Archimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
01 1Archimica
01 1CYTARABINE
01 1Italy
01 1Active
01 1Complete
Archimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-18
Pay. Date : 2013-01-15
DMF Number : 25267
Submission : 2011-09-07
Status : Active
Type : II
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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 CYTARABINE, with a corresponding US DMF Number 25267.
Remarkably, this DMF maintains an Active status since its submission on September 07, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 18, 2013, and payment made on January 15, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
