UK's Drug Regulator Issues Restricted GMP Certificate to Marksans Pharma

New Delhi: Marksans Pharma on Thursday said UK drug regulator MHRA has issued a 'Restricted GMP Certificate' to its Goa plant following violation of manufacturing norms, although it has been allowed to continue supplying critical products to the country.

The company has received communication from UK's MHRA informing that they are issuing a 'Restricted GMP Certificate' allowing the company to continue manufacture and marketing of critical products for the UK markets, Marksans Pharma said in a BSE filing.

The development is subsequent to the company's response of observations made by UK's MHRA after good manufacturing practice inspection of the Goa plant conducted from November 23, 2015 to November 25, 2015, it added. 

"The restricted GMP status would continue until MHRA's next inspection. Next reinspection can be as early as when the Qualified Person EU (QP) certifies site to be inspection ready. Once reinspected, the same can be reinstated to GMP compliant status," the filing added.

The company further said as per MHRA's assessment, listed products manufactured by Marksans Pharma for the UK market are evaluated to be critical for public health and are allowed continuation of manufacture.

"Marksans Pharma is committed to complete holistic remediation and be inspection ready to be GMP compliant at the earliest," it said. 

Shares of the company closed at Rs 53.95 apiece on the BSE, up 14.06 per cent from the previous close.

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