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Indoco Remedies receives non-compliance statement form UK-MHRA

At the end of the preapproval inspection, the US regulator issued four observations in Form 483.

Indoco Remedies has received statement for non compliance and restricted GMP certificate, to allow continued manufacture and testing of products considered to be medically critical or to ensure continuity of supply, from UK-MHRA.

In March 2018, UK drug regulatory, UK-MHRA issued 3 critical and 4 major observations were at its Goa drug manufacturing facility (Goa-Plant I). The company stated that, the MHRA statement said, there is no evidence of product having been impacted and therefore the inspectorate does not recommend that the products are recalled.

Furthermore, the company is in talks with the European Health authorities and are hopeful of getting an early resolution. Meanwhile, medically critical products will be allowed to be supplied from the affected facility, the list of which is being finalized by MHRA and other National Competent authorities in coordination with our customers.

Read EquityPandit’s Technical Analysis of Nifty Pharma

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