Quality
We are committed to supplying the pharmaceutical industry with the highest-quality products, always manufactured to the highest industry standards. To this end, our quality groups continuously monitor, audit, train and upgrade our quality systems. Manufactured in state-of-the-art facilities, our products for pharmaceutical applications are made to suitable cGMP standards and conform to the current monographs in the United States, European and Japanese pharamacopeias.
As a founding member of the International Excipients Council (IPEC), we support and follow IPEC guidelines.
USP Verified Pharmaceutical Ingredients
The following products used in pharmaceutical manufacturing have been awarded the use of the “Verified Pharmaceutical Ingredients” mark by the United States Pharmacopeia (USP):
- Plasdone® C/K Povidones
- Plasdone® S-630 Copovidone,
- Polyplasdone® XL and XL-10 Crospovidones
The USP Verified Pharmaceutical Ingredients Program 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. The USP Verified Pharmaceutical Ingredient Mark is displayed on every container of verified ingredients, as well as on accompanying certificates of analysis, confirming the quality and integrity of the products. In addition, verified ingredients become part of the List of Ingredients Verified by USP, displayed on the USP web site.
ISP’s USP-verified pharmaceutical products have also been issued a USP Certificate of Standards Compliance – currently the highest-quality and most comprehensive verification on the market. Pharmaceutical manufacturers that purchase ISP products verified by USP are assured that they are consistent in quality from batch to batch; meet label or certificate of analysis claims for identification, strength, purity, and quality; are manufactured in accordance with the internationally accepted Good Manufacturing Practices for Excipients; and meet requirements for acceptable limits of contamination.
Our USP-verified products are manufactured at our excipient production plants in Calvert City, Kentucky or Texas City, Texas.
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