01 1Unichem Laboratories Limited
01 1NIFEDIPINE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-01
Pay. Date : 2018-12-20
DMF Number : 33562
Submission : 2019-02-07
Status : Active
Type : II
20
Unichem Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is NIFEDIPINE USP, with a corresponding US DMF Number 33562.
Remarkably, this DMF maintains an Active status since its submission on February 07, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 01, 2019, and payment made on December 20, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
