Lundbeck CDM delivers end-to-end API and drug product solutions from development to commercial scale.
KEY PRODUCTS
KEY SERVICES
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01 1Lundbeck CDM
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01 1TRIMIPRAMINE MALEATE
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01 1Denmark
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01 1Active
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01 1Complete
Lundbeck 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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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