KEY PRODUCTS
Axplora is your partner of choice for complex APIs.
01 1Axplora
01 1STERILE PREDNISOLONE-21-ACETATE MICRONIZED
01 1Germany
01 1Active
01 1Complete
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-29
Pay. Date : 2020-09-22
DMF Number : 32896
Submission : 2018-07-16
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 is your partner of choice for complex APIs.
One of their notable products is STERILE PREDNISOLONE-21-ACETATE MICRONIZED, with a corresponding US DMF Number 32896.
Remarkably, this DMF maintains an Active status since its submission on July 16, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 29, 2020, and payment made on September 22, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
