Italfarmaco

What Italfarmaco does

Italfarmaco is a privately held Italian multinational pharmaceutical group founded in 1938 and headquartered in Milan, with a diversified specialty pharma, rare disease, and consumer health portfolio. The company develops, manufactures, and commercializes branded prescription and consumer health products across six therapeutic areas: rare diseases (Duchenne muscular dystrophy, ALS, Polycythemia Vera), women's health, cardiometabolic, neurology and psychiatry, thrombosis, and consumer health. Its core scientific platform centers on proprietary HDAC (histone deacetylase) inhibitor chemistry, with givinostat (Duvyzat) representing the first pan-HDAC inhibitor approved by the FDA (March 2024) and EMA (June 2025) for Duchenne muscular dystrophy in patients aged six and older.

The commercial product portfolio includes Duvyzat (givinostat) for DMD, GhemaXan (Italy's first enoxaparin biosimilar launched 2019), Effik-branded women's health products (acquired 2015), and Lacer consumer health products (acquired 2022 for an undisclosed amount, contributing 1,300 Spain-based employees). The R&D pipeline includes ITF3756 (HDAC6 selective inhibitor in Phase 1 for solid tumors), ITF3912 (peptide-drug conjugate in preclinical), and antibody programs through Exiris. Manufacturing is anchored by a GMP-certified Milan plant with annual capacity of 80 million pre-filled syringes, with API production through group company Chemi.

Revenue is generated through three streams: branded prescription pharmaceuticals (specialty and rare disease), consumer health products through the Lacer and Effik brands, and biosimilars and generics, supplemented by licensing royalties from partnerships such as the JCR Pharmaceuticals agreement for Japan. The company operates an enterprise field sales model through 18+ wholly owned subsidiaries spanning Europe, North America, South America, the Middle East, and Asia, targeting specialist physicians (neurologists, cardiologists, gynecologists) and rare disease patient communities. Post-Lacer consolidated turnover exceeds 1 billion euros; the company employs approximately 3,500 people globally and will transition to a new CEO, Francesco Di Marco, effective January 1, 2026.

Name

Italfarmaco

Legal name

Italfarmaco S.p.A.

Website

https://italfarmaco.com

Company type

Private

Founded year

1938

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Italfarmaco is a privately held Italian multinational pharmaceutical group (founded 1938, Milan) that develops, manufactures, and commercializes specialty drugs, rare disease therapies, biosimilars, and consumer health products across Europe, the Americas, and Asia, with FDA/EMA-approved givinostat (Duvyzat) for Duchenne muscular dystrophy as its lead asset.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals (Rare Disease Therapeutics)

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Drugs and Druggists' Sundries Merchant Wholesalers (42421)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Specialty Care Pharmaceuticals (HLAIAAAB)

akta.pro secondary industries

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ), Cardiometabolic Pharmaceuticals (Cardiovascular/Diabetes/Obesity) (HLAIAAAE)

Keywords

• Rare disease therapeutics
• Specialty pharmaceuticals
• HDAC inhibitors
• Women's health products
• Biosimilar manufacturing

Headquarters

HQ city

Milan

HQ country

Italy

HQ region

Europe

Offices19 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations

Revenue model

1. Branded Prescription Pharmaceuticals: Revenue from proprietary prescription pharmaceutical products including Duvyzat (givinostat) for DMD, specialty products in women's health, cardiometabolic, neurology/psychiatry, and thrombosis therapeutic areas.
2. Consumer Health Products: Revenue from non-prescription consumer health products through Lacer brand in Spain and international markets, including personal hygiene and health supplements.
3. Generic and Biosimilar Products: Revenue from complex generics and biosimilars including enoxaparin, glatiramer, and pentosan developed and manufactured in-house.
4. Licensing and Commercialization Agreements: Revenue from licensing agreements such as the JCR Pharmaceuticals agreement for givinostat commercialization in Japan.

Go-to-market motion1 record

Distribution channels6 records

Marketing channels5 records

Core offering

Italfarmaco researches, develops, manufactures, and commercializes branded prescription and consumer health pharmaceutical products. Its portfolio includes specialty therapeutics for rare diseases (notably givinostat/Duvyzat for Duchenne muscular dystrophy), women's health products (via Effik), cardiometabolic, neurology/psychiatry, thrombosis treatments, and consumer health products (via Lacer). The company also develops and manufactures complex generics and biosimilars such as GhemaXan (enoxaparin biosimilar) through integrated R&D and GMP-certified manufacturing capabilities.

Product overview

Italfarmaco is a private multinational pharmaceutical group founded in 1938, based in Milan, Italy, producing high-quality medicinal specialties. The company's product portfolio centers on approved drugs including Duvyzat/Givinostat (HDAC inhibitor for Duchenne muscular dystrophy), GhemaXan (enoxaparin biosimilar), and Effik women's health products. The therapeutic portfolio spans rare diseases (DMD, ALS), women's health, cardiometabolic conditions, neurology/psychiatry, and thrombosis. Research pipeline includes HDAC inhibitors (ITF3756 for solid tumors), peptide-drug conjugates (ITF3912), and antibody programs for fibrosis. Consumer health is served through the acquired Lacer brand.

Differentiator

Problem solved

Functional benefit

Brands

• Duvyzat: FDA and EMA approved drug (givinostat) for treatment of Duchenne muscular dystrophy in patients six years and older
• GhemaXan
• EFFIK
• LACER

Products and services

• Duvyzat (givinostat) A pan-HDAC inhibitor approved by the FDA (March 2024) and European Commission (June 2025) for the treatment of Duchenne muscular dystrophy in patients six years of age and older. Also in Phase 3 development for Polycythemia Vera.
• GhemaXan The first biosimilar of Enoxaparin Sodium developed and produced in Italy. Indicated for treatment of deep vein thrombosis and pulmonary embolism, prophylaxis of venous thromboembolic disease, and prevention of thrombus formation during haemodialysis.
• Women's Health Products (Effik) Products addressing gynecological needs including contraception, vitamins and minerals for pregnancy, hormone replacement therapy, treatment of gynecological mycoses, luteal phase defect therapy, prevention of neural tube defects, and assisted reproduction. Sold under the Effik brand.
• Consumer Health Products (Lacer) Healthcare and personal hygiene products from acquired Spanish company Lacer, including products for consumer health and personal care marketed primarily in Spain and international markets.
• ALS Products Products for Amyotrophic Lateral Sclerosis including liquid formulations of Riluzole for treatment of ALS.
• Cardiometabolic Products
• Neurology and Psychiatry Products
• Thrombosis and Critical Ischemia Products
• ITF3756 (Pipeline - HDAC6 Inhibitor)
• ITF3912 (Pipeline - Peptide-Drug Conjugate)
• Mellozzan (melatonin) Melatonin sleep hormone product distributed by Italfarmaco in Italy under licensing agreement with EQL Pharma.

Quantifiable outcome

• Phase 3 EPIDYS trial demonstrated statistically significant and clinically meaningful treatment benefits in ambulant DMD patients aged 6 and older.
• +2 more outcomes

Named customers5 records

Segments7 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature5 records

Partnerships

Nine partnerships are on record, tiered minor, core and major.

• EQL PharmaminorOEM/ Whitelabel/ Licensing Partner · 25 March 2026Licensing agreement for distribution of Mellozzan (melatonin) sleep hormone product in Italy. Italfarmaco serves as the licensing partner for Italian market distribution.
• JCR PharmaceuticalscoreOEM/ Whitelabel/ Licensing Partner · 24 December 2025Exclusive licensing agreement for development and commercialization of givinostat in Japan for Duchenne muscular dystrophy treatment. Includes strategic collaboration to explore joint opportunities for treating rare diseases.
• Istituto RonzonimajorStrategic or Co-development Partner · 20 October 2025BioSpecNet scientific consortium for research. First private 800 MHz NMR in Italy to support rare disease research. Jointly managed NMR platform available to qualified research partners across Northern Italy.
• IktoscoreTechnology or Integration · 28 June 2024Strategic partnership to use Iktos' AI platforms (Makya for generative molecule design and Spaya for retrosynthetic analysis) to accelerate drug discovery for novel HDAC inhibitors in non-oncological fields. Combines AI technology with Italfarmaco's HDAC expertise.
• NeMO Center RomeminorStrategic or Co-development Partner · 23 June 2020Support for the 'Donnenmd' project providing training and information on neuromuscular pathologies with childhood onset and enhancing experiences of affected women and caregivers.
• Agostino Gemelli University Hospital Foundation IRCCSminorStrategic or Co-development Partner · 23 June 2020Collaboration partner in the 'Donnenmd' project for pediatric neuromuscular pathology training and information programs.
• TRiNDS (Therapeutic Research in Neuromuscular Disorders Solutions)majorStrategic or Co-development Partner · 9 November 2018Patient advocacy partnership for EPIDYS Phase 3 clinical trial of givinostat in the United States. TRiNDS provides patient outreach and education support for trial enrollment and retention.
• Exiris (Rome)minorStrategic or Co-development PartnerAntibody unit partnership for development of antibody drugs using novel phage display technology to identify fully human therapeutic monoclonal antibodies.
• ChemicoreStrategic or Co-development PartnerGroup company providing chemical development and manufacturing of active pharmaceutical ingredients. Leading active ingredient manufacturer within the Italfarmaco group.

Scale indicators9 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• Faes Farma: Spanish pharmaceutical company with specialty pharma, OTC, and consumer health operations. Comparable to Lacer's positioning within Italfarmaco's consumer health portfolio and similar European specialty pharma business model.
• Menarini Group: Italian private multinational pharmaceutical company with similar ownership structure, therapeutic breadth spanning specialty pharma, oncology, and consumer health, and global commercial presence across Europe, Americas, and Asia.
• PTC Therapeutics: Direct competitor in DMD with Translarna (ataluren) for nonsense mutation DMD. Competes in the same rare neuromuscular disease market with a similar specialty pharma commercial model targeting the same patient advocacy networks.
• Almirall: Spanish specialty pharmaceutical company focused on dermatology and specialty care with similar European mid-cap orientation and portfolio diversification across branded prescription products and consumer health.
• Chiesi Farmaceutici: Italian private multinational pharmaceutical company with parallel structure (private, family-controlled, founded in Parma). Operates specialty pharma portfolio across rare diseases, neonatology, and cardiometabolic with similar European geographic focus.
• Sarepta Therapeutics: Direct competitor in Duchenne muscular dystrophy with approved gene therapy Elevidys. Both companies target the same patient population with disease-modifying therapies for DMD, making it the closest direct comparable for Italfarmaco's Duvyzat franchise.
• Zambon: Italian private multinational pharmaceutical company with comparable private ownership structure, European specialty pharma focus, and respiratory/CNS therapeutic areas overlapping with Italfarmaco's neurology portfolio.
• Catalyst Pharmaceuticals: Specialty pharmaceutical company focused on rare diseases with a similar commercial model of targeting underserved patient populations with orphan drugs. Comparable in scale, regulatory focus, and go-to-market approach.
• Recordati: Italian multinational specialty pharmaceutical company headquartered in Milan with a similar European heritage, rare disease focus, and specialty therapeutic portfolio including women's health and cardiometabolic. Closest geographic and portfolio comparable.

Broad incumbents

• UCB: Belgian specialty pharmaceutical company with significant rare disease and neurology focus (including myasthenia gravis and epilepsy). Broader incumbent with overlapping capabilities in CNS and rare disease therapeutics relevant to Italfarmaco's ALS and DMD pipeline.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/italfarmaco

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries14 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Italfarmaco