDA has withheld future product approvals from the Halol facility. This situation may continue until all issues are resolved, Sun Pharma said. The company expects to request a re-inspection by USFDA upon completion of its remediation commitments. Sun Pharma and the Halol facility will continue to supply important drug products to meet its obligations to its customers and the patients who use its drugs in the United States and around the world, the company said. Sun Pharma will respond to this warning letter with a detailed plan within the stipulated time frame, the company said in a statement.

Sun Pharmaceutical Industries' consolidated net profit fell 46% to Rs 1106.66 crore on 14.7% decline in net sales to Rs 6803.31 crore in Q2 September 2015 over Q2 September 2014.

Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

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