Wednesday, January 9, 2008

JB Chemicals receives German quality accreditation for Panoli unit

JB Chemicals & Pharmaceuticals Ltd has announced that the Unique Pharmaceutical Laboratories (a division of J B Chemicals & Pharmaceuticals Ltd) has received international quality accreditation for their pharmaceutical manufacturing facility at Panoli, Gujarat.

The said facility received the GMP approval from the regulatory authority of Germany which is full member of the Council of European Union.

The inspectors from Regierung Von Obernbayern, the German regulatory authority, inspected the oral dosage forms like tablets and coated tablets, the premises, the equipments, the total quality management systems and the quality control at the facility and certified that it complies with the current regulations as per EG-GMP (European Guidelines for GMP).

The state-of-the-art facility to manufacture tablets is situated at GIDC, Panoli, Gujarat and has received significant approvals from other reputed international regulatory authorities like the US FDA; MCC, South Africa; TGA, Australia and UK MHRA.

This approval would help the company in consolidating its exports to European countries. The approval received after German inspection will be recognized throughout the European Union through the Mutual Recognition between the EU countries. This is a firm step ahead for JBCPL to get more and more site variation projects from the EU Marketing Authorisation holders for generic, prescription as well as OTC products.

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