Please Wait
Applying Filters...
Menu
Xls
Filters Filter
Cross PopUp
FILTER :

filter clear-filterReset all filters

01 1Biophore India Pharmaceuticals Pvt Ltd

filter clear-filterReset all filters

filter clear-filterReset all filters

filter clear-filterReset all filters

filter clear-filterReset all filters

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 : 2018-07-09

Pay. Date : 2018-05-30

DMF Number : 32860

Submission : 2018-05-30

Status : Active

Type : II

Biophore

Looking for Drug Master Files (DMF) for 32860 of Biophore India Pharmaceuticals Pvt Ltd

Looking for Drug Master Files (DMF) for 32860 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 ELIGLUSTAT TARTRATE PREMIX, with a corresponding US DMF Number 32860.

Remarkably, this DMF maintains an Active status since its submission on May 30, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 09, 2018, and payment made on May 30, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II