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Athena Athena

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List of Drug Master Files (DMF) for 26337 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 ETHACRYNIC ACID USP NON-STERILE BULK DRUG (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 26337 of Chemwerth Inc

Looking for Drug Master Files (DMF) for 26337 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 ETHACRYNIC ACID USP NON-STERILE BULK DRUG, with a corresponding US DMF Number 26337.

Remarkably, this DMF maintains an Active status since its submission on January 31, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 27, 2013, and payment made on February 06, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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