KEY PRODUCTS
Lundbeck CDM delivers end-to-end API and drug product solutions from development to commercial scale.
01 1Lundbeck CDM
01 1ARGATROBAN
01 1Denmark
01 1Active
01 1Complete
Lundbeck CDM delivers end-to-end API and drug product solutions from development to commercial scale.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-26
DMF Number : 21304
Submission : 2008-01-30
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 ARGATROBAN, with a corresponding US DMF Number 21304.
Remarkably, this DMF maintains an Active status since its submission on January 30, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 05, 2013, and payment made on September 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
