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List of Drug Master Files (DMF) for 26350 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Concord Biotech (1)

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01 EVEROLIMUS USP (WITH 2% BHT) (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
26350
Active
2013-06-14
Complete
2013-10-01
2013-06-13
II
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Looking for Drug Master Files (DMF) for 26350 of Concord Biotech Ltd

Looking for Drug Master Files (DMF) for 26350 of Concord Biotech Ltd 1

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Concord Biotech Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is EVEROLIMUS USP (WITH 2% BHT), with a corresponding US DMF Number 26350.

Remarkably, this DMF maintains an Active status since its submission on June 14, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 01, 2013, and payment made on June 13, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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