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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 : 2024-12-17

Pay. Date : 2024-11-22

DMF Number : 38637

Submission : 2023-08-25

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 38637 of Maithri Laboratories Private Ltd

Looking for Drug Master Files (DMF) for 38637 of Maithri Laboratories Private Ltd 1

20

Maithri Laboratories 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 VILOXAZINE HYDROCHLORIDE, with a corresponding US DMF Number 38637.

Remarkably, this DMF maintains an Active status since its submission on August 25, 2023, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 17, 2024, and payment made on November 22, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II