Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
KEY PRODUCTS
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01 1Biophore India Pharmaceuticals Pvt Ltd
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01 1TIOPRONIN
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01 1India
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01 1Active
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01 1Complete
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-07
Pay. Date : 2021-08-18
DMF Number : 35512
Submission : 2020-12-31
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 TIOPRONIN, with a corresponding US DMF Number 35512.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 07, 2021, and payment made on August 18, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II