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| Exchange Disseminated Time | Marksans Pharma Ltd has informed BSE that pursuant to the UK MHRA GMP inspection of the Marksans's Goa plant conducted from November 23, 2015 to November 25, 2015 and subsequent to the Company's response to the UK MHRA observations, the Company has received communication from UK 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.
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.
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. |
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