Leading the way in respect of quality standards for pharmaceutical excipients
BASF's Geismar site meets the strict requirements of the United States Pharmacopeia
(PresseBox) (Ludwigshafen, Germany, )BASF's site in Geismar, Louisiana/USA is one of the first in the world to meet the strict quality standards of the United States Pharmacopeia (USP) for the production of pharmaceutical excipients. Following a detailed audit, the polyvinylpyrrolidones (PVPs) made at this site were certified under the new "USP Excipient Verification Program". PVP is sold throughout the world by BASF under the trade name Kollidon® and is used in the pharmaceutical industry primarily as a binder for tablets. The active ingredient PVP-Iodine, a highly efficient and very compatible disinfectant which is also produced in Geismar, also satisfies the USP requirements and has been certified successfully.
Up until now, the production of pharmaceutical excipients has not been subject to the same strict guidelines as active ingredients. BASF is committing itself, voluntarily, to complying with the requirements of current Good Manufacturing Practice (cGMP for short) with regard to the manufacture of excipients.
"With this commitment to the USP's strict requirements, we are providing assurance to our customers in the pharmaceutical industry and thus, ultimately, to the patients who are taking medication," stresses Dr. Tim Bölke, who is responsible at BASF for the global marketing of excipients and active ingredients. "The USP certificate is written evidence of our high quality standards. Reliable manufacturing processes and high-quality products are our top priority."
The United States Pharmacopeia is an independent institution that sets general standards for pharmaceutical excipients and active pharmaceutical ingredients in the United States of America in the form of monographs. With its Verification Program, the USP is reacting to the population's growing concern about the quality of the constituents in pharmaceutical products. Certification involves not only examination of compliance with cGMP guidelines, but also of the documentation of production checks and quality checks. In addition, product samples are analyzed in the laboratory.
About the business unit Pharma Ingredients & Services
BASF produces and markets a broad range of active ingredients and excipients, as well as exclusive synthesis services for the pharmaceutical industry. These products are made using the latest technologies, to the highest quality standards and in compliance with cGMP guidelines.