KEY PRODUCTS
Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.
01 1Cosma (C.F.M. Group)
01 1CETIRIZINE DIHYDROCHLORIDE
01 1Italy
01 1Active
01 1Complete
Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-10
Pay. Date : 2024-07-05
DMF Number : 20309
Submission : 2007-02-21
Status : Active
Type : II
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Cosma Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.
One of their notable products is CETIRIZINE DIHYDROCHLORIDE, with a corresponding US DMF Number 20309.
Remarkably, this DMF maintains an Active status since its submission on February 21, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 10, 2024, and payment made on July 05, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
