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01 1Cohance Lifesciences

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : Complete

Rev. Date : 2019-09-12

Pay. Date : 2019-06-11

DMF Number : 31298

Submission : 2017-01-04

Status : Active

Type : II

Cohance

Looking for Drug Master Files (DMF) for 31298 of Cohance Lifesciences Ltd

Looking for Drug Master Files (DMF) for 31298 of Cohance Lifesciences Ltd 1

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 ZONISAMIDE USP, with a corresponding US DMF Number 31298.

Remarkably, this DMF maintains an Active status since its submission on January 04, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 12, 2019, and payment made on June 11, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II