01 1Zhejiang Neo-Dankong Pharm. Co.,Ltd.
01 1ROSUVASTATIN CALCIUM, NON- STERILE BULK DRUG SUBSTANCES
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-21
Pay. Date : 2013-12-17
DMF Number : 25781
Submission : 2012-02-10
Status : Active
Type : II
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Zhejiang Lepu Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is ROSUVASTATIN CALCIUM, NON- STERILE BULK DRUG SUBSTANCES, with a corresponding US DMF Number 25781.
Remarkably, this DMF maintains an Active status since its submission on February 10, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 21, 2014, and payment made on December 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
