J.B. Chemicals & Pharmaceuticals Limited (JBCPL) has been awarded the "Certificate of Suitability to European Pharmacopoeia Monograph" or "EP4" by the European Union (EU) for its Active Pharmaceutical Ingredients (API), metronidazole and diclofenac sodium.

Metronidazole is currently being exported to the USA, Germany, Italy, Netherlands and Iran, and sales for 2001-02 amounted to approximately Rs seven crore. The Company's metronidazole manufacturing plant at Ankleshwar, Gujarat, already has US FDA and TGA Australia approval.

Exports of diclofenac sodium constituted 39 per cent of the drug's sales of Rs. 18 crore, and seven per cent of JBCPL's total sales amounting to Rs. 276 crore in 2001-02. JBCPL currently exports diclofenac sodium to Germany, Mexico, Italy and Iran.

JBCPL is one of the first companies in India and across Asia to obtain the prestigious new EP4 European Certification, which was recently upgraded from the earlier "European Pharmacopoeia Certification" to a higher quality standard, i.e. "European Pharmacopoeia 2002" or "EP4". In June 2002, the Company was awarded EP4 certification for its other API, nifedipine.

Dr. Milind Joshi, Corporate Manager said, "In keeping with the latest EU quality standards i.e. EP4 norms, we too have upgraded our quality standards to comply with these new norms. JBCPL exports the above three APIs to a number of reputed pharmaceutical companies in Europe as well as in USA. Obtaining EP4 Suitability Certification will help us to increase exports and consolidate our presence in the quality conscious and strictly regulated European markets."

The Company currently three holds Drug Master Files with the US FDA for metronidazole, diclofenac and nifedipine.