KEY PRODUCTS
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
01 1ZOLPIDEM TARTRATE
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 : 2019-04-11
Pay. Date : 2019-04-05
DMF Number : 15486
Submission : 2001-06-21
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 ZOLPIDEM TARTRATE, with a corresponding US DMF Number 15486.
Remarkably, this DMF maintains an Active status since its submission on June 21, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 11, 2019, and payment made on April 05, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
