Univar Launches Chlorohexidine Gluconate with Certificate of Suitability (CEP)
30 September 2008
Frankfurt, Germany, 30 September 2008 – Today at the CPhI Worldwide Pharmaceutical Ingredients event, Univar, one of the world's leading chemical distributors, announced the launch of Chlorohexidine Gluconate (manufactured by R.N. PHARMACEUTICALS) fully certified by the European Directorate for the Quality of Medicines (EDQM). The EDQM's Certificate of Suitability certifies compliance of a material with the requirements stipulated in the relevant monograph of the European Pharmacopoeia. The CEP for Chlorohexidine Gluconate was issued in July 2008. There is also an Active Sustance Master File (ASMF) available.
Chlorohexidine Gluconate is an important disinfectant and antiseptic used in oral care, skin care, cosmetics and pharmaceutical products, commonly used in mouth washes, surgical scrubs, hand washes and teat dips. It is a highly effective preservative in cosmetic preparations. As demands for improved hygiene increase, volumes continue to grow in Europe as well as globally.
Many Chlorohexidine products, especially those with pharmaceutical uses, are licensed by regulatory authorities so an assurance of quality for the raw material is imperative. The CEP demonstrates that Chlorohexidine Gluconate can be supplied to customers with the full assurance that it meets the EP monograph and is made in accordance with Good Manufacturing Practices (GMP). It can be used by customers in the relevant part of the quality module of their product dossiers allowing them to forgo the onerous task of supplying all the specific information about the product.
R.N. PHARMACEUTICALS has invested over US$10 million in its manufacturing facilities in recent years. They have recently opened a new state-of-the-art facility which increases their production capacity to 3,000 tonnes, over 50% of the world production demand, making them the world's largest producer. Univar continues to be R.N. PHARMACEUTICAL's distributor in Europe, USA and Canada, using its high quality supply chain to ensure that customers can be confident of the security of supply, overall quality assurance and cost effective execution.
'We look forward to continuing to develop the Chlorohexidine Gluconate market in Europe in partnership with R.N. PHARMACEUTICALS', commented 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'.
Rohit Garg, Managing Director of R.N. PHARMACEUTICALS added, "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."
To learn more about Univar Pharma Ingredients’ products and services, please visit Univar at Stand 30D62 in Hall 3 at CPhI Worldwide, 30 September to 2 October 2008, Frankfurt.
Univar Pharma Ingredients
Univar Pharma Ingredients is the global brand of Univar to the pharmaceutical raw material market. Operating across Europe and supplied by world leading producers, Univar Pharma Ingredients combines global cost effective supply of a broad range of raw materials with the specific quality and regulatory standards required by the pharmaceutical manufacturing market.
Univar is one of the world's leading independent distributors of industrial chemicals and providers of related specialty services, operating throughout North America and Europe. Univar endeavors to service its customer base, made up of some 250,000 industrial customers, with a full portfolio of products. Univar operates a network of over 200 distribution centers, located throughout the United States, Canada, Europe and China. In 2006, Univar had pro forma sales of USD 8.0 billion. Univar has approximately 7,900 employees based throughout North America, Europe and China. The company's registered office is in Rotterdam, the Netherlands, with administrative support offices in Bellevue, Washington, USA, and Bradford, England, UK. For more information, visit: http://www.univareurope.com/ and http://www.univarcorp.com/.