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List of Drug Master Files (DMF) for 22859 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 TOPOTECAN HCL (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 22859 of Chemwerth Inc

Looking for Drug Master Files (DMF) for 22859 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 TOPOTECAN HCL, with a corresponding US DMF Number 22859.

Remarkably, this DMF maintains an Active status since its submission on June 30, 2010, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 07, 2013, and payment made on September 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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