ISP Pharmaceuticals announced it will present the merits for manufacturing and supply of excipient products under verifiable GMP conditions at the 10th annual Indian Pharmacopoeial Commission – United States Pharmacopoeial Convention in Hyderabad, India, February 18, 2011. The annual conference offers stakeholders dedicated to quality medicines an opportunity for a science-based dialogue on key issues affecting the regions. Laxmikanth Sadafule, technical marketing manager for ISP Pharmaceuticals, India, will outline the steps involved in aligning excipients manufacturing and supply to GMP and discuss the correlation between verifiable good manufacturing practices, high quality products and maintaining secure traceable supply chain to customers.

A major supplier of excipients to the pharmaceutical manufacturing industries of the world, ISP crospovidone, copovidone and povidone products carry the “Verified Pharmaceutical Ingredients” mark by the United States Pharmacopoeia. The USP Verified Pharmaceutical Ingredients Programme is a rigorous voluntary verification program initiated by the USP in response to increasing concerns about the quality and consistency of pharmaceutical ingredients. The USP Verified mark is awarded to companies and pharmaceutical ingredients that pass all USP verification requirements, including a GMP audit, thorough documentation review and testing for purity and potency.

According to Philip Strenger, senior vice president global pharmaceuticals, with a pharmaceutical ingredient supply chain that extends throughout the world, securing and verifying high quality excipients had become complicated and onerous for the pharmaceutical industry. “ISP recognizes this increasing complexity within the supply chain and is committed to being a leader in establishing quality standards for excipients.  Several years ago, ISP adopted USP’s Verified Pharmaceutical Ingredients Programme and we continue to participate in the audit program conducted by International Pharmaceutical Excipients Auditing, Inc (IPEA).  Today, we are actively supporting industry efforts, such as the Excipact Certification Programme, to assure quality standards.  As one of the world’s largest suppliers of pharmaceutical excipients and a founding member of the International Pharmaceutical Excipients Council (IPEC), we are committed to ensuring our trademark excipient products set the benchmark in quality.”

Last year, ISP introduced a new generation of ultra pure crospovidone specifically for the pharmaceutical industry. Offered under the trade names Polyplasdone Ultra and Polyplasdone Ultra-10, the excipients are manufactured to standards well above commercial products currently in the market. The high purity grades have peroxide levels that are more than 10 times lower than standard forms of crospovidone putting them even further below the current specifications as required by the European Pharmacopoeia monograph for crospovidone.

International Specialty Products Inc. (ISP) is a leading global supplier of specialty chemicals and performance enhancing products for a wide variety of personal care, pharmaceutical, beverage and industrial applications.

ISP Pharmaceuticals is a global business providing technology for drug synthesis, drug solubilization, excipients and coatings. The business is committed to providing quality products and services and reliable customer support to advance the commercialization goals of the world’s largest producers of pharmaceuticals and dietary supplements.