KEY PRODUCTS
Aspen API. More than just an API™
01 1Aspen API
01 1LEUPRORELIN HIGHLY PURIFIED
01 1Netherlands
01 1Active
01 1Complete
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-29
Pay. Date : 2020-11-09
DMF Number : 28808
Submission : 2014-11-06
Status : Active
Type : II
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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 LEUPRORELIN HIGHLY PURIFIED, with a corresponding US DMF Number 28808.
Remarkably, this DMF maintains an Active status since its submission on November 06, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 29, 2021, and payment made on November 09, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
