01 1Hetero Drugs
01 1GLYCEROL PHENYLBUTYRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-13
Pay. Date : 2020-02-26
DMF Number : 34468
Submission : 2020-04-21
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 GLYCEROL PHENYLBUTYRATE, with a corresponding US DMF Number 34468.
Remarkably, this DMF maintains an Active status since its submission on April 21, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 13, 2020, and payment made on February 26, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
