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List of Drug Master Files (DMF) for 18908 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 TACROLIMUS 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
18908
Active
2005-10-24
Complete
2013-08-28
2013-08-16
II
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Looking for Drug Master Files (DMF) for 18908 of Concord Biotech Ltd

Looking for Drug Master Files (DMF) for 18908 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 TACROLIMUS USP, with a corresponding US DMF Number 18908.

Remarkably, this DMF maintains an Active status since its submission on October 24, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 28, 2013, and payment made on August 16, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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