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List of Drug Master Files (DMF) for 12803 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 PAMIDRONIC ACID (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 12803 of Chemwerth Inc

Looking for Drug Master Files (DMF) for 12803 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 PAMIDRONIC ACID, with a corresponding US DMF Number 12803.

Remarkably, this DMF maintains an Active status since its submission on December 22, 1997, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 24, 2012, and payment made on November 19, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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