Univar unveils new certification with disinfectant product
A disinfectant used in the pharmaceutical sector and in oral and skin care has gained new certification aimed at simplifying regulatory demands.
Chlorohexidine Gluconate, which is manufactured by R N Pharmaceuticals, gained the Certificate of Suitability (CEP) under the European Directorate for the Quality of Medicines (EDQM).
The new certification means that businesses using this chemical compound can forgo the onerous task of supplying all the specific information about the product.
The certification confirms compliance of a material with the requirements stipulated in the relevant monograph of the European Pharmacopoeia. The CEP was issued in July 2008 and confirms the GMP quality standard under which the product is manufactured and supplied. There is also a Drug Master File (DMF) available.
R N Pharmaceuticals has invested over US$10m in its manufacturing facilities in recent years and has opened a new state-of-the-art facility, which increases production capacity to 3,000 tonnes.
The disinfectant is distributed through Univar Pharma Ingredients – the global brand of Belgium-based Univar to the pharmaceutical raw material market.
‘We look forward to continuing to develop the Chlorohexidine Gluconate market in Europe in partnership with RN Pharmaceuticals,’ said Roger Chantillon, Univar’s European industry director. ‘The CEP is a big step forward because customers now have the independent assurance of the quality of the product. The CEP for Chlorohexidine Gluconate delivers the answers they need to simplify regulatory demands’.
R N Pharmaceuticals managing director Rohit Garg, said: ‘The investment we have made in new facilities and in obtaining the CEP demonstrates our commitment to be a global leader in Chlorohexidine manufacture. With the CEP and the continuing partnership with Univar we are excited about the prospects for expanding the market in Europe.’