KEY PRODUCTS
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
01 1Laboratorium Ofichem B.V
01 1EDETATE CALCIUM DISODIUM
01 1Netherlands
01 1Active
01 1Complete
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-30
Pay. Date : 2022-08-03
DMF Number : 36993
Submission : 2022-07-13
Status : Active
Type : II
20
Laboratorium Ofichem Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
One of their notable products is EDETATE CALCIUM DISODIUM, with a corresponding US DMF Number 36993.
Remarkably, this DMF maintains an Active status since its submission on July 13, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 30, 2022, and payment made on August 03, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
