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01 1Zhejiang Ausun Pharmaceutical

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PharmaCompass

Looking for Drug Master Files (DMF) for 38901 of Zhejiang Ausun Pharmaceutical Co Ltd

Looking for Drug Master Files (DMF) for 38901 of Zhejiang Ausun Pharmaceutical Co Ltd 1

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

They are recognized for Accelerating Development of APIs & Chemical Intermediates through innovation.

One of their notable products is PILOCARPINE HYDROCHLORIDE, with a corresponding US DMF Number 38901.

Remarkably, this DMF maintains an Active status since its submission on September 30, 2023, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 29, 2023, and payment made on November 24, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II