01 1Zhejiang Peptites Biotech Co.,Ltd
01 1LINACLOTIDE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-12-17
Pay. Date : 2025-11-19
DMF Number : 42049
Submission : 2025-06-08
Status : Active
Type : II
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Zhejiang Peptites Biotech Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is LINACLOTIDE, with a corresponding US DMF Number 42049.
Remarkably, this DMF maintains an Active status since its submission on June 08, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 17, 2025, and payment made on November 19, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
