KEY PRODUCTS
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
01 1Polpharma
01 1RIVAROXABAN
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 : 2015-01-05
Pay. Date : 2014-11-21
DMF Number : 27661
Submission : 2013-10-21
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 RIVAROXABAN, with a corresponding US DMF Number 27661.
Remarkably, this DMF maintains an Active status since its submission on October 21, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2015, and payment made on November 21, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
