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List of Drug Master Files (DMF) for 19231 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 MYCOPHENOLATE MOFETIL USP (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
19231
Active
2006-03-07
Complete
2014-02-18
2014-02-07
II
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Looking for Drug Master Files (DMF) for 19231 of Concord Biotech Ltd

Looking for Drug Master Files (DMF) for 19231 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 MYCOPHENOLATE MOFETIL USP, with a corresponding US DMF Number 19231.

Remarkably, this DMF maintains an Active status since its submission on March 07, 2006, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 18, 2014, and payment made on February 07, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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