01 1Hetero Drugs
01 1PREGABALIN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-21
Pay. Date : 2013-11-27
DMF Number : 27354
Submission : 2013-07-29
Status : Active
Type : II
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Hetero Drugs 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 PREGABALIN, with a corresponding US DMF Number 27354.
Remarkably, this DMF maintains an Active status since its submission on July 29, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 21, 2014, and payment made on November 27, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
