01 1Teva Pharmaceutical Industries
01 1GLYCEROL PHENYLBUTYRATE
01 1Israel
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-08
Pay. Date : 2022-05-24
DMF Number : 37042
Submission : 2022-06-27
Status : Active
Type : II
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Tapi Nl Bv, based in Israel, 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 37042.
Remarkably, this DMF maintains an Active status since its submission on June 27, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 08, 2022, and payment made on May 24, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
