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Wockhardt Facility Meets GMP Standards, MHRA Says

Dec. 28, 2016

The UK’s Medicines and Healthcare Products Regulatory Agency awarded Wockhardt’s Maharashtra, India facility a GMP certificate for passing inspection requirements.

The certificate is based on a November inspection that resulted in no critical observations. The plant, which makes generic drugs and antibiotics, has fallen under criticism in the past, facing bans on exports from UK regulators and the FDA.

Earlier this year, the FDA expanded its ban to include all APIs produced at the facility, and the agency banned imports from a third Wockhardt plant in October. A Wockhardt subsidiary — CP Pharmaceuticals — recently received a warning letter for GMP violations.

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