Published 7 Jan 2013
According to the GDUFA regulation in place for companies with registrations in the US, our API production sites in Oss/The Netherlands (De Geer/Veersemeer and Moleneind/Kloosterstraat) have been self-identified according to FDA requirements.
The following APIs have been registered after the self-identification of our production sites:
* Ethinyl estradiol
* Estradiol micronized
* Naltrexone
* Norethindrone
* Norethindrone acetate
* Rocuronium bromide
The costs for GDUFA registration are being covered 100% by Aspen Oss, and will not be at the expense of customers filing these APIs at the FDA!
