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01 1Hainan Poly Pharm

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Looking for Drug Master Files (DMF) for 38437 of Anhui Poly Pharm Co Ltd

Looking for Drug Master Files (DMF) for 38437 of Anhui Poly Pharm Co Ltd 1

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Anhui Poly 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 APREMILAST, with a corresponding US DMF Number 38437.

Remarkably, this DMF maintains an Active status since its submission on August 15, 2023, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 30, 2023, and payment made on September 25, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II