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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 : 2018-03-20

Pay. Date : 2018-03-01

DMF Number : 32201

Submission : 2017-10-28

Status : Active

Type : II

Cohance

Looking for Drug Master Files (DMF) for 32201 of Cohance Lifesciences Ltd

Looking for Drug Master Files (DMF) for 32201 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 PIRFENIDONE, with a corresponding US DMF Number 32201.

Remarkably, this DMF maintains an Active status since its submission on October 28, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 20, 2018, and payment made on March 01, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II