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Dr Reddys Laboratories Ltd Monday announced it has received the approval of the US Food and Drug Administration to market aspirin and dipyridamole capsules in the USA.
This divestiture is being done by way of slump sale (as a going concern) and includes all related fixed assets (land and building), current assets, current liabilities, and its employees.
The recall is on account of "failed stability specifications - an out of specification result was observed for the test parameter: composition of Nystatin during stability testing," it added.
The vials were manufactured by Gland Pharma for Dr Reddy's Laboratories, the Enforcement Report said.
Hervycta (Trastuzumab), a biosimilar of Roche's Herceptin in India, is used for treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer).
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.
The FDA also found violations of manufacturing standards at Dr Reddy's Laboratories Ltd's drug plant, also in Vizag, during an inspection.
A notification by the FDA said recalls are voluntarily initiated by the two companies.