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List of Drug Master Files (DMF) for 25644 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 ChemWerth Inc (1)

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01 MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE (1)

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01 U.S.A (1)

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01 Active (1)

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01 Complete (1)

Looking for Drug Master Files (DMF) for 25644 of Chemwerth Inc

Looking for Drug Master Files (DMF) for 25644 of Chemwerth Inc 1

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Chemwerth Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

One of their notable products is MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE, with a corresponding US DMF Number 25644.

Remarkably, this DMF maintains an Active status since its submission on December 29, 2011, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 21, 2013, and payment made on November 21, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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