KEY PRODUCTS
Aspen API. More than just an API™
01 1Aspen API
01 1NALTREXONE HYDROCHLORIDE
01 1Netherlands
01 1Active
01 1Complete
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-16
Pay. Date : 2012-12-20
DMF Number : 15102
Submission : 2000-10-18
Status : Active
Type : II
20
Aspen Oss Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Aspen API. More than just an API™
One of their notable products is NALTREXONE HYDROCHLORIDE, with a corresponding US DMF Number 15102.
Remarkably, this DMF maintains an Active status since its submission on October 18, 2000, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 16, 2015, and payment made on December 20, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
