facilityHyderabad, Oct 29 (PTI) A German government's drugregulating agency, which audited one of Dr Reddy'sLaboratories manufacturing facilities here, found "dirty roomsand equipment", among other violations, during an inspection.
According to the inspection report by CentralAuthority for Supervision of Medicinal Products in Bavaria(GMP/GCP) of the Upper Bavarian government, the inspection wasconducted on August 1 at the drug maker's formulationmanufacturing unit-2 at Bachupally.
"Major deficiencies: (only examples are given forsub-items related to 5 major deficiencies)...3. cleaning ofrooms and equipment. (9 sub-items) 3.1 dirty rooms andequipment 3.2 integrity of cleaning-documentation 3.3cleaning-status labeling 3.4 status-label 'clean' of uncleanedequipment 3.5 dedicated-equipment labeling 4. validation ofmanufacturing process. (4 sub-items)...," the regulator saidas nature of non-compliance in its report.
The drug-maker's German subsidiary betapharmArzneimittel GmbH had received a communication from theRegulatory Authority of Germany (Regierung von Oberbayern) inAugust that the regulator had not renewed GMP (goodmanufacturing practice) compliance certificate of itsformulations manufacturing following an inspection.
"Pending revocation of the non-compliancecertification, the plant will not be able to make any furtherdispatches to European Union until the next inspection, to beinitiated by an invitation from Betapharm," Dr Reddy's hadearlier informed.
Dr Reddy's Global Generics segment's revenues fromEurope are primarily derived from Germany, the United Kingdomand out-licensing business across Europe. It clocked Rs 207.5crore revenues from the region for the three months ended June30, 2017, an increase of 28 per cent as compared to the threemonths ended June 30, 2016.
The increase was primarily on account of the increasein sales volume of existing products along with new productslaunched between July 1, 2016 and June 30, 2017, the companyhad said in filing with US Securities and Exchange Commission.
When contacted, a company spokesperson refused tocomment on the impact of the revenues from Europe followingthe German regulator's comments.
The official said they are in "silent period" pendingresults announcement and hence cannot comment.
DRL is slated to announce its July-September quarterresults on October 31.
Regierung von Oberbayern also concluded an audit ofthe company's formulations manufacturing facility in Duvvada,Vishakapatnam, with zero critical and six major observationsrecently. The products manufactured at the facility are notcurrently exported to the EU.
The Duvvada-facility's compliance with the correctiveand preventive action plan and other applicable regulationswill be reviewed again by the regulator by November 2018 forcontinuation of the facility's EU-GMP certification, DrReddy's had said. PTI GDKGK.
This is unedited, unformatted feed from the Press Trust of India wire.