As the oldest commercial supplier of biodegradable polymers in the U.S., we have 30 years of experience producing high quality biodegradable polymers for the drug delivery and medical device industries. We offer a full range of standard polymers from glycolide, lactide and ε-caprolactone monomers, and can also provide expert developmental input and custom synthesis.
DURECT has combined the expertise and capabilities of two companies, Birmingham Polymers Inc. and Absorbable Polymer Technologies, both of which have commercialized polymers in FDA approved medical devices and pharmaceutical products.
We hold patents relating to the use of biodegradable polymers for improved processes in drug delivery and the manufacture of biodegradable medical devices.
DURECT produces its line of LACTEL® Absorbable Polymers at its modern, well-equipped production and laboratory facilities in Birmingham, Alabama, USA. Polymers are produced in ISO 8 clean rooms with controlled temperature and humidity. Production is conducted according to the International Pharmaceutical Excipients Council (IPEC) Good Manufacturing Practices guidance for Bulk Pharmaceutical Excipients, which are recognized and published in the United States Pharmacopeia. Both Drug and Device Master Files (DMFs) are maintained with the FDA.