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Leading CDMO Companies in Poland

Your Trusted Polish Partners for Contract Manufacturing and Development

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BIOLOGICS manufacturing site

MAI network supplier

Mabion is a European biologics development and manufacturing partner focused on biosimilar, large molecule manufacturing, and innovation programs.

Location available after registration

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OLIGONUCLEOTIDES manufacturing site

MAI network supplier

Polpharma API is a European CDMO offering small-molecule, oligonucleotide, and payload-linker for ADC development and manufacturing

Location available after registration

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BIOLOGICS manufacturing site

MAI network supplier

mRNA & LNP manufacturing and Fill and Finish.

Location available after registration

Suggested Results

These facilities match your main criteria but not every optional filter — including other countries in the same region.

HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes
Spain

HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes

HISTOCELL

Histocell is a Spanish CDMO that develops and manufactures cell therapies, secretomes and exosomes, as well medical devices.

SERVICES: Development services, Analytical / QC services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), CDSCO (India), TGA (Australia)

COMPLIANCE: ISO, EMA (EU GMP)

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: COSMETICS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

USE: Human, Veterinary

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

BATCH SIZE: Small, Medium

REGION: Europe

CARBOGEN AMCIS | Vionnaz
Switzerland

CARBOGEN AMCIS | Vionnaz

CARBOGEN AMCIS

Highly Potent APIs development and small-scale cGMP production including chromatography and lyophilization.

SERVICES: Development services, Analytical / QC services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

USE: Human, Veterinary

BATCH SIZE: Small

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

REGION: Europe

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC

FAES FARMA | DERIO facility
Spain

FAES FARMA | DERIO facility

FAES FARMA

Developer and manufacturer of human medicinal products.

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), EDE (UAE), TGA (Australia)

COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human

BATCH SIZE: Large, Small, Medium

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

REGION: Europe

Laboratorios Grifols | Murcia Plant
Spain

Laboratorios Grifols | Murcia Plant

Grifols International

Sterile manufacturing solutions (small molecules) in flexible bags.

MARKETS: EMA (EU), FDA (USA), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

SERVICES: Logistics, Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

REGION: Europe

Cenexi
France

Cenexi

Cenexi

GMP plant on a four-hectare site is located 9 km east of Paris. It is a center of excellence for injectable ampoules.

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), EDE (UAE), TGA (Australia)

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Low potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

REGION: Europe

Nexora Cell and Tissue Therapy Manufacturing Site
Germany

Nexora Cell and Tissue Therapy Manufacturing Site

Green Phoenix Labs GmbH

Licensed ATMP site in Germany. GMP manufacturing and QP batch release for cell and tissue therapies.

SERVICES: Development services, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU)

BSL (Biological Safety Level): 1, 2

USE: Human

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (S) Sensory organs, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism

BATCH SIZE: Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

COMPLIANCE: EMA (EU GMP)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

REGION: Europe

CARBOGEN AMCIS | Bubendorf
Switzerland

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC).

SERVICES: Development services, Analytical / QC services, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

USE: Human, Veterinary

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V09-10) Radiopharmaceuticals, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism

BATCH SIZE: Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: PARTICLE ENGINEERING, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC

REGION: Europe

HIPRA BIOTECH SERVICES | Amer
Spain

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

End-to-end internal capabilities from cell line development to commercial manufacturing.

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)

COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

BSL (Biological Safety Level): 1, 2

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS

REGION: Europe

JAFRAL
Slovenia

JAFRAL

JAFRAL

Integrated biotechnology facility providing R&D, non-GMP and GMP manufacturing, QC testing, and fill & finish services for advanced biologics.

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

COMPLIANCE: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP), SQF (Safe Quality Food)

MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

CONTROLLED SUBSTANCES: Lowest potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (D) Dermatologicals, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism

REGION: Europe

Poland is becoming one of Europe’s fastest-growing hubs for pharmaceutical innovation and contract manufacturing. Partnering with CDMOs in Poland gives pharmaceutical companies and biotech firms access to high-quality drug development, contract manufacturing, and biologics production, supported by experienced teams and compliant facilities.

Whether you’re looking for contract manufacturing in Poland, drug development services, or scalable commercial production, Polish CDMOs offer competitive costs, regulatory compliance, and advanced technological capabilities that help bring products to market efficiently.

Why Choose CDMO Companies in Poland?

Poland provides a combination of European quality standards, skilled workforce, and cost-effective operations. Here’s why pharmaceutical companies choose Polish CDMOs for contract manufacturing and development:

Ensuring compliance through Regulatory Compliance: CDMOs in Poland follow EMA and FDA standards, ensuring GMP-compliant drug development and manufacturing.

Advancing therapies with Advanced Drug Development: From pre-formulation to process optimization, Polish CDMOs offer specialized expertise in small molecules, biologics, and high-potency drugs.

Connecting global markets via a Strategic European Location: Centrally located, contract manufacturers in Poland provide efficient distribution across EU and global markets.

Leveraging technical expertise from a Highly Skilled Workforce: Poland has a strong pool of chemists, engineers, and technical experts supporting development and production projects.

Maximizing value through Cost-Effective Manufacturing: Competitive operational costs make Polish CDMOs attractive for startups, mid-size companies, and global pharmaceutical brands.

Pioneering solutions with Innovation & Technology: Modern facilities, digital integration, and advanced biologics and sterile manufacturing capabilities.

Key Services Offered by Polish CDMOs

Most of theCDMOs in Poland provide end-to-end services for pharmaceutical development and manufacturing, including:

Optimizing formulations during Drug Development & Formulation: Pre-formulation, analytical development, process optimization, and formulation design.

Supplying clinical trials with Clinical Manufacturing: Small-batch GMP production for Phase I-III clinical trials.

Scaling production via Commercial Manufacturing: Full-scale production, packaging, labeling, and logistics for European and global markets.

Maintaining safety in Sterile & Aseptic Manufacturing: Injectable, ophthalmic, and other sterile dosage forms.

Advancing biotherapeutics with Biologics & Biosimilars: Cell line development, upstream/downstream processing, and fill-finish services.

Handling complex compounds in High Potency & Controlled Substances: Specialized containment and safety infrastructure.

Assuring compliance with Regulatory & Quality Support: EMA/FDA filings, audits, and compliance assistance.

Delivering niche solutions through Specialized Services: Orphan drugs, high-barrier generics, advanced delivery systems, and nanoparticle formulations.

Choosing Polish CDMOs ensures access to highly experienced teams capable of handling complex projects while maintaining quality and regulatory standards.

Benefits of Partnering with CDMOs in Poland

Partnering with a Polish CDMO offers multiple advantages for pharmaceutical and biotech companies:

Delivering high standards with High-Quality Standards: Full GMP compliance ensures safe and effective production.

Optimizing investments with Cost-Effective Operations: Lower operational costs without compromising quality.

Accelerating timelines for Fast Time-to-Market: Efficient project management and regulatory expertise accelerate development timelines.

Building success through Trusted Partnerships: Polish CDMOs prioritize transparency, accountability, and long-term collaboration.

Driving efficiency with Technological Capabilities: Cutting-edge facilities for sterile, biologics, and high-potency manufacturing.

Expanding reach via Global Compliance: Seamless adherence to international regulatory standards, simplifying market entry.

Top CDMO Companies in Poland

Leading CDMOs in Poland include:

Syvento: Specializes in mRNA and LNP manufacturing as well as fill-and-finish (F&F) services for pharmaceutical and biotech products. [See CDMO profile]

Mabion: A leading CDMO in Poland offering end-to-end development and GMP manufacturing of biotherapeutics, including monoclonal antibodies and recombinant protein products. [See CDMO profile]

Related Information

Leading CDMO Companies in Europe

Leading CDMO Companies in Belgium

Leading CDMO Companies in France

Leading CDMO Companies in Germany

Leading CDMO Companies in Ireland

Leading CDMO Companies in Italy

Leading CDMO Companies in Netherlands

Leading CDMO Companies in Portugal

Leading CDMO Companies in Spain

Leading CDMO Companies in Switzerland

Leading CDMO Companies in the UK

Let MAI CDMO Network Help You Find the Right Polish Partner

At MAI CDMO, we connect pharmaceutical and biotech companies with the most suitable CDMOs in Poland. Whether you need support with drug development, contract manufacturing, biologics production, or sterile manufacturing, we streamline the process of finding, qualifying, and engaging with the right Polish CDMO to meet your project goals.

Ready to explore your options? Contact us today and let’s help you find a Polish partner that meets your timeline, quality standards, and growth objectives.