Dr Reddys Laboratories Limited

As per terms, Promius Pharma will be paid upfront and get future royalties as consideration for the cream and its generic in the US

Revenues grew 12% to Rs 37.21 bn due to a healthy 30% growth in domestic sales and a 16% rise in revenue contribution from emerging markets in generics

Analysts on average had expected a net profit of Rs 2.98 billion

These recalled tablets are in the strengths of 10 mg, 20 mg and 40 mg

The restraining order was extended for another 14 days on June 15 during which time the US court will consider the application and issue a ruling on the injunction

Mylan Technologies Inc too has received the FDA nod for the same drug Suboxone (buprenorphine and naloxone) sublingual film in multiple strengths.

The launch follows approval of Melphalan Hydrochloride for Injection, a therapeutic equivalent generic version of Alkeran marketed by Apotex Inc, by the USFDA

The company on Monday, December 11, announced that it has received EIR from the US drug regulator for its facility in Bachupally, Hyderabad following the audit in April

The stock rallied 6% to Rs 2,328 on BSE after the company announced that it has received EIR from the US drug regulator for its facility in Hyderabad following audit in April.

The German regulator will re-inspect the facility by the end of 2018

BS ReporterHyderabad, 21 November: Dr Reddy's Laboratories Limited on Wednesday informed the stock exchanges that the company has received the establishment inspection report(EIR) from the US Food and Drug Administration(USFDA) for its formulations manufacturing facility at Duvvada in Visakhapatnam. But the company was told that the inspection process was not over yet."In the cover letter to the EIR, FDA has explained that the inspection has not closed, and the site's status remains unchanged, but that FDA has released the EIR in order to be transparent about its regulatory process. We are planning to request a reinspection in 2018 after further discussion on scheduling with FDA," Dr Reddy's said in a filing.It may be recalled that in November 2015, the US drug regulator had issued a warning letter against three of Dr Reddy's facilities, including the Duvvada plant, after its inspection teams found compliance issues. Commenting on the development, Sarabjit Kour Nangra of Angel ...