Dr Reddy's Lab slips after submitting response to USFDA over warning letter

Dr Reddy's Laboratories fell 2.79% to Rs 2,985.05 at 9:23 IST on BSE after the company said it has submitted a response to the US health regulator on a warning letter it had received last month.

The announcement was made after market hours yesterday, 8 December 2015.

Meanwhile, the BSE Sensex was down 56.65 points, or 0.22%, to 25,253.68.

On BSE, so far 22,000 shares were traded in the counter, compared with an average volume of 62,384 shares in the past one quarter.

The stock hit a high of Rs 3,006 and a low of Rs 2,953.35 so far during the day. The stock hit a record high of Rs 4,382.95 on 20 October 2015. The stock hit a 52-week low of Rs 2,953.35 on 9 December 2015.

The stock had underperformed the market over the past one month till 7 December 2015, sliding 12.37% compared with 2.80% decline in the Sensex. The scrip had also underperformed the market in past one quarter, falling 19.47% as against Sensex's 2.56% rise.

The large-cap company has an equity capital of Rs 85.30 crore. Face value per share is Rs 5.

Dr Reddy's Laboratories (DRL) said that it has submitted its response to the United States Food and Drug Administration (USFDA) on 7 December 2015. It may be recalled that the USFDA in its warning letter issued to the company dated 5 November 2015, identified significant deviations from current good manufacturing practice (CGMP) at DRL's two pharmaceutical manufacturing facilities in Andhra Pradesh and a unit in Telangana.

The company did not disclose the details of its response.

USFDA had asked the drug maker to provide a comprehensive evaluation of the extent of inaccuracies in recorded and reported data and include a detailed action plan to fully investigate the scale and root causes of deficient documentation and data management practices.

Dr Reddy's Laboratories' consolidated net profit rose 25.7% to Rs 721.89 crore on 11.2% growth in net sales to Rs 3988.96 crore in Q2 September 2015 over Q2 September 2014.

Dr Reddy's Laboratories is an integrated global pharmaceutical company. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products - Dr Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

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