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01 1Metrochem API Private Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

GDUFA

DMF Review : Complete

Rev. Date : 2023-11-07

Pay. Date : 2023-09-22

DMF Number : 36085

Submission : 2021-07-05

Status : Active

Type : II

Metrochem

Looking for Drug Master Files (DMF) for 36085 of Metrochem Api Private Ltd

Looking for Drug Master Files (DMF) for 36085 of Metrochem Api Private Ltd 1

20

Metrochem Api Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

One of their notable products is BEMPEDOIC ACID, with a corresponding US DMF Number 36085.

Remarkably, this DMF maintains an Active status since its submission on July 05, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 07, 2023, and payment made on September 22, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II