The receipt of EIR indicated closure of the audit of the Bollaram facility
The Nifty might have turned negative for 2019, but almost 60% of index constituents are in a bear grip as registered by the 'Death Cross' formation
The company has launched Lansoprazole delayed-release capsules USP in the strength of 15 mg in the US market, as approved by the United States Food and Drug Administration (USFDA), Dr Reddy's said in a BSE filing.
According to a release by the city-based drug maker, the generic Zyban has been approved by the U.S. Food and Drug Administration.
The company's biosimilar, Versavo, is available in strengths of 100 mg and 400 mg single use vials, Dr Reddy's said in a statement.
The USFDA sends the applicant a CRL if the agency determines that it will not approve the application, or ANDA, in its present form for one or more reason
Global brokerage Citi slashed price target to Rs 2,375 from Rs 2,540 per share, citing likely more delay in female contraceptive drug launch after fresh Complete Response Letter from US FDA.
The audit of our formulations manufacturing facility at Shreveport, Louisiana, USA by the the US Food and Drug Administration (USFDA), has been completed on August 8, 2019.
Prabhudas Lilladher recommended accumulate rating on Dr. Reddy's Laboratories with a target price of Rs 2997 in its research report dated July 29, 2019.
The product is a generic version of C P Pharmaceuticals International C V's Lyrica capsules which had US sales of around $5,462 million for the twelve months ended May 2019.
CLSA maintained its buy rating on Dr Reddy’s and also stressed on the fact that the company is on track to deliver on its realigned strategy.
The tablets are indicated for the treatment of insomnia characterised by difficulty with sleep onset.
Earlier in June 2019 Dr Reddy's had said in a regulatory filing that it had entered into a definitive asset purchase agreement with Upsher-Smith Laboratories LLC to sell its US and select territory rights for the two products to the latter.
Net Sales are expected to increase by 2.2 percent Y-o-Y (down 5.2 percent Q-o-Q) to Rs. 3,820.3 crore, according to Prabhudas Lilladher.
Shares of Dr Reddy's Labs were trading at Rs 2,590 per scrip on BSE, down 1.46% from the previous close.
Dr Reddy's Srikakulam unit has received a clearance letter from Greek drug regulator, reported CNBC-TV18
Dr Reddy's Labs will commercialise these products through its wholly owned subsidiary, Promius Pharma, LLC.
The company would continue to focus on R&D for some interesting pipeline of proprietary products.
Narnolia Financial Advisors expects the pharma company to report a net profit of Rs 545 crore as against Rs 500 crore in the last quarter
The company has launched its product, which is generic version of Merck Sharp & Dohme Corp's Cubicin, after obtaining approval from the US Food and Drug Administration (USFDA), the Hyderabad-based firm said in a statement.
The company's testosterone gel 1.62 percent is a therapeutic equivalent generic version of AndroGel 1.62 percent of AbbVie Inc.
Dr Reddy's Laboratories Inc, a subsidiary of the Hyderabad-based Dr Reddy's Laboratories, is voluntarily recalling the affected lot of bottles on account of certain deviations from the Current Good Manufacturing Practice (CGMP) regulations.