01 1Bioindustria L.I.M. Spa
01 1PRAZOSIN HYDROCHLORIDE BULK SUBSTANCE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-27
Pay. Date : 2017-12-11
DMF Number : 15321
Submission : 2001-02-28
Status : Active
Type : II
20
Bioindustria Laboratorio Italiano Medicinali 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 PRAZOSIN HYDROCHLORIDE BULK SUBSTANCE, with a corresponding US DMF Number 15321.
Remarkably, this DMF maintains an Active status since its submission on February 28, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 27, 2018, and payment made on December 11, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
