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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 : 2017-05-18

Pay. Date : 2017-02-02

DMF Number : 31327

Submission : 2017-03-16

Status : Active

Type : II

Company Banner

Looking for Drug Master Files (DMF) for 31327 of Cosma Spa

Looking for Drug Master Files (DMF) for 31327 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 LEVOMILNACIPRAN HYDROCHLORIDE, with a corresponding US DMF Number 31327.

Remarkably, this DMF maintains an Active status since its submission on March 16, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 18, 2017, and payment made on February 02, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II