01 1Hybio Pharmaceutical
01 1LINACLOTIDE NON-STERILE DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-01
Pay. Date : 2023-09-25
DMF Number : 37370
Submission : 2022-08-17
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 LINACLOTIDE NON-STERILE DRUG SUBSTANCE, with a corresponding US DMF Number 37370.
Remarkably, this DMF maintains an Active status since its submission on August 17, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 01, 2023, and payment made on September 25, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
