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List of Drug Master Files (DMF) for 26446 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

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01 ZILEUTON (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

Looking for Drug Master Files (DMF) for 26446 of Biophore India Pharmaceuticals Pvt Ltd

Looking for Drug Master Files (DMF) for 26446 of Biophore India Pharmaceuticals Pvt Ltd 1

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Biophore India Pharmaceuticals Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from 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 ZILEUTON, with a corresponding US DMF Number 26446.

Remarkably, this DMF maintains an Active status since its submission on September 26, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 16, 2014, and payment made on June 05, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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