KEY PRODUCTS
Axplora is your partner of choice for complex APIs.
01 1Axplora
01 15-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE)
01 1Germany
01 1Active
01 1Complete
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 8070
Submission : 1989-05-09
Status : Active
Type : II
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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 5-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE), with a corresponding US DMF Number 8070.
Remarkably, this DMF maintains an Active status since its submission on May 09, 1989, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 16, 2014, and payment made on November 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
