Axplora is your partner of choice for complex APIs.
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01 1Axplora
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01 1FLUNISOLIDE ANHYDROUS USP
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01 1Germany
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-15
DMF Number : 19477
Submission : 2006-05-31
Status : Active
Type : II
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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 is your partner of choice for complex APIs.
One of their notable products is FLUNISOLIDE ANHYDROUS USP, with a corresponding US DMF Number 19477.
Remarkably, this DMF maintains an Active status since its submission on May 31, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 07, 2013, and payment made on February 15, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II