Egis Pharmaceuticals DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

Corporate Presentation

FDF Product List 2025

API Product List 2025

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APIs Under Development 2025

Pharma Services

GMP Certificate 2024

NEWS #PharmaBuzz

Egis & the University of Szeged Expand Their Cooperation

05 Mar 2025

// PRESS RELEASE

Our project aimed at developing oncological active ingredients

24 Feb 2025

// PRESS RELEASE

Development Of High-Value Onco Drugs For Personalized Therapies

05 Feb 2025

// PRESS RELEASE

Egis is recognised as a Top Employer 2025 in Hungary

20 Jan 2025

// PRESS RELEASE

Egis Pharma Expands Its Portfolio with a Well-Known Product Line

16 Dec 2024

// PRESS RELEASE

2024 Hungarian Innovation Grand Prize Contest Kicks Off at Egis

07 Dec 2024

// PRESS RELEASE

ALL APIs

01

Promethazine Hydrochloride

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

USDMF

Click Us!

CEP/COS

JDMF

EU-WC NDC

KDMF VMF BR

AUDIT

02

Allopurinol

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

USDMF CEP/COS

JDMF

EU-WC NDC KDMF

VMF Others AUDIT

03

Chlorpromazine Hydrochloride

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

USDMF CEP/COS

JDMF

EU-WC NDC KDMF VMF ASMF, BR

AUDIT

04

Ethacrynic Acid

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

USDMF

CEP/COS

JDMF EU-WC NDC

KDMF VMF Others AUDIT

05

Amlodipine Besylate

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

USDMF CEP/COS

JDMF EU-WC NDC KDMF

VMF CN, BR

AUDIT

06

Aripiprazole

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

USDMF CEP/COS

JDMF EU-WC NDC KDMF VMF Others AUDIT

07

Bisoprolol Fumarate

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

USDMF CEP/COS

JDMF EU-WC NDC KDMF VMF Others AUDIT

08

Levomepromazine Maleate

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

USDMF CEP/COS

JDMF EU-WC NDC KDMF VMF ASMF, BR

AUDIT

09

Methyldopa

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

USDMF CEP/COS

JDMF EU-WC NDC KDMF VMF Others AUDIT

10

Nitrendipine

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

USDMF CEP/COS

JDMF EU-WC NDC KDMF VMF Others AUDIT

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USDMF

01

Ethacrynic Acid

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17193

Submission : 2004-02-26

Status : Active

Type : II

02

Promethazine Hcl

Hungary

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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CEP/COS

01

Allopurinol

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Certificate Numbers : R1-CEP 1996-032 - Rev 05

Status : Valid

Issue Date : 2019-08-09

Type : Chemical

Substance Number : 576

02

Allopurinol, Synthetic route B

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Certificate Numbers : CEP 2014-364 - Rev 01

Status : Valid

Issue Date : 2023-11-27

Type : Chemical

Substance Number : 576

03

Amlodipine besilate, Synthesis B process...

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Certificate Numbers : CEP 2023-411 - Rev 00

Status : Valid

Issue Date : 2024-06-14

Type : Chemical

Substance Number : 1491

04

Amlodipine besilate, Synthetic route B

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Certificate Numbers : R1-CEP 2007-185 - Rev 02

Status : Valid

Issue Date : 2016-12-19

Type : Chemical

Substance Number : 1491

05

Aripiprazole

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Certificate Numbers : R1-CEP 2014-252 - Rev 02

Status : Valid

Issue Date : 2022-07-21

Type : Chemical

Substance Number : 2617

06

Bisoprolol fumarate

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Certificate Numbers : R0-CEP 2019-090 - Rev 00

Status : Valid

Issue Date : 2021-03-16

Type : Chemical

Substance Number : 1710

07

Carvedilol

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Certificate Numbers : R1-CEP 2003-042 - Rev 03

Status : Valid

Issue Date : 2019-02-20

Type : Chemical

Substance Number : 1745

08

Carvedilol, Synthetic route B

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Certificate Numbers : R1-CEP 2016-314 - Rev 00

Status : Valid

Issue Date : 2023-08-28

Type : Chemical

Substance Number : 1745

09

Chlorpromazine hydrochloride

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Certificate Numbers : R1-CEP 1996-077 - Rev 07

Status : Valid

Issue Date : 2021-10-15

Type : Chemical

Substance Number : 475

10

Duloxetine hydrochloride

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Certificate Numbers : CEP 2023-144 - Rev 00

Status : Valid

Issue Date : 2024-12-19

Type : Chemical

Substance Number : 2594

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JDMF

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KDMF

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NDC API

Only 10 entries up to this point, click to access all

VMF

Only 10 entries up to this point, click to access all

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LISTED APIs

01

Abemaciclib

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its products under Egis�...

02

Abrocitinib

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

03

Acalabrutinib

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

04

Alectinib

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

05

Allopurinol

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

06

Amlodipine Besilate

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

07

Avapritinib

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

08

Bisoprolol Fumarate

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

09

Blarcamesine

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

10

Carvedilol

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Only 10 entries up to this point, click to access all

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Drugs in Development

01 Egis Pharmaceuticals PLC

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Lead Product(s) : Favipiravir

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : National Institute of Pharmacy and Nutrition

Deal Size : Inapplicable

Deal Type : Inapplicable

DEALS_DEV

Egis Favipiravir Drug Licenced for Covid-19 Treatment

Details : The active ingredient favipiravir manufactured by Hungarian pharmaceutical company Egis has been licenced for treatment of Covid-19 by the National Institute of Pharmacy and Nutrition (OGYÉI).

Product Name : Favipiravir-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 20, 2020

Data Compilation
#PharmaFlow

Virtual Booth

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FDF Dossiers

01

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

02

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

03

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

04

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

05

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

06

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

07

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

08

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

09

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Capsule

Dosage Strength : 20MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

10

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Capsule

Dosage Strength : 10MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Only 10 entries up to this point, click to access all

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Listed Dossiers

01

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

02

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

03

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

04

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

05

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

06

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

07

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

08

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Tablet

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

09

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Capsule

Dosage Strength : 10MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

10

Brand Name : N/A

Hungary

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Regulatory Info :

Registration Country : Hungary

Dosage Form : Capsule

Dosage Strength : 20MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary