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01 1Aspen API

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PharmaCompass

01

GDUFA

DMF Review : Complete

Rev. Date : 2016-09-14

Pay. Date : 2016-09-02

DMF Number : 7366

Submission : 1988-03-04

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 7366 of Aspen Oss Bv

Looking for Drug Master Files (DMF) for 7366 of Aspen Oss Bv 1

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 ETHYNODIOL DIACETATE, with a corresponding US DMF Number 7366.

Remarkably, this DMF maintains an Active status since its submission on March 04, 1988, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 14, 2016, and payment made on September 02, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II