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List of Drug Master Files (DMF) for 29553 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 (BY AZEOTROPIC DISTILLATION) (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
29553
Active
2015-09-04
Complete
2016-03-02
2015-09-02
II
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Looking for Drug Master Files (DMF) for 29553 of Concord Biotech Ltd

Looking for Drug Master Files (DMF) for 29553 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 (BY AZEOTROPIC DISTILLATION), with a corresponding US DMF Number 29553.

Remarkably, this DMF maintains an Active status since its submission on September 04, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 02, 2016, and payment made on September 02, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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