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List of Drug Master Files (DMF) for 27399 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 ROMIDEPSIN (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
27399
Active
2013-11-01
Complete
2014-03-15
2013-10-25
II
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Looking for Drug Master Files (DMF) for 27399 of Concord Biotech Ltd

Looking for Drug Master Files (DMF) for 27399 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 ROMIDEPSIN, with a corresponding US DMF Number 27399.

Remarkably, this DMF maintains an Active status since its submission on November 01, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 15, 2014, and payment made on October 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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