What Altergon Italia does

Altergon Italia Srl Unipersonale is a privately-held Italian Contract Development and Manufacturing Organization (CDMO) headquartered in Morra De Sanctis (Avellino), with a registered office in Milan. Founded in 2001 by Swiss parent company Altergon SA, the company operates a 50,000 square-metre GMP-certified manufacturing campus comprising four dedicated production plants, two R&D laboratories (500 sqm), a biotech pilot plant (350 sqm), a medicated-plasters pilot plant (200 sqm), a Quality Control laboratory, and an automated warehouse for 7,000 pallets, with 15,000 sqm available for future expansion. Altergon holds ISO 9001:2015, ISO 14001:2015, ISO 13485:2016, and ISO 45001:2018 certifications, and is authorized by AIFA and the FDA under cGMP for production of impregnated-matrix medicated plasters, sterile pre-filled syringes, and APIs.

The company's product portfolio is built on two core technology platforms. First, transdermal and topical drug delivery systems — including hydrogel medicated patches, drug-in-adhesive matrix patches, double-layer matrix patches, microneedles, orodispersible films (ODF), and impregnated gauzes — produced under multi-year contract manufacturing arrangements with pharmaceutical multinationals. The hydrogel technology uses a watery matrix that adheres gently to skin and provides 12–24 hour controlled release without volatile organic solvents. Second, biotech production of ultrapure sodium hyaluronate under the Shyalt® sub-brand via a patented bacterial fermentation process (Streptococcus equi ssp. Zooepidemicus, non-GMO), with customizable molecular weight (40–3,000 kDa) and intrinsic viscosity (0.2–3.2 m³/kg). Shyalt® purity specifications exceed European Pharmacopoeia limits: bacterial endotoxins <0.005 I.U./mg versus 0.05 I.U./mg required, iron <10 ppm versus 80 ppm, protein <0.03% versus 0.1%.

Altergon generates revenue through four streams: CDMO contract manufacturing (multi-year quote-based contracts), Shyalt® API sales (one-time/license), Class I medical device manufacturing (single-use tubular elastic nets, medicated and balsamic plasters), and technology licensing/sub-licensing to pharmaceutical multinationals. The B2B go-to-market is executed through direct enterprise sales, with the Swiss parent Altergon SA (Lugano) handling general management and sales. Active geographic markets span Italy, Switzerland, the USA, Korea, Russia, China, and Japan, supported by regulatory approvals including CEP from EDQM (2014-263, latest revision March 2024), MAF to the FDA, KDMF from KFDA (March 2024), and Russian Ministry of Health registration. The company employs between 51 and 100 staff, with R&D at 5% of the workforce (50% PhD holders), and is expanding capacity under a 48.8 million EUR investment program partially funded by 33.8 million EUR of Invitalia incentives.

Name

Altergon Italia

Legal name

Altergon Italia Srl Unipersonale

Website

https://altergon.com

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

51–100 employees

Short description

Altergon Italia is a privately-held Italian CDMO specializing in transdermal drug delivery systems (hydrogel patches, drug-in-adhesive patches, microneedles, orodispersible films) and biotech production of ultrapure hyaluronic acid (Shyalt®), serving global pharmaceutical multinationals through contract manufacturing and API supply.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing & Drug Delivery Systems

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industries

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ), Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

Keywords

• Transdermal drug delivery
• Pharmaceutical contract manufacturing
• Hyaluronic acid production
• Medicated patches
• Biotech fermentation

Headquarters

HQ city

Morra De Sanctis

HQ country

Italy

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Manufacturing (CDMO): Contract development and manufacturing services for pharmaceutical companies, producing medicated plasters, transdermal patches, drug in adhesive patches, hydrogel medicated patches, ODF, PFS, medical devices, and QC analysis services.
2. Active Pharmaceutical Ingredients (API): Production and sale of ultrapure hyaluronic acid (sodium hyaluronate) as an API for pharmaceutical and medical use, including injectable, intra-articular, and intraocular applications.
3. Medical Device Manufacturing: Production of medical devices including single-use tubular elastic nets, medicated plasters, and balsamic plasters.
4. Technology Licensing and Sub-licensing: Products sub-licensed to pharmaceutical multinationals, with successful products leading to establishment of Altergon Italia in 2001.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Altergon Italia is a Contract Development & Manufacturing Organization (CDMO) that develops, manufactures, and licenses innovative drug delivery systems for pharmaceutical clients worldwide. Its core offerings include transdermal and topical delivery formats (medicated hydrogel patches, drug-in-adhesive matrix patches, double-layer matrix patches, microneedles, orodispersible films, impregnated gauzes) and a biotech division producing ultrapure sodium hyaluronate (Shyalt®) for pharmaceutical injectable, intra-articular, intraocular, and dermal filler applications, alongside Class I medical devices and sterile pre-filled syringe manufacturing.

Product overview

Altergon Italia is an innovative Contract Development and Manufacturing Organization (CDMO) serving pharmaceutical clients worldwide. Its core product portfolio centers on transdermal and topical drug delivery systems — encompassing medicated hydrogel patches, drug-in-adhesive matrix patches, double-layer matrix patches, microneedles, and orodispersible films (ODF) — alongside a dedicated biotech division producing ultrapure hyaluronic acid under the Shyalt® sub-brand. The company also manufactures Class I medical devices, impregnated gauzes, and sterile pre-filled syringes. All products are produced at the company's GMP-certified manufacturing campus in Morra De Sanctis, Italy, and are supported by in-house R&D, QC analysis, and secondary packaging services.

Differentiator

Problem solved

Functional benefit

Brands

• Shyalt® Ultrapure: Brand name for Altergon Italia's ultrapure biotech Sodium Hyaluronate for pharmaceutical and medical injectable applications.

Products and services

• Medicated Hydrogel Patch Water-based hydrogel matrix patch that gently adheres to the skin and provides controlled release of active ingredients over 12–24 hours; applicable for topical and transdermal drug delivery. Manufactured by Altergon as a contract development and manufacturing service for pharmaceutical clients.
• Drug in Adhesive Matrix Patch Thin, dry adhesive layer patch where the active ingredient is embedded directly in the adhesive; enables gradual drug release for both topical and systemic (transdermal) action. Produced by Altergon as a CDMO service for pharmaceutical companies.
• Double Layer Matrix Patch Multi-layer transdermal patch designed to accommodate drugs requiring separation of formulation components to achieve controlled release profiles. Produced by Altergon as a CDMO contract manufacturing service.
• Microneedles Microneedle-based transdermal delivery technology developed in Altergon's pilot laboratory for painless, minimally invasive administration of active pharmaceutical ingredients through the skin. Covered by Altergon patent.
• Impregnated Gauze Medicated gauze dressings impregnated with active pharmaceutical ingredients for wound care and topical treatment applications. Produced by Altergon as a CDMO offering.
• Orodispersible Films (ODF) Oral thin films that dissolve rapidly in the mouth for systemic drug delivery; Altergon produces ODF as a third-party contract manufacturing service for pharmaceutical clients.
• Class I Medical Devices (Single-use Tubular Elastic Nets and Medicated/Balsamic Plasters) Class I medical devices including single-use tubular elastic nets and medicated or balsamic plasters manufactured at Altergon's dedicated medical device production line under cGMP authorization.
• Shyalt® Ultrapure Hyaluronic Acid (Sodium Hyaluronate) Ultrapure biotech sodium hyaluronate produced via patented bacterial fermentation and purification process; molecular weight customizable between 40 and 3,000 kDa; suitable for injectable pharmaceutical and medical applications including intra-articular, intra-ocular, and cross-linking for dermal fillers. Sold under the Shyalt® Ultrapure sub-brand.
• Altergon Injectable Ultrapure Sodium Hyaluronate Brand-new European production plant dedicated to ultrapure injectable sodium hyaluronate (API); produced using non-GMO bacterial fermentation (Streptococcus equi ssp. Zooepidemicus); complies with EP, USP, Russia, JP pharmacopoeias; CEP 2014-263 Rev. 01 certified.
• Pre-filled Syringes (PFS) Manufacturing Service Sterile pre-filled syringe manufacturing service offered as part of Altergon's CDMO contract development and manufacturing capabilities for pharmaceutical clients.

Quantifiable outcome

• Production capacity exceeding 200 million units/year
• +4 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Università degli Studi della Campania Luigi Vanvitelli - Dipartimento di Medicina SperimentalecoreStrategic or Co-development Partner · 13 July 2017Academic partner in Industrial Research and Experimental Development project under Development Contract CDS_000463, collaborating on development of new matrices for innovative patches and new injectable fillers.
• Università degli Studi di Napoli Federico II - Dipartimenti di Scienze Chimiche e di FarmaciacoreStrategic or Co-development Partner · 13 July 2017Academic partner in research collaboration for development of innovative drug delivery systems and pharmaceutical formulations under Development Contract CDS_000463.
• Università degli Studi di Salerno - Dipartimento di FarmaciacoreStrategic or Co-development Partner · 13 July 2017Academic partner collaborating on pharmaceutical research and development of new drug delivery technologies under Development Contract CDS_000463.
• INBIOMED Project ConsortiumcoreStrategic or Co-development Partner · 13 July 2017R&D consortium for innovative biotechnological products for the biomedical sector (CUP: B26G18000360005). Funded under Research and Innovation 2014-2020 with total budget of 6.375 million EUR (Altergon portion: 2.004 million EUR). Consortium includes Tecnobios Srl, Technogenetics Spa, Università degli Studi del Sannio, Università degli Studi della Basilicata, and Università degli Studi di Padova.
• Bureau VeritascoreTechnology or IntegrationCertification body providing ISO 9001:2015, ISO 14001:2015, ISO 13485:2016, and ISO 45001:2018 certifications, as well as AEO (Authorized Economic Operator) certification for customs compliance.
• International Research NetworkminorStrategic or Co-development PartnerNetwork of techno-scientific partnerships with major research centres in national and international universities, centres of excellence and industrial partners in Europe, Russia, USA and Far East (China, Japan).
• Altergon SAcoreOthersSwiss parent company (based in Lugano) that established Altergon Italia in 2001 as a strategic production and R&D site following success of sub-licensed products. Altergon SA handles general management and sales operations.

Scale indicators10 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Tapemark: US-based CDMO specializing in transdermal patches, topical drug delivery, and medicated adhesives. Comparable niche contract manufacturer serving pharmaceutical companies with patch-based products.
• Kindeva Drug Delivery: Former 3M Drug Delivery Systems business; major CDMO for transdermal patches, inhalation, and microneedle drug delivery. Directly comparable on patch manufacturing technology stack and pharma client base.
• Nitto: Japanese diversified manufacturer with a Life Science CDMO arm producing transdermal patches, oral films, and advanced drug delivery formats. Comparable transdermal and ODF CDMO offerings serving global pharma.
• Stevanato Group: Italian pharmaceutical CDMO specializing in sterile injectables, pre-filled syringes, and glass containment. Overlaps directly with Altergon's PFS and injectable HA capabilities for pharma clients.
• Contipro: Czech biotech manufacturer of ultrapure hyaluronic acid and other polysaccharides for medical, cosmetic, and pharma applications. Most directly comparable peer for the Shyalt HA franchise.
• LTS Lohmann Therapie-Systeme: German-headquartered global leader in transdermal therapeutic systems and oral film CDMO services. Most directly comparable peer given shared focus on contract manufacturing of patches, ODF, and drug-in-adhesive systems for pharmaceutical clients.

Broad incumbents

• Recipharm: European-headquartered full-service CDMO covering APIs, sterile injectables, and finished dosage forms. Adjacent competitor for European pharma contract manufacturing work, including sterile fill-finish and biologics-related projects.
• Catalent: Large global CDMO offering softgel, oral, sterile injectable, and transdermal drug delivery services. Broader portfolio, but competes with Altergon for patch and PFS pharmaceutical contracts.
• Olon Group: Italian API manufacturer with a large portfolio of generic and biosimilar fermentation-derived and synthetic APIs. Comparable Italian-headquartered pharma manufacturer serving multinational drug companies under CDMO/CMO arrangements.
• Bloomage Biotech: Chinese global leader in hyaluronic acid manufacturing across cosmetic, medical, and pharmaceutical grades. Comparable biotechnology-based HA producer, though at a different scale and geographic footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/altergonitalia
• Facebookfacebook.com/altergonitalia
• LinkedInlinkedin.com/company/altergon-italia

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about Altergon Italia