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 1DIMETHYL FUMARATE
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 : 2017-02-21
Pay. Date : 2016-10-26
DMF Number : 31053
Submission : 2017-01-12
Status : Active
Type : II
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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 DIMETHYL FUMARATE, with a corresponding US DMF Number 31053.
Remarkably, this DMF maintains an Active status since its submission on January 12, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 21, 2017, and payment made on October 26, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
