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List of Drug Master Files (DMF) for 21907 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 SODIUM 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
21907
Active
2008-08-21
Complete
2013-04-30
2013-04-22
II
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Looking for Drug Master Files (DMF) for 21907 of Concord Biotech Ltd

Looking for Drug Master Files (DMF) for 21907 of Concord Biotech Ltd 1

20

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 SODIUM USP, with a corresponding US DMF Number 21907.

Remarkably, this DMF maintains an Active status since its submission on August 21, 2008, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 30, 2013, and payment made on April 22, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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