KEY PRODUCTS
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
01 1ZACH System SA
01 1BOSENTAN MONOHYDRATE
01 1France
01 1Active
01 1Complete
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-25
Pay. Date : 2014-01-31
DMF Number : 24929
Submission : 2011-05-09
Status : Active
Type : II
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Zach System Sa, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
One of their notable products is BOSENTAN MONOHYDRATE, with a corresponding US DMF Number 24929.
Remarkably, this DMF maintains an Active status since its submission on May 09, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 25, 2014, and payment made on January 31, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
