01 1Taenaka Kogyo
01 1L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE
01 1Japan
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-03-14
DMF Number : 8866
Submission : 1990-11-30
Status : Active
Type : II
20
Taenaka Kogyo Co Ltd, based in Japan, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE, with a corresponding US DMF Number 8866.
Remarkably, this DMF maintains an Active status since its submission on November 30, 1990, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 27, 2017, and payment made on March 14, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
