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Athena Athena

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List of Drug Master Files (DMF) for 29213 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 BCN Peptides (1)

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01 ICATIBANT ACETATE (1)

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01 Spain (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
29213
Active
2015-03-26
Complete
2015-09-21
2015-04-28
II
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Looking for Drug Master Files (DMF) for 29213 of Bcn Peptides Sa

Looking for Drug Master Files (DMF) for 29213 of Bcn Peptides Sa 1

20

Bcn Peptides Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ICATIBANT ACETATE, with a corresponding US DMF Number 29213.

Remarkably, this DMF maintains an Active status since its submission on March 26, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 21, 2015, and payment made on April 28, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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