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01 1Wuxi Fortune Pharmaceutical

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PharmaCompass

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BePharma
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GDUFA

DMF Review : Complete

Rev. Date : 2021-03-23

Pay. Date : 2020-09-25

DMF Number : 34866

Submission : 2020-09-14

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 34866 of Wuxi Fortune Pharmaceutical Co Ltd

Looking for Drug Master Files (DMF) for 34866 of Wuxi Fortune Pharmaceutical Co Ltd 1

20

Wuxi Fortune Pharmaceutical 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 MITOMYCIN, with a corresponding US DMF Number 34866.

Remarkably, this DMF maintains an Active status since its submission on September 14, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 23, 2021, and payment made on September 25, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II