Dr Reddy's Bachupally facility receives 2 observations from USFDA
On Friday, Dr Reddy Laboratories informed the bourses that the audit for its manufacturing plant at Bachupally (Telangana) was completed by the United States Food and Drug Administration (USFDA). The health regulator issued a Form 483 with two observations to the company.
The company further stated that it would address these observations comprehensively within the stipulated timeline.
Earlier this week, the company launched Naproxen and Esomeprazole Magnesium Delayed-Release Tablets, the therapeutic equivalent of Vimovo Delayed-Release Tablets which have US sales of approximately US$ 414 million for the most recent twelve months ending in December 2019, according to IQVIA Health.
For the recently concluded quarter of December 2019, the company reported consolidated revenue of Rs 4,383 crore as against Rs 3,850 crore in the corresponding quarter last year, registering 13.8 per cent YoY increase. For the quarter ended December 2019, the company reported a net loss of Rs 569.7 crore as against Rs 485.2 crore in the corresponding quarter for the previous fiscal year.
Dr Reddy's Laboratories is a pharmaceutical company that is operating in three segments, namely, global generics, pharmaceutical services and active ingredients and proprietary products. The company's major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.
On Friday the stock closed at Rs 2925.80, down by 4.66 per cent or Rs 142.85 per share. The 52-week high is recorded at Rs 3,363 and the 52-week low is Rs 2,352 on BSE.