01 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
01 1FLUDARABINE PHOSPHATE DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-17
Pay. Date : 2022-10-29
DMF Number : 34509
Submission : 2020-04-29
Status : Active
Type : II
20
Hubei Biocause Heilen Pharmaceutical 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 FLUDARABINE PHOSPHATE DRUG SUBSTANCE, with a corresponding US DMF Number 34509.
Remarkably, this DMF maintains an Active status since its submission on April 29, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 17, 2023, and payment made on October 29, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
