EDQM approves Unichem's Roha manufacturing unit

Mumbai, Jun 23, 2008 (Asia Pulse Data Source via COMTEX) -- UICLF | Quote | Chart | News | PowerRating -- Pharma major Unichem Laboratories has received a certification from the European Directorate for the Quality of Medicines and Healthcare for its active pharmaceutical ingredients plant in Roha, Maharashtra.

This certificate was issued for compliance as per European Union (EU) guidelines on Good Manufacturing Practice (GMP) for active substances used as starting materials, a company statement said here.

The Roha plant was already approved by United States Food Drug Administration (USFDA) and TGA (Australia), the statement added.

Currently, the plant manufactures a wide range of drug substances including like hydrochlorothiazide, amlodipine besilate, metronidazole, bendroflumethiazide bisoprolol fumarate, meloxicam, amlodipine maleate, clonidine HCl and Tizanidine HCl.

Unichem's Active Substances [bulk drugs] plant in Roha was set up in the year 1976 and has undergone substantial expansion and modernisation from time to time.

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