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01 1HEC Pharm

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PharmaCompass

Looking for Drug Master Files (DMF) for 33805 of Hec Pharm Co Ltd

Looking for Drug Master Files (DMF) for 33805 of Hec Pharm Co Ltd 1

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Hec 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 TENOFOVIR ALAFENAMIDE FUMARATE NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 33805.

Remarkably, this DMF maintains an Active status since its submission on April 30, 2019, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 24, 2019, and payment made on April 30, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II