01 1Bioindustria L.I.M. Spa
01 1TERAZOSIN HCL. 2H2O
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-12-08
Pay. Date : 2022-10-21
DMF Number : 14916
Submission : 2000-06-12
Status : Active
Type : II
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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 TERAZOSIN HCL. 2H2O, with a corresponding US DMF Number 14916.
Remarkably, this DMF maintains an Active status since its submission on June 12, 2000, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 08, 2022, and payment made on October 21, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
