KEY PRODUCTS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
01 1RAMELTEON
01 1India
01 1Active
01 1Complete
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-12
Pay. Date : 2020-09-24
DMF Number : 34414
Submission : 2019-12-31
Status : Active
Type : II
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 RAMELTEON, with a corresponding US DMF Number 34414.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 12, 2020, and payment made on September 24, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
