KEY PRODUCTS
Lundbeck CDM delivers end-to-end API and drug product solutions from development to commercial scale.
01 1Lundbeck CDM
01 1METOCLOPRAMIDE HCL MONOHYDRATE
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 : 2016-07-28
Pay. Date : 2016-07-21
DMF Number : 4877
Submission : 1983-03-26
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 METOCLOPRAMIDE HCL MONOHYDRATE, with a corresponding US DMF Number 4877.
Remarkably, this DMF maintains an Active status since its submission on March 26, 1983, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2016, and payment made on July 21, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
