Information on the GMP status of Micro Labs Kumbalgodu (ML08) manufacturing facility

A Good Manufacturing Practice (GMP) inspection of Micro Labs Ltd., Kumbalgodu (ML08) was carried out by the World Health Organization 27-31 August 2018. As part of its corrective and preventive action plan and to expand and modernize equipment and systems on site, Micro Labs Ltd., Kumbalgadu notified PQT: Inspections during December 2018 of its decision to undertake extensive renovations and refurbishment of its ML08 facility.

Consequently, the company voluntarily suspended manufacturing of prequalified finished pharmaceutical products at this facility from 12 February 2019 onwards, until completion of the modifications of the facility and completion of its intended corrective and preventive actions following the inspection. Therefore, the continuous manufacturing of any medicines at the site is not acceptable until the completion of the modifications of the facility, as the renovation activities will impact on its ability to comply with the standards of Good Manufacturing Practices (GMP) published by the World Health Organization (WHO).

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