• Regulatory NewsRegulatory News

    FDA Finds Quality Documents Stuck in a Shredder at Glenmark Facility

    The US Food and Drug Administration (FDA) on Tuesday released a heavily redacted Form 483 sent last month to Glenmark Pharmaceuticals' Solan, India-based manufacturing facility. One of the seven observations in the Form 483, first announced by the company on 28 November , noted that FDA inspectors found at least 13 quality documents "shredded in the teeth and surrounding internal moving parts of the shredder." FDA said the quality documents were not listed on the ...
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    FDA Form 483s From India: A Deep Dive Into the Problems

    Untitled Document A Focus review (thanks to the Freedom of Information Act) of 50 Form 483s issued by the US Food and Drug Administration (FDA) to Indian pharmaceutical and active pharmaceutical ingredient (API) manufacturers over the past two years reveals a slew of detailed quality concerns from the agency. And although the products described in the 483s have been redacted, and a majority of the FDA observations are for relatively commonplace documentatio...
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    Indian Court Sides with Merck in Patent Dispute

    A prominent court in India has issued an interim injunction, overturning a previous ruling, in favor of US drug maker Merck in a patent dispute with Glenmark Pharmaceuticals over an active ingredient used in two of Merck's diabetes medicines, Januvia and Janumet. Background India’s patent system has been a source of frustration for western drug makers, which have argued for intellectual property (IP) reform in the country. While there have been several high-profile ...