01 1Changzhou Pharmaceutical Factory
01 1OBETICHOLIC ACID
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-15
Pay. Date : 2023-01-17
DMF Number : 37355
Submission : 2022-08-15
Status : Active
Type : II
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Changzhou Pharmaceutical Factory, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is OBETICHOLIC ACID, with a corresponding US DMF Number 37355.
Remarkably, this DMF maintains an Active status since its submission on August 15, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 15, 2023, and payment made on January 17, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
