KEY PRODUCTS
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
01 1Cohance Lifesciences
01 1MEXILETINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-12
Pay. Date : 2021-03-24
DMF Number : 34958
Submission : 2020-06-19
Status : Active
Type : II
20
Cohance Lifesciences Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
One of their notable products is MEXILETINE HYDROCHLORIDE USP, with a corresponding US DMF Number 34958.
Remarkably, this DMF maintains an Active status since its submission on June 19, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 12, 2021, and payment made on March 24, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
