KEY PRODUCTS
Axplora is your partner of choice for complex APIs.
01 1Axplora
01 1N-ACETYL-L-CYSTEINE
01 1Germany
01 1Active
01 1Complete
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2013-04-03
DMF Number : 5836
Submission : 1985-03-29
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 N-ACETYL-L-CYSTEINE, with a corresponding US DMF Number 5836.
Remarkably, this DMF maintains an Active status since its submission on March 29, 1985, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 07, 2014, and payment made on April 03, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
