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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 : 2022-10-11

Pay. Date : 2022-09-23

DMF Number : 37322

Submission : 2022-07-19

Status : Active

Type : II

Biophore

Looking for Drug Master Files (DMF) for 37322 of Biophore India Pharmaceuticals Pvt Ltd

Looking for Drug Master Files (DMF) for 37322 of Biophore India Pharmaceuticals Pvt Ltd 1

20

Biophore India Pharmaceuticals Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and 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 MANGANESE SULFATE MONOHYDRATE, with a corresponding US DMF Number 37322.

Remarkably, this DMF maintains an Active status since its submission on July 19, 2022, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 11, 2022, and payment made on September 23, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II