KEY PRODUCTS
Aspen API. More than just an API™
01 1Aspen API
01 1GANIRELIX
01 1Netherlands
01 1Active
01 1Complete
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-07
Pay. Date : 2024-03-05
DMF Number : 13971
Submission : 1999-02-04
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 GANIRELIX, with a corresponding US DMF Number 13971.
Remarkably, this DMF maintains an Active status since its submission on February 04, 1999, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 07, 2024, and payment made on March 05, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
