Archimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
01 1Archimica
01 1HYDROXYUREA
01 1Italy
01 1Active
01 1Complete
Archimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-13
Pay. Date : 2019-02-08
DMF Number : 12754
Submission : 1997-11-14
Status : Active
Type : II
20
Archimica Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for Archimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
One of their notable products is HYDROXYUREA, with a corresponding US DMF Number 12754.
Remarkably, this DMF maintains an Active status since its submission on November 14, 1997, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 13, 2019, and payment made on February 08, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
