KEY PRODUCTS
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
01 1ChemExpress
01 1TRABECTEDIN (HM-326A_42)
01 1China
01 1Active
01 1Complete
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-03
Pay. Date : 2023-01-19
DMF Number : 36724
Submission : 2022-11-16
Status : Active
Type : II
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Shanghai Haoyuan Chemexpress Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
One of their notable products is TRABECTEDIN (HM-326A_42), with a corresponding US DMF Number 36724.
Remarkably, this DMF maintains an Active status since its submission on November 16, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 03, 2023, and payment made on January 19, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
