BASF signs up to USP excipient scheme

By Gareth Macdonald

- Last updated on GMT

Related tags International pharmaceutical excipients Pharmaceutical excipients council Pharmacology

BASF's drug excipient manufacturing site in Geismar, Louisiana in
the USA has been accredited under the US Pharmacopoeia's (USP)
voluntary certification scheme.

The German chemicals giant is the third firm behind India's Deepak Fertilizers and Petrochemicals Corp and US-based International Specialty Products to have signed up to and met with the requirements of the USP's programme of self-regulation. The USP accreditation means that BASF's Louisiana facility is compliant with both the US Food and Drug Administration's Good Manufacturing Practice (GMP) criteria and guidelines issued by industry bodies like the International Pharmaceutical Excipients Council (IPEC) and the UK's Pharmaceutical Quality Group (PQG). "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,"​ stressed Dr Tim Bolke, who is responsible for the global marketing of excipients and active pharmaceutical ingredients (API) at BASF. He added that: "The USP certificate is written evidence of our high quality standards. Reliable manufacturing processes and high-quality products are our top priority​." BASF's site is used for the manufacture of the tablet binding agent polyvinylpyrrolidone (PVP), sold commercially as the Kollidon range. In the pharmaceutical industry PVP excipients are used to improve dry binding capacity through their plasticity, small particle size, high porosity and compact spherical shape. BASF originally developed the product to allow increased mechanical stability of tablets by increasing the tensile strength of their cores. In addition, the Geismar plant produces the disinfectant PVP-iodine, which is also widely used in the drug manufacturing industry. A 2007 report by BCC Research estimated that the global market would be worth more than $4.3bn (€2.8bn) by 2011, up from $3.5bn in 2006.Lack of regulations on excipients ​ At present, there are few formal rules covering the drug industry's use of excipients because the vast majority, around 90 per cent according to data released by the American International Pharmaceutical Excipients Council (IPEC), are produced for non-pharmaceutical applications. Indeed, aside from the certificate of analysis (CoA) that manufacturers are required to obtain, excipients used in drugs are only regulated at the final product stage by drugmakers themselves under generally applied safety criteria. In recent years, the lack of regulation in the excipient industry has been linked to several tragedies. In Haiti, Panama and Bangladesh for example, replacement of the excipient glycerol with diethylene glycol (DEG) by counterfeiters resulted in several hundred deaths.

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