Axplora is your partner of choice for complex APIs.
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01 1Axplora
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01 1METHYLPREDNISOLONE ACETATE STERILE
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01 1Germany
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2013-12-31
DMF Number : 27325
Submission : 2013-07-19
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 METHYLPREDNISOLONE ACETATE STERILE, with a corresponding US DMF Number 27325.
Remarkably, this DMF maintains an Active status since its submission on July 19, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 23, 2014, and payment made on December 31, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II