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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 : 2025-02-05

Pay. Date : 2024-12-31

DMF Number : 34631

Submission : 2020-03-06

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 34631 of Maithri Drugs Private Ltd

Looking for Drug Master Files (DMF) for 34631 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 NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS), with a corresponding US DMF Number 34631.

Remarkably, this DMF maintains an Active status since its submission on March 06, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 05, 2025, and payment made on December 31, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II