KEY PRODUCTS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
01 1FOSPHENYTOIN SODIUM USP
01 1U.S.A
01 1Active
01 1Complete
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-03
Pay. Date : 2023-03-30
DMF Number : 37565
Submission : 2023-03-20
Status : Active
Type : II
20
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 FOSPHENYTOIN SODIUM USP, with a corresponding US DMF Number 37565.
Remarkably, this DMF maintains an Active status since its submission on March 20, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 03, 2023, and payment made on March 30, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
