Farmasol

What Farmasol does

Farmasol Srl is an Italian privately held Contract Manufacturing Organization (CMO) founded in 2005 in Balvano, Province of Potenza, specializing in the development, registration, and production of concentrate solutions for haemodialysis. The company operates a single GMP-compliant production plant covering 3,000 square meters on an 11,000 square meter industrial site in Baragiano Scalo, with ISO7-classified clean rooms used for dispensing, mixing, and filling operations. Its product portfolio comprises three medical-device lines — haemodialysis solutions based on acetic acid, hydrochloric acid (acetate-free), and citric acid — all formulated to European Pharmacopeia standards and certified under EU Medical Device Regulation 2017/745. Products are offered in flexible configurations (rigid or flexible containers, PVC or PVC-free, 1 to 5.4 liter volumes) with multiple closure systems, and the company is developing a recyclable monolayer polyolefin container (SBS ONE) via an EU-funded co-development partnership.

The company's business model is B2B contract manufacturing: Farmasol sells formulation development, registration support (including stability studies and clinical trial batches), and commercial-scale production to pharmaceutical-industry clients under long-term manufacturing agreements, with pricing determined per quote based on formulation complexity, volume, and contract terms. Customers are described as "main players in the field of Haemodialysis Therapies." Quality and regulatory positioning is the core commercial anchor — over 15 years of GMP compliance history, ISO 9001 and ISO 13485 certifications, and EU MDR product certification, with annual audits by Notified Bodies and clients. Revenue, headcount, and customer count are not publicly disclosed. The company is founder-family controlled (Dr. Vito Miraglia founded it; his son Enio Miraglia, a Management Engineering graduate, has run operations since 2011), with no external institutional investors, parent company, or public listing identified.

Name

Farmasol

Legal name

Farmasol Srl

Website

https://farmasol.it

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

Farmasol Srl is a privately held Italian Contract Manufacturing Organization founded in 2005, producing GMP-compliant haemodialysis concentrate solutions (acetic, hydrochloric, and citric acid formulations) for pharmaceutical-industry clients from its Balvano facility.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing (Haemodialysis Solutions)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL)

akta.pro secondary industry

Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM)

Keywords

• Haemodialysis concentrate solutions
• Pharmaceutical contract manufacturing
• GMP-compliant CMO services
• Medical device manufacturing
• Dialysis solution production

Headquarters

HQ city

Balvano

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Manufacturing Services: Farmasol operates as a CMO (Contract Manufacturing Organization) providing pharmaceutical industries with development, registration, and production services for haemodialysis concentrate solutions. Revenue is generated through long-term manufacturing contracts with pharmaceutical companies, including custom formulation development, pilot batch production, stability studies for registrations, and clinical trial batch production.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Farmasol Srl is a full-service pharmaceutical Contract Manufacturing Organization (CMO) specializing in the development, registration, and production of concentrate solutions for haemodialysis. The company manufactures three acid-based formulations (acetic acid, hydrochloric acid/acetate-free, and citric acid) packaged in flexible or rigid containers from 1 to 5.4 litres, serving pharmaceutical industry clients under GMP, ISO 9001, ISO 13485, and EU MDR 2017/745 compliance.

Product overview

Farmasol is a full-service pharmaceutical CMO (Contract Manufacturing Organization) specializing in the development, registration, and production of concentrate solutions for haemodialysis. The product portfolio consists of three main Medical Device product lines — Haemodialysis Solutions with Acetic Acid, Haemodialysis Solutions with Hydrochloric Acid (Acetate Free), and Haemodialysis Solutions with Citric Acid — all meeting European Pharmacopeia standards and CE Marking requirements under Medical Device Directive 93/42/EEC. Products are manufactured in volumes from 1 to 5.4 litres using various primary containers (rigid/flexible, PVC/PVC-free) with multiple closure systems. The company also maintains an R&D project for a new 'SBS ONE' monolayer polyolefin container. Farmasol operates as a CMO partner serving pharmaceutical industries, providing services from product formulation through industrialization, including pilot batches, stability studies, clinical trial batch production, and process/method validation.

Differentiator

Problem solved

Functional benefit

Products and services

• Haemodialysis Solutions with Acetic Acid Concentrate solutions for haemodialysis containing acetic acid, classified as Medical Devices meeting European Pharmacopeia requirements and Medical Device Directive 93/42/EEC for CE Marking. Manufactured under GMP in ISO7 clean rooms and supplied to pharmaceutical companies as a CMO-produced product line.
• Haemodialysis Solutions with Hydrochloric Acid (Acetate Free) Acetate-free concentrate solutions for haemodialysis using hydrochloric acid, meeting European Pharmacopeia standards and Medical Device Directive 93/42/EEC for CE Marking. Formulated for patients requiring alternatives to acetate-based solutions.
• Haemodialysis Solutions with Citric Acid Concentrate solutions for haemodialysis containing citric acid, classified as Medical Devices meeting European Pharmacopeia requirements and Medical Device Directive 93/42/EEC for CE Marking.

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• Advanced Polymer Materials (APM) S.R.L.coreStrategic or Co-development PartnerJoint R&D partnership with APM S.R.L. and C.S.G.I. Research Organization to develop new polymer blends for eco-sustainable medical bags for injectable liquids. Project supported by European Regional Development Fund (PON - Axis 1 Investment priority 1.b Action 1.1.3 TR). The project aims to develop recyclable bags using thermoplastic elastomers (TPE-O, TPE-S, TPE-P) as alternatives to plasticized PVC.
• C.S.G.I. Research Organization (Consortium for the Development of Large Interphase Systems)coreStrategic or Co-development PartnerResearch consortium partner in the R&D project for new polymer blends for medical bags. The C.S.G.I. (Inter-university Consortium for the Development of Large Interphase Systems) provided research support through its Siena Operational Unit for the development of eco-sustainable packaging materials.

Scale indicators3 records

Recent moves7 records

Expansion highlights3 records

Broad incumbents

• Recipharm: European-headquartered pharmaceutical CDMO serving pharma clients across multiple dosage forms. Comparable as a regional specialty CMO competitor for pharma manufacturing contracts, though not active in dialysis concentrates specifically.
• Diaverum: One of the world's largest independent renal care service providers operating dialysis clinics across Europe, Latin America, and MEA. As a likely customer of Farmasol, its in-house procurement dynamics and outsourcing strategy are relevant proxies for understanding the customer side of Farmasol's market.
• Fareva: Privately held European pharmaceutical and cosmetic CMO with multiple GMP-certified plants. Useful comparator for understanding European specialty CMO economics, regulatory positioning, and contract negotiation dynamics with global pharma clients.

Direct peers

• Terumo Corporation: Global medical device manufacturer with a significant renal / blood component portfolio including dialysis system accessories. Comparable in product overlap and in selling into multinational dialysis therapy providers that may also be Farmasol customers.
• Fresenius Medical Care: The world's largest provider of dialysis products and services, manufacturing haemodialysis concentrate solutions and operating vertically integrated clinics. Farmasol serves as a contract manufacturer to 'main players' in haemodialysis, of which Fresenius is the largest, making it the most directly comparable reference point for scale, formulation breadth, and customer relationships.
• Baxter International (Vantive Kidney Care): Global medical products company with a dedicated kidney care franchise (now Vantive) that includes haemodialysis solutions and PD fluids. Competes with Farmasol as a vertically integrated concentrate supplier and as a customer sourcing contract manufacturing capacity.
• B. Braun Avitum: Division of B. Braun manufacturing haemodialysis concentrates, dialyzers, and related devices for in-clinic and home use. Comparable to Farmasol in product category (acid and acetate-free concentrates), regulatory positioning (CE/MDR), and B2B pharma supply model.
• Asahi Kasei Medical: Manufactures dialyzers and dialysis-related consumables with growing European presence via Asahi Kasei Biplan. Relevant peer due to its broad renal product portfolio supplying dialysis chains that are likely Farmasol customers or counterparties.
• Rockwell Medical: U.S.-listed pure-play haemodialysis concentrate and dialysate manufacturer (acquired by DGH in 2024). Closest pure-play small-cap comparable to Farmasol in terms of single-category focus on haemodialysis concentrates and contract supply to clinic operators.
• Nipro Corporation: Japanese-headquartered manufacturer of dialyzers, blood lines, and haemodialysis concentrate solutions with European manufacturing footprint. Comparable in multi-formulation concentrate offerings and CMO-style B2B supply to dialysis therapy providers.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/farmasol-srl

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 Farmasol