01 1Unichem Laboratories Limited
01 1BACLOFEN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-22
Pay. Date : 2018-01-12
DMF Number : 32431
Submission : 2018-03-07
Status : Active
Type : II
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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 BACLOFEN USP, with a corresponding US DMF Number 32431.
Remarkably, this DMF maintains an Active status since its submission on March 07, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 22, 2018, and payment made on January 12, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
