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 1RANOLAZINE
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 : 2014-02-10
Pay. Date : 2013-02-05
DMF Number : 22811
Submission : 2009-06-15
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 RANOLAZINE, with a corresponding US DMF Number 22811.
Remarkably, this DMF maintains an Active status since its submission on June 15, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 10, 2014, and payment made on February 05, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
