01 1J.B.Chemicals & Pharmaceuticals
01 1NIFEDIPINE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-24
Pay. Date : 2015-01-07
DMF Number : 16730
Submission : 2003-07-29
Status : Active
Type : II
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Unique Chemicals (a Div Of J B Chemicals And Pharmaceuticals 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 16730.
Remarkably, this DMF maintains an Active status since its submission on July 29, 2003, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2015, and payment made on January 07, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
