Dr Reddy's Labs slips after getting Form 483 for API Hyderabad plant 1

Dr Reddy's Laboratories fell 1.34% to Rs 2,154 at 15:23 IST on BSE after the company said its API Hyderabad Plant 1 received Form 483 with four observations following an audit by the US drug regulator.

The announcement was made during market hours today, 16 March 2018

Meanwhile, the S&P BSE Sensex was down 466.74 points, or 1.39% to 33,218.80.

On the BSE, 34,000 shares were traded in the counter so far compared with average daily volumes of 26,000 shares in the past two weeks. The stock had hit a high of Rs 2,207.75 and a low of Rs 2,119.70 so far during the day. The stock hit a 52-week high of Rs 2,788 on 24 July 2017. The stock hit a 52-week low of Rs 1,901.65 on 11 August 2017.

Dr Reddy's Laboratories announced that the audit of its API Hyderabad Plant 1 at Jinnaram Mandal, Medak District, Telangana by the US Food and Drug Administration (USFDA) completed today, 16 March 2018. The unit has been issued a Form 483 with four observations which will be addressed comprehensively within stipulated time.

In a separate announcement during market hours today, 16 March 2018, Dr. Reddy's Laboratories said that it has launched Levocetirizine Dihydrochloride tablets USP, 5 mg, an over-the-counter therapeutic equivalent generic version of Xyzal Allergy 24HR tablets in the United States market as approved by the US Food and Drug Administration (USFDA).

The drug is an over-the-counter antihistamine used for 24-hour relief of allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. The Xyzal Allergy 24HR Tablets brand had US sales of approximately $71 million for the most recent twelve months ending in January 2018 according to IRI.

Dr. Reddy's Levocetirizine Dihydrochloride tablets USP is available in 5 mg strength and in various consumer oriented package sizes.

Dr Reddy's Laboratories' consolidated net profit fell 38.5% to Rs 302.70 crore on 2.7% growth in net sales to Rs 3806 crore in Q3 December 2017 over Q3 December 2016.

Dr Reddy's Laboratories is an integrated global pharmaceutical company.

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