List of Drug Master Files (DMF) for 12424 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Question

Looking for Drug Master Files (DMF) for 12424 of Bioindustria Farmaceutici Spa

score 20 · Accepted Answer

Bioindustria Farmaceutici Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Production of small & large volume I.V. Solutions// Generic Drug Products// APIs// GMP certified.

One of their notable products is TERAZOSIN HCI. 2H20 BULK SUBSTANCE, with a corresponding US DMF Number 12424.

Remarkably, this DMF maintains an Inactive status since its submission on March 17, 1997, highlighting commitment to regulatory compliance.