01 1Zhejiang Lepu Pharmaceutical
01 1IDELALISIB NON-STERILE BULK DRUG SUBSTANCES
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-16
Pay. Date : 2018-03-23
DMF Number : 32519
Submission : 2018-03-20
Status : Active
Type : II
20
Zhejiang Lepu Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is IDELALISIB NON-STERILE BULK DRUG SUBSTANCES, with a corresponding US DMF Number 32519.
Remarkably, this DMF maintains an Active status since its submission on March 20, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 16, 2018, and payment made on March 23, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
