Axplora- The partner of choice for complex APIs.
01 1Axplora
01 1FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED)
01 1Germany
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-02
Pay. Date : 2018-10-31
DMF Number : 20463
Submission : 2007-04-24
Status : Active
Type : II
20
Farmabios Spa, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Axplora- The partner of choice for complex APIs.
One of their notable products is FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED), with a corresponding US DMF Number 20463.
Remarkably, this DMF maintains an Active status since its submission on April 24, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 02, 2018, and payment made on October 31, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
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