01 1Hybio Pharmaceutical
01 1TERIPARATIDE, NON STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-21
Pay. Date : 2021-12-22
DMF Number : 36502
Submission : 2021-12-29
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 TERIPARATIDE, NON STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 36502.
Remarkably, this DMF maintains an Active status since its submission on December 29, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 21, 2022, and payment made on December 22, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
