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 1TOLVAPTAN AMORPHOUS
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 : 2025-04-21
Pay. Date : 2025-03-21
DMF Number : 40628
Submission : 2024-10-10
Status : Active
Type : II
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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 TOLVAPTAN AMORPHOUS, with a corresponding US DMF Number 40628.
Remarkably, this DMF maintains an Active status since its submission on October 10, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 21, 2025, and payment made on March 21, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
