Shilpa Hit With FDA Warning Letter
Company’s Jadcherla Facility Is Under Watch
India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.
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The FDA has revealed details of its recent warning letter to Shilpa, which cites the company’s failure to adequately investigate out-of-specification results and complaints as well as to follow written procedures for complaint handling.
Apart from acquiring FTF Pharma and Auxilla, India’s Shilpa Medicare has ramped up its manufacturing to cater to the global market. Having recently launched a new product, the company is feeding its pipeline to ensure that it can keep its growth momentum going.
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