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 1HYDROXYZINE PAMOATE
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 : 2013-09-28
Pay. Date : 2013-09-24
DMF Number : 4514
Submission : 1982-04-16
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 HYDROXYZINE PAMOATE, with a corresponding US DMF Number 4514.
Remarkably, this DMF maintains an Active status since its submission on April 16, 1982, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 28, 2013, and payment made on September 24, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
