01 1Glochem Industries
01 1AMLODIPINE BESYLATE (PROCESS 1)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-05
Pay. Date : 2014-01-06
DMF Number : 27810
Submission : 2013-12-16
Status : Active
Type : II
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Glochem Industries Private 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 AMLODIPINE BESYLATE (PROCESS 1), with a corresponding US DMF Number 27810.
Remarkably, this DMF maintains an Active status since its submission on December 16, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 05, 2014, and payment made on January 06, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
