KEY PRODUCTS
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
01 1DOFETILIDE
01 1Czech Republic
01 1Active
01 1Complete
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-06
Pay. Date : 2017-10-02
DMF Number : 31858
Submission : 2017-07-24
Status : Active
Type : II
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Farmak As, based in Czech Republic, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
One of their notable products is DOFETILIDE, with a corresponding US DMF Number 31858.
Remarkably, this DMF maintains an Active status since its submission on July 24, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 06, 2018, and payment made on October 02, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
