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 1ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
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 : 2021-09-29
Pay. Date : 2021-08-18
DMF Number : 35991
Submission : 2021-06-28
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 ERTUGLIFLOZIN L-PYROGLUTAMIC ACID, with a corresponding US DMF Number 35991.
Remarkably, this DMF maintains an Active status since its submission on June 28, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 29, 2021, and payment made on August 18, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
