KEY PRODUCTS
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
01 1Polpharma
01 1APIXABAN
01 1Poland
01 1Active
01 1Complete
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-10
Pay. Date : 2016-12-20
DMF Number : 31166
Submission : 2016-11-16
Status : Active
Type : II
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Zaklady Farmaceutyczne Polpharma Sa, based in Poland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
One of their notable products is APIXABAN, with a corresponding US DMF Number 31166.
Remarkably, this DMF maintains an Active status since its submission on November 16, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 10, 2017, and payment made on December 20, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
