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01 1Mankind Pharma

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

GDUFA

DMF Review : Complete

Rev. Date : 2022-06-21

Pay. Date : 2022-06-01

DMF Number : 37011

Submission : 2022-04-27

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 37011 of Mankind Pharma Ltd

Looking for Drug Master Files (DMF) for 37011 of Mankind Pharma Ltd 1

20

Mankind Pharma Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

One of their notable products is BACLOFEN USP, with a corresponding US DMF Number 37011.

Remarkably, this DMF maintains an Active status since its submission on April 27, 2022, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 21, 2022, and payment made on June 01, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II