List of Drug Master Files (DMF) for 16901 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Question

Looking for Drug Master Files (DMF) for 16901 of Ercros Industrial Sa Fyse

score 20 · Accepted Answer

Ercros Industrial Sa Fyse, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is LOVASTATIN (TECHNICAL GRADE), with a corresponding US DMF Number 16901.

Remarkably, this DMF maintains an Inactive status since its submission on October 13, 2003, highlighting commitment to regulatory compliance.