KEY PRODUCTS
Lundbeck CDM delivers end-to-end API and drug product solutions from development to commercial scale.
01 1Lundbeck CDM
01 1DIAZOXIDE
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 : 2017-06-02
Pay. Date : 2017-05-01
DMF Number : 7031
Submission : 1987-06-22
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 DIAZOXIDE, with a corresponding US DMF Number 7031.
Remarkably, this DMF maintains an Active status since its submission on June 22, 1987, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 02, 2017, and payment made on May 01, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
