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01 1Hubei Gedian Humanwell Pharmaceutical

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PharmaCompass

Looking for Drug Master Files (DMF) for 25056 of Hubei Gedian Humanwell Pharmaceutical Co Ltd

Looking for Drug Master Files (DMF) for 25056 of Hubei Gedian Humanwell Pharmaceutical Co Ltd 1

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Hubei Gedian Humanwell Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

One of their notable products is FINASTERIDE, with a corresponding US DMF Number 25056.

Remarkably, this DMF maintains an Active status since its submission on June 17, 2011, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 27, 2022, and payment made on August 04, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II