01 1Zhuhai Rundu Pharmaceutical
01 1IRBESARTAN, NON-STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-05
Pay. Date : 2019-11-15
DMF Number : 32803
Submission : 2019-11-12
Status : Active
Type : II
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Zhuhai Rundu Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is IRBESARTAN, NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 32803.
Remarkably, this DMF maintains an Active status since its submission on November 12, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 05, 2020, and payment made on November 15, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
