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List of Drug Master Files (DMF) for 28955 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 1Biophore India Pharmaceuticals Pvt Ltd

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

GDUFA

DMF Review : Complete

Rev. Date : 2015-07-02

Pay. Date : 2015-04-01

DMF Number : 28955

Submission : 2015-01-09

Status : Active

Type : II

Biophore

Looking for Drug Master Files (DMF) for 28955 of Biophore India Pharmaceuticals Pvt Ltd

Looking for Drug Master Files (DMF) for 28955 of Biophore India Pharmaceuticals Pvt Ltd 1

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Biophore India Pharmaceuticals Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from EDQM.

They are recognized for Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

One of their notable products is DIMETHYL FUMARATE, with a corresponding US DMF Number 28955.

Remarkably, this DMF maintains an Active status since its submission on January 09, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 02, 2015, and payment made on April 01, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II