Reportedly the US Food and Drug Administration (FDA) has raised doubts about Strides Pharma Sciences Ltd’s quality control practices after finding adulteration and evidence of uncontrolled shredding of documents at one of its plants. Meanwhile the FDA found "significant violations" of current good manufacturing practice (CGMP) regulations at Strides Pharma's plant in puducherry in southern india, the drug regulator said in a warning letter that was made public on Tuesday.
Furthermore shares of the Bangalore-based company, which fell as much as 8 per cent to a near one year low earlier on Wednesday, were trading down 3.2 per cent at 1:27 pm. Previously Aurobindo Pharma Ltd was warned by the FDA for ignoring impurities in an active ingredient it produced. hyderabad-based Aurobindo recalled contaminated valsartan in January and in March.
Moreover the destruction of quality-control paperwork by Strides and a lack of adequate documentation that its medicines are safe raise questions about the effectiveness of Strides’s quality unit and the integrity and accuracy of its data, said Francis Godwin, director of the FDA’s Office of Manufacturing Quality, in the letter. Apparently CGMP documents in the binder were dated as recently as January 21, 2019: seven days before our inspection. Your quality unit did not review or check these documents prior to disposal, Godwin said in the letter, addressed to Strides Chief Executive Officer Arun Kumar.
President Trump likely to hear from PM Modi about plans for human rights in Kashmir Reportedly the Unites States said India’s decision on Article 370 for the state of Jammu and Kashmir is an internal matter but has regional implications and President Donald Trump expects to hear from PM Narendra Modi when they meet on the margins of the upcoming G-7 meetings what he plans to do to reduce
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