KEY PRODUCTS
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
01 1REGADENOSON
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 : 2021-02-18
Pay. Date : 2021-01-13
DMF Number : 35433
Submission : 2021-01-04
Status : Active
Type : II
20
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 REGADENOSON, with a corresponding US DMF Number 35433.
Remarkably, this DMF maintains an Active status since its submission on January 04, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 18, 2021, and payment made on January 13, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
