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

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

Development Of High-Value Onco Drugs For Personalized Therapies

05 Feb 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

Csaba Poroszlai Speaks on Pharma Industry Competitiveness

29 Nov 2024

// PRESS RELEASE

Agreement for Biosimilar in Key Central & Eastern EU Markets

12 Nov 2024

// PRESS RELEASE

Egis's Celebrates 10-Y Partnership With Kormend Basketball Team

19 Oct 2024

// PRESS RELEASE

ALL APIs

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USDMF

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CEP/COS

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JDMF

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KDMF

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NDC API

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VMF

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LISTED APIs

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Drugs in Development

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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 : 150MG

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 : 200MG

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 : 50MG

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 : 15MG

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 : 10MG

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

Atorvastatin; Ezetimibe

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

Atorvastatin; Ezetimibe

Dosage Form : Capsule

Dosage Strength : 40MG; 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

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KEY PRODUCTS

TOP RANKED SUPPLIER FOR:

Services

Discover the service capabilities from this company

API Manufacturing

Discover their expertise for :

Clinical Supply

01

HPAPIs FOR CLINICAL TRIALS

Hungary

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

Pharma Service : API Manufacturing

Egis Pharmaceuticals is a contract development and manufacturing organization (CDMO) that can produce highly potent APIs for clinical trials, formulation experiments, and commercial purposes.

Category : Clinical Supply

Sub Category : Overview

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

Pharma Service : API Manufacturing

HPAPIs FOR CLINICAL TRIALS

Egis Pharmaceuticals is a contract development and manufacturing organization (CDMO) that can produce highly potent APIs for clinical trials, formulation experiments, and commercial purposes.

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Small Molecules

01

CMO FOR SMALL MOLECULES

Hungary

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

Pharma Service : API Manufacturing

From 2023, Egis offers a wide range of small molecule drug substance development and manufacturing services to pharmaceutical partners.

Category : Small Molecules

Sub Category : Overview

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

Pharma Service : API Manufacturing

CMO FOR SMALL MOLECULES

From 2023, Egis offers a wide range of small molecule drug substance development and manufacturing services to pharmaceutical partners.

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GMP Manufacturing

01

API GMP MANUFACTURING

Hungary

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

Pharma Service : API Manufacturing

Egis Pharmaceuticals offers the manufacturing of active pharmaceutical ingredients and intermediates with organic chemical synthesis on a large-scale under cGMP regulations. It also has highly potent GMP lines for the production of HPAPIs.

Category : GMP Manufacturing

Sub Category : Active Pharmaceutical Ingredients

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

Pharma Service : API Manufacturing

API GMP MANUFACTURING

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Small Scale Batch

01

SMALL BATCH API MANUFACTURING

Hungary

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

Pharma Service : API Manufacturing

Egis Pharmaceuticals is a contract development and manufacturing organization (CDMO) that produces a wide range of active pharmaceutical ingredients (APIs) in small batches.

Category : Small Scale Batch

Sub Category : Overview

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

Pharma Service : API Manufacturing

SMALL BATCH API MANUFACTURING

Egis Pharmaceuticals is a contract development and manufacturing organization (CDMO) that produces a wide range of active pharmaceutical ingredients (APIs) in small batches.

Capabilities
#ServicesBio

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Contract Manufacturing

01

API CONTRACT MANUFACTURING

Hungary

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

Pharma Service : API Manufacturing

Egis Pharmaceuticals involves contract manufacturing of active pharmaceutical ingredients & intermediates using organic chemical synthesis on large-scale production lines. It can produce a wide range of APIs including highly potent APIs & small molecules.

Category : Contract Manufacturing

Sub Category : Overview

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

Pharma Service : API Manufacturing

API CONTRACT MANUFACTURING

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High Potency APIs (HPAPIs)

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Fine Chemical / Intermediate

01

MANUFACTURING OF INTERMEDIATES &...

Hungary

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

Pharma Service : API Manufacturing

Egis offers a wide range of intermediate and small molecule drug substance development and manufacturing services to its pharmaceutical partners. Its multifunctional production lines utilizes organic synthesis process for intermediates & drug substances.

Category : Fine Chemical / Intermediate

Sub Category : Overview

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

Pharma Service : API Manufacturing

MANUFACTURING OF INTERMEDIATES & APIs

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API & Drug Product Development

Discover their expertise for :

API Development

01

CDMO FOR SMALL MOLECULES

Hungary

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

Pharma Service : API & Drug Product Development

Egis Pharmaceuticals is a CDMO that offers development and manufacturing services for a variety of small molecule drug substances and intermediates to its pharmaceutical partners.

Category : API Development

Sub Category : Small Molecules

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

Pharma Service : API & Drug Product Development

CDMO FOR SMALL MOLECULES

Egis Pharmaceuticals is a CDMO that offers development and manufacturing services for a variety of small molecule drug substances and intermediates to its pharmaceutical partners.

02

CDMO FOR INTERMEDIATES & APIs

Hungary

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

Pharma Service : API & Drug Product Development

Egis Pharmaceuticals is a CDMO which is involved in the chemical process development & manufacturing of intermediates & drug substances from 100 g to 2 kg. It has dedicated analytical laboratories for highly potent (HP) intermediates and drug substances.

Category : API Development

Sub Category : Fine Chemical / Intermediate

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

Pharma Service : API & Drug Product Development

CDMO FOR INTERMEDIATES & APIs

03

CDMO FOR HIGHLY POTENT DRUG SUBS...

Hungary

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

Pharma Service : API & Drug Product Development

Egis Pharmaceuticals has cutting-edge infrastructure for the contract development of traditional and highly potent (HP) drug substances. It involves the synthesis and scale-up to a maximum 15 L volume with OEB4 classification 1 g/m3 < OEL < 10 g/m3.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

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

Pharma Service : API & Drug Product Development

CDMO FOR HIGHLY POTENT DRUG SUBSTANCES

04

HIGHLY POTENT APIs FOR CLINICAL ...

Hungary

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

Pharma Service : API & Drug Product Development

Egis Pharmaceuticals is a CDMO that is engaged in highly potent drug substance development and production for clinical trials, formulation experiments, and commercial purposes.

Category : API Development

Sub Category : Clinical Supply

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

Pharma Service : API & Drug Product Development

HIGHLY POTENT APIs FOR CLINICAL TRIALS

Egis Pharmaceuticals is a CDMO that is engaged in highly potent drug substance development and production for clinical trials, formulation experiments, and commercial purposes.

05

API SCALE-UP

Hungary

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

Pharma Service : API & Drug Product Development

Egis Pharmaceuticals has the capacity to scale up the chemical process development for drug substances and intermediates to a maximum of 20 L volume. It can also develop and scale up highly potent APIs up to 15 L volumes.

Category : API Development

Sub Category : Scale-Up Capabilities

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

Pharma Service : API & Drug Product Development

API SCALE-UP

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KEY SERVICES

TOP RANKED SUPPLIER FOR:

Inspections and registrations

Check the inspections & registration from this company

FDA

01 FDA Audited

USA

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

District Decision : No Action Indicated

Inspection End Date : 2018-06-08

City : Budapest

State :

Country/Area : HU

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2018-06-08

Product
Web Link

02 FDA Audited

USA

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

District Decision : No Action Indicated

Inspection End Date : 2014-12-18

City : Kormend

State :

Country/Area : HU

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-12-18

Product
Web Link

03 FDA Audited

USA

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

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-12-12

City : Budapest Xvii

State :

Country/Area : HU

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-12-12

Product
Web Link

04 FDA Audited

USA

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

District Decision : No Action Indicated

Inspection End Date : 2013-11-08

City : Budapest

State :

Country/Area : HU

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-11-08

Product
Web Link

05 FDA Audited

USA

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

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-01-28

City : Budapest

State :

Country/Area : HU

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-01-28

Product
Web Link

06 FDA Audited

USA

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

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-01-28

City : Kormend

State :

Country/Area : HU

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-01-28

Product
Web Link

07 FDA Audited

USA

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

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-01-28

City : Budapest Xvii

State :

Country/Area : HU

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-01-28

Product
Web Link