01 1Xinyu Pharmaceutical
01 1CLINDAMYCIN HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-09
Pay. Date : 2018-01-31
DMF Number : 32342
Submission : 2018-01-08
Status : Active
Type : II
20
Xinyu Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is CLINDAMYCIN HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE), with a corresponding US DMF Number 32342.
Remarkably, this DMF maintains an Active status since its submission on January 08, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 09, 2018, and payment made on January 31, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
