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01 1Cosma (C.F.M. Group)

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCosma 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 : 2015-01-29

Pay. Date : 2015-01-22

DMF Number : 4104

Submission : 1981-02-27

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 4104 of Cosma Spa

Looking for Drug Master Files (DMF) for 4104 of Cosma Spa 1

20

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 PROPRANOLOL HCL, with a corresponding US DMF Number 4104.

Remarkably, this DMF maintains an Active status since its submission on February 27, 1981, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 29, 2015, and payment made on January 22, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II