List of Drug Master Files (DMF) for 10457 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Question

Looking for Drug Master Files (DMF) for 10457 of Aspen Oss Bv

score 20 · Accepted Answer

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 MIRTAZAPINE, with a corresponding US DMF Number 10457.

Remarkably, this DMF maintains an Active status since its submission on August 30, 1993, highlighting commitment to regulatory compliance.