KEY PRODUCTS
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
01 1Egis Pharmaceuticals PLC
01 1PROMETHAZINE HCL
01 1Hungary
01 1Active
01 1Complete
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-10
Pay. Date : 2021-06-07
DMF Number : 7882
Submission : 1989-01-24
Status : Active
Type : II
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Egis Pharmaceuticals Plc, based in Hungary, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
One of their notable products is PROMETHAZINE HCL, with a corresponding US DMF Number 7882.
Remarkably, this DMF maintains an Active status since its submission on January 24, 1989, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 10, 2021, and payment made on June 07, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
