KEY PRODUCTS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
01 1SEVELAMER HYDROCHLORIDE
01 1France
01 1Active
01 1Complete
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-20
Pay. Date : 2023-09-18
DMF Number : 38198
Submission : 2023-06-27
Status : Active
Type : II
20
Hvl Pharma Uk Limited, 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 SEVELAMER HYDROCHLORIDE, with a corresponding US DMF Number 38198.
Remarkably, this DMF maintains an Active status since its submission on June 27, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 20, 2023, and payment made on September 18, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
