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Dr Reddy's to appeal US District Court's decision on sale of generic Buprenorphine and Suboxone film
The company intends to appeal the decision made by the US District Court of New Jersey in a preliminary injunction hearing with respect to further sales and commercialisation of its product in the US.
The drug has been approved by the US Food and Drug Administration (USFDA).
The Levetiracetam in Sodium Chloride Injection brand and generic had US sales of approximately USD 37 million MAT for the most recent twelve months ending in April 2018 according to IMS Health.
The company, without mentioning the contents of the EIR, said the USFDA has maintained OAI status at its API manufacturing plant in Srikakulam.
Indian generic drugmaker Dr Reddy's Laboratories Ltd posted a 38.5 percent slump in quarterly net profit as sales declined due to pricing pressure in the United States, its biggest market.
Most Asian markets were trading higher as solid economic data from the United States and Germany reinforced investors' optimism.
Meanwhile, BSE earlier in the day sought clarification from the company on reports that Dr Reddy's shares fell on the buzz of issues raised in EIR for Duvvada plant.
Dr Reddy's Laboratories today said it has received an establishment inspection report from the US health regulator for its formulation manufacturing facility at Duvvada in Visakhapatnam.
Three days before Dr. Reddy's Laboratories Ltd announced quarterly results this summer, a message circulated to a private WhatsApp group saying the Indian drugmaker would not post good numbers.
The drug major had posted a net profit of Rs 308.9 crore in July-September a year ago, DRL said in a filing to BSE.
The company said it has received an establishment inspection report from FDA for a unit at its Srikakulam formulations facility.
In terms of equity volume, 1.57 lakh shares of the company were traded on BSE and over 17 lakh shares changed hands on NSE during the day.
US District court has issued a judgement in favour to the drug firm, ruling that proposed generic version of Suboxone sublingual film does not infringe the patent of Indivior.
DRL has said a law firm representing a purported investor has filed a class action suit in a USA court against the company and its key executives for alleged violations of American federal securities.
The FDA also found violations of manufacturing standards at Dr Reddy's Laboratories Ltd's drug plant, also in Vizag, during an inspection.