EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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01 1EUROAPI
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01 1LATANOPROST
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01 1France
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-11
Pay. Date : 2013-01-16
DMF Number : 26728
Submission : 2012-12-14
Status : Active
Type : II
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Euroapi Hungary Ltd, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
One of their notable products is LATANOPROST, with a corresponding US DMF Number 26728.
Remarkably, this DMF maintains an Active status since its submission on December 14, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 11, 2013, and payment made on January 16, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II