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 1ICATIBANT ACETATE
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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 : 2016-12-21
Pay. Date : 2016-09-27
DMF Number : 30526
Submission : 2016-09-27
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 ICATIBANT ACETATE, with a corresponding US DMF Number 30526.
Remarkably, this DMF maintains an Active status since its submission on September 27, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 21, 2016, and payment made on September 27, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II