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01 1Maithri Drugs

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMaithri Drugs: Dedicated to your API needs.

GDUFA

DMF Review : Complete

Rev. Date : 2024-12-13

Pay. Date : 2024-11-22

DMF Number : 31322

Submission : 2017-01-19

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 31322 of Maithri Drugs Private Ltd

Looking for Drug Master Files (DMF) for 31322 of Maithri Drugs Private Ltd 1

20

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

They are recognized for Maithri Drugs: Dedicated to your API needs.

One of their notable products is MIRTAZAPINE USP [ROUTE CODE - MZ), with a corresponding US DMF Number 31322.

Remarkably, this DMF maintains an Active status since its submission on January 19, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 13, 2024, and payment made on November 22, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II