01 1Hybio Pharmaceutical
01 1ABALOPARATIDE, NON-STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-08
Pay. Date : 2023-12-08
DMF Number : 39223
Submission : 2023-11-30
Status : Active
Type : II
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Hybio Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is ABALOPARATIDE, NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 39223.
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 08, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
