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

Click the button for full data set

APIs Under Development 2025

Pharma Services

GMP Certificate 2024

DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

During the second quarter (Q2) of 2025, contract development and manufacturing organizations (CDMOs) made substantial investments in specialized therapeutic manufacturing. The quarter also saw CDMOs pursue high-value, complex manufacturing niches, particularly in antibody-drug conjugates (ADCs), cell and gene therapies (CGTs) and oligonucleotides.Alongside these trends, Q2 also saw CDMOs strengthen their footprint in the United States amid concerns over rising tariffs and unpredictable trade policies being enforced by the Trump administration.Regeneron Pharmaceuticals committed over US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to nearly double its US manufacturing capacity for biologics. Under this agreement, Fujifilm will manufacture and supply drug products for Regeneron at its large-scale facility in Holly Springs, North Carolina.Thermo Fisher Scientific announced plans to invest an additional US$ 2 billion in the US over four years, reinforcing its manufacturing and R&D capabilities. With 64 facilities spread across 37 states, Thermo Fisher aims to bolster American innovation and competitiveness. Similarly, Piramal Pharma announced a US$ 90 million investment plan for expanding two facilities in the US, thereby bringing its total investment in the country to US$ 570 million. View CDMO Activity Tracker for Q2 2025 (Free Excel Available)Veranova, Carbogen lead ADC wave; Axplora doubles down on HPAPI production in ItalyThe quarter saw substantial investments in ADC manufacturing. Veranova announced a US$ 20 million investment in bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. With this investment, Veranova will be able to provide a more comprehensive suite of services to its partners developing ADCs and other bioconjugates. Veranova’s total investment in the Devens facility now stands at over US$ 50 million. Swiss CDMO Carbogen announced a US$ 31 million co-investment with an unnamed Japanese investor to expand its capabilities across its Aarau and Neuland (Switzerland) facilities. The facility will address increasing demand for complex and high-value compounds such as ADC drug linkers.Axplora announced a further €35 million (US$ 41 million) expansion of its Farmabios site in Italy, doubling the facility to approximately 108,000 square meters by mid-2026. This investment raises its total spend on the site to over €80 million (US$ 94.05 million) since 2019, supporting the production of highly potent active pharmaceutical ingredients (HPAPIs). Farmabios now stands as a key hub in Axplora’s global CDMO network.Polish pharmaceutical manufacturer Polfa Tarchomin is positioning itself as a significant player in the European CDMO market through its investment in the Center for Development and Production of Highly Potent Drugs. This 12,000 square meter facility has two state-of-the-art production lines designed for filling vials and pre-filled syringes with an annual capacity of 26 million product units.Skyepharma’s projected annual revenues from oncology-linked activities touched €10 million (US$ 11.2 million). The CDMO’s facility in Saint-Quentin-Fallavier is equipped to handle cytotoxic and cytostatic compounds, and is one of the few facilities in France capable of managing HPAPIs for oral anticancer treatments. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Athena acquires Medipha Santé, Famar buys MiP Pharma’s German site to strengthen European footprintDuring the quarter, several CDMOs enhanced their strategic capabilities through M&As. Athena Pharmaceutiques acquired Medipha Santé to build a fully integrated pharmaceutical services platform in Europe. Based in Paris, Athena has strengthened its commercial and regulatory toolbox by bringing aboard Medipha Santé’s 35-strong team, which supports over 100 partner organizations and files approximately 350 dossiers annually with ANSM and other European agencies. With this integration, Athena positions itself as a one-stop CDMO partner.With the acquisition of MiP Pharma’s sterile manufacturing site in Homburg, Germany, the Famar Group has expanded its capabilities in aseptic and lyophilized fill-and-finish operations. The acquisition has strengthened Famar’s position in sterile drug manufacturing. The CDMO now has seven manufacturing facilities in Europe.PCI Pharma Services’ acquisition of Ajinomoto Althea has established a world-class, large-scale manufacturing hub in the San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high-potent formulations such as ADCs. PCI Pharma is now amongst the few US-based CDMOs capable of comprehensive ADC manufacturing.Samsung Biologics’ strategic spinoff of its biosimilar business stood out as a significant corporate restructuring exercise during the quarter. The separation of Samsung Bioepis, tentatively renamed Samsung Epis Holdings, aims to enhance Samsung Biologics’ strategic focus and build client trust, as it eliminates potential conflicts between CDMO services and proprietary drug development. The move came after Samsung Biologics inked a contract worth 737.3 billion Korean won (US$ 518 million) with an undisclosed US pharmaceutical company.WuXi Biologics announced a US$ 167 million divestment of its German facility to Terumo and broke ground on a microbial production plant in China. National Resilience, which was launched five years ago as the US drug manufacturer dedicated to broadening access to medicines and protecting biopharma supply chains, said it is shuttering six of its 10 facilities. The company said the sites were “not being fully utilized.” View CDMO Activity Tracker for Q2 2025 (Free Excel Available) MilliporeSigma, Simtra form 5-year ADC alliance; Silexion partners Catalent for siRNA developmentMerck KGaA’s MilliporeSigma and Simtra struck a five-year strategic alliance, combining expertise across the ADC value chain to reduce development timelines and complexity for biopharmaceutical companies. Viralgen collaborated with Trogenix to rapidly scale product supply for TGX-007, an AAV gene therapy for glioblastoma (a type of cancer of the brain and spinal cord). Silexion announced a collaboration with Catalent for small interfacing RNA (siRNA) development and manufacturing. Catalent’s Limoges (France) facility will conduct formulation development and clinical manufacturing for Silexion’s SIL204 candidate, supporting both systemic and intra-tumoral delivery formulations.Skyepharma’s collaboration with Eneapharm through the Skyehub platform aims to support the treatment of patients suffering from exocrine pancreatic insufficiency, including those affected by cystic fibrosis or pancreatic cancer. Orion Corporation reached an agreement with Shilpa Biocare for the distribution of recombinant human albumin in Europe.Meanwhile, Aenova announced the launch of its Aenovation program, an initiative designed to fast-track early development of pharmaceutical formulations. The program addresses the critical challenges of bioavailability and time-to-market faced by poorly soluble drug candidates. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Our view The quarter saw CDMO developments mimic the broader trends in the pharmaceutical industry, such as onshoring of critical manufacturing capabilities in the US, consolidation of specialized expertise through strategic partnerships, and the relentless focus on emerging therapeutic modalities that promise to transform patient care. With CDMOs continuing to invest in next-generation manufacturing capabilities, we expect the sector to play a crucial role in drug innovation.

Impressions: 1163

NEWS #PharmaBuzz

Hungarian Pharma Giants May Begin Uzbekistan Production

24 Jun 2025

// PRESS RELEASE

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

ALL APIs

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

CEP/COS

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

JDMF

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

KDMF

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

LISTED APIs

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Virtual Booth

FDF Dossiers

01

Brand Name : Abemaciclib

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 : Abemaciclib

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

03

Brand Name : Abemaciclib

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

04

Brand Name : Abemaciclib

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 : Aripiprazole

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

06

Brand Name : Aripiprazole

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

07

Brand Name : Aripiprazole

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 : Aripiprazole

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

09

Brand Name : Atorvastatin ; Ezeti...

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 : 20MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

10

Brand Name : Atorvastatin ; Ezeti...

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

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Dossiers

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

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.

Service
Web Link

Capabilities
#ServicesBio

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Small Molecules

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

GMP Manufacturing

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Small Scale Batch

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Contract Manufacturing

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

High Potency APIs (HPAPIs)

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Fine Chemical / Intermediate

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API & Drug Product Development

Discover their expertise for :

API Development

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

KEY SERVICES

TOP RANKED SUPPLIER FOR:

Inspections and registrations

Check the inspections & registration from this company

FDA

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

EDQM

01

GMP Certified

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

Type : GMP Certificates

Number : NNGYK/GYSZ/...

EudraGMDP Key : 172300

Country : Hungary

Issue Date : 2024-09-27

Post Code :

NCA Ref : HU-A-EGIS01

City : Budapest X

Product
Web Link

02

GMP Certified

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

Type : GMP Certificates

Number : NNGYK/GYSZ/...

EudraGMDP Key : 171173

Country : Hungary

Issue Date : 2024-07-25

Post Code :

NCA Ref : HU-D-EGIS02

City : Budapest Xv

Product
Web Link

03

GMP Certified

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

Type : GMP Certificates

Number : NNGYK/GYSZ/...

EudraGMDP Key : 170312

Country : Hungary

Issue Date : 2024-06-13

Post Code :

NCA Ref : HU-D-EGIS02

City : Budapest Xv

Product
Web Link

04

GMP Certified

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

Type : GMP Certificates

Number : NNGYK/GYSZ/...

EudraGMDP Key : 169010

Country : Hungary

Issue Date : 2024-04-15

Post Code :

NCA Ref : HU-M-EGIS04

City : Kormend

Product
Web Link

05

GMP Certified

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

Type : GMP Certificates

Number : NNGYK/GYSZ/...

EudraGMDP Key : 169009

Country : Hungary

Issue Date : 2024-04-15

Post Code :

NCA Ref : HU-A-EGIS01

City : Kormend

Product
Web Link

06

GMP Certified

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

Type : GMP Certificates

Number : NNGYK/GYSZ/...

EudraGMDP Key : 167819

Country : Hungary

Issue Date : 2024-02-22

Post Code :

NCA Ref : HU-A-EGIS01

City : Budapest X

Product
Web Link

07

GMP Certified

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

Type : GMP Certificates

Number : OGY

EudraGMDP Key : 159029

Country : Hungary

Issue Date : 2023-03-16

Post Code :

NCA Ref : HU-M-EGIS07

City : Budaors

Product
Web Link

08

GMP Certified

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

Type : GMP Certificates

Number : OGY

EudraGMDP Key : 155131

Country : Hungary

Issue Date : 2022-12-07

Post Code :

NCA Ref : HU-D-EGIS01

City : Budapest XVI

Product
Web Link

09

GMP Certified

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

Type : GMP Certificates

Number : OGY

EudraGMDP Key : 145525

Country : Hungary

Issue Date : 2022-03-17

Post Code :

NCA Ref : HU-D-EGIS01

City : Budapest XVI

Product
Web Link

10

GMP Certified

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

Type : GMP Certificates

Number : OGY

EudraGMDP Key : 142561

Country : Hungary

Issue Date : 2021-12-14

Post Code :

NCA Ref : HU-M-EGIS05

City : Buda

Product
Web Link