List of Drug Master Files (DMF) for 15440 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Question

Looking for Drug Master Files (DMF) for 15440 of Evonik Operations Gmbh

score 20 · Accepted Answer

Evonik Operations Gmbh, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

One of their notable products is AZELASTINE HYDROCHLORIDE, with a corresponding US DMF Number 15440.

Remarkably, this DMF maintains an Active status since its submission on May 15, 2001, highlighting commitment to regulatory compliance.