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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 ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE, with a corresponding US DMF Number 20709.
Remarkably, this DMF maintains an Active status since its submission on July 20, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 27, 2019, and payment made on December 20, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II