KEY PRODUCTS
Axplora is your partner of choice for complex APIs.
01 1Axplora
01 1BALSALAZIDE DISODIUM
01 1Germany
01 1Active
01 1Complete
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-10
Pay. Date : 2021-08-06
DMF Number : 16425
Submission : 2003-02-17
Status : Active
Type : II
20
Pharmazell Gmbh, 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 BALSALAZIDE DISODIUM, with a corresponding US DMF Number 16425.
Remarkably, this DMF maintains an Active status since its submission on February 17, 2003, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 10, 2021, and payment made on August 06, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
