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01 1Amphastar Pharmaceuticals

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PharmaCompass

Looking for Drug Master Files (DMF) for 29876 of Amphastar Nanjing Pharmaceuticals Inc

Looking for Drug Master Files (DMF) for 29876 of Amphastar Nanjing Pharmaceuticals Inc 1

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Amphastar Nanjing Pharmaceuticals Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ISOPROTERENOL HYDROCHLORIDE USP, with a corresponding US DMF Number 29876.

Remarkably, this DMF maintains an Active status since its submission on November 09, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 13, 2016, and payment made on November 16, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II