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01 1Henan Dongtai Pharma

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GDUFA

DMF Review : Complete

Rev. Date : 2022-09-08

Pay. Date : 2022-07-05

DMF Number : 37092

Submission : 2022-05-19

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 37092 of Henan Dongtai Pharm Co Ltd

Looking for Drug Master Files (DMF) for 37092 of Henan Dongtai Pharm Co Ltd 1

20

Henan Dongtai Pharm Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is CELECOXIB, with a corresponding US DMF Number 37092.

Remarkably, this DMF maintains an Active status since its submission on May 19, 2022, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 08, 2022, and payment made on July 05, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II