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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 : 2019-11-29

Pay. Date : 2019-10-03

DMF Number : 34170

Submission : 2019-10-03

Status : Active

Type : II

Biophore

Looking for Drug Master Files (DMF) for 34170 of Biophore India Pharmaceuticals Pvt Ltd

Looking for Drug Master Files (DMF) for 34170 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 SUGAMMADEX SODIUM, with a corresponding US DMF Number 34170.

Remarkably, this DMF maintains an Active status since its submission on October 03, 2019, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 29, 2019, and payment made on October 03, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II