Dr Reddy's Labs Shares Hit 52-Week Low Amid USFDA Concerns Prevail

Shares of Dr Reddy's Laboratories slumped as much as 5.12 per cent today to hit fresh 52-week low of Rs 2,602. Stock exchanges sought clarification from the Hyderabad-based Dr Reddy's Lab with reference to news flashed on ET Now quoting "US FDA finds repeat observations from 2015 warning letter. Failed to maintain complete data to ensure compliance." Dr Reddy's Lab in a clarification to exchanges said: "In this regard, the company has already intimated stock exchanges vide our letter dated March 8, 2017 stating that "The unit of out formulation facility at Duvvada, Vishakhapatnam, by the USFDA has been completed today. We have been issued a Form-483 with 13 observations which we are addressing."

Meanwhile, Dr Reddy's Labs has said that regarding Form 483 observations, the company is preparing a comprehensive response and will submit it to the USFDA within stipulated time.

On March 9, 2017, the shares of Dr Reddy's Labs fell 5 per cent after the company had informed stock exchanges that it was issued a Form 483.

A Form 483 is issued by the FDA when its investigators observe any conditions that in their judgement may constitute violations of the US Food Drug and Cosmetic Act.

Separately, Divis Lab shares plunged as much as 20 per cent to its Rs. 632.55 on Tuesday after the pharma company said that it has received an import alert from the US Food and Drug Administration (USFDA) on the products manufactured at company's unit-II of Visakhapatnam plant in Andhra Pradesh.

As of 1:30 pm, shares of Dr Reddy's Labs traded 4 per cent lower at Rs 2,630. Trading volumes on the counter saw a spike as 1.16 lakh shares changed hands on the BSE compared with an average of 55,000 shares traded daily in the past two weeks.