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01 1Lundbeck CDM

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLundbeck CDM delivers end-to-end API and drug product solutions from development to commercial scale.

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-23

Pay. Date : 2013-02-21

DMF Number : 5900

Submission : 1985-04-22

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 5900 of Lundbeck Pharmaceuticals Italy Spa

Looking for Drug Master Files (DMF) for 5900 of Lundbeck Pharmaceuticals Italy Spa 1

20

Lundbeck Pharmaceuticals Italy Spa, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Lundbeck CDM delivers end-to-end API and drug product solutions from development to commercial scale.

One of their notable products is TRIMIPRAMINE MALEATE, with a corresponding US DMF Number 5900.

Remarkably, this DMF maintains an Active status since its submission on April 22, 1985, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 23, 2014, and payment made on February 21, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II