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Athena Athena

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List of Drug Master Files (DMF) for 32119 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Quimica Sintetica S.A. (1)

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01 APREMILAST (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
32119
Active
2017-10-10
Complete
2018-02-02
2017-11-06
II
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Looking for Drug Master Files (DMF) for 32119 of Quimica Sintetica Sa

Looking for Drug Master Files (DMF) for 32119 of Quimica Sintetica Sa 1

20

Quimica Sintetica Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from EDQM.

One of their notable products is APREMILAST, with a corresponding US DMF Number 32119.

Remarkably, this DMF maintains an Active status since its submission on October 10, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 02, 2018, and payment made on November 06, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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