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01 1Medichem S.A

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PharmaCompass

Looking for Drug Master Files (DMF) for 36192 of Medichem Sa

Looking for Drug Master Files (DMF) for 36192 of Medichem Sa 1

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Medichem Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

One of their notable products is PAZOPANIB HYDROCHLORIDE, with a corresponding US DMF Number 36192.

Remarkably, this DMF maintains an Active status since its submission on October 04, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 29, 2021, and payment made on October 04, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II