01 1Hainan Poly Pharm
01 1GADOBUTROL USP
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-08
Pay. Date : 2023-12-13
DMF Number : 39149
Submission : 2023-11-30
Status : Active
Type : II
20
Anhui Poly Pharm Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is GADOBUTROL USP, with a corresponding US DMF Number 39149.
Remarkably, this DMF maintains an Active status since its submission on November 30, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 08, 2024, and payment made on December 13, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
