We make finished medicines in every major form, by the billion.

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Polpharma Group turns its own active substances and formulations into the finished medicine, on five specialised plants producing at the scale a region's supply depends on.

TABLETS A YEAR

5.2B

CAPSULES A YEAR

700M

AMPOULES A YEAR

185M

PLANTS ACROSS CEE & CAC

7

SKUS IN SALES

2,000+

REVENUE MADE IN-HOUSE

75%

Forms few European plants can manufacture.

Beyond the standard oral range, the Group operates the specialty platforms most generic manufacturers contract out - certified and at commercial scale.

Blow-Fill-Seal Parenterals

LDPE small- and large-volume parenterals formed, filled and sealed in one aseptic step - 185 million ampoules a year across the network.
BFS · SVP + LVP

Cephalosporin Antibiotics

First-, second- and third-generation cephalosporins, sterile and oral, in a dedicated beta-lactam plant kept fully apart from the rest of the network.
1ST-3RD GEN · STERILE + ORAL · SEGREGATED BETA-LACTAM

Co-Integrated Inhalers

Dry-powder inhalers where the device and the medicine are registered as one product - first to the EU market with glycopyrronium, in mono and combination forms, with new capacity in construction for volume.
DPI · 1ST TO EU MARKET · MONO + COMBO

Complex Sterile Injectables

Lyophilisates, peptide and oligonucleotide injectables, pre-filled syringes and sterile implantation tablets - the sterile categories that need both the plant and the process.
LYOPHILISATES · PEPTIDES · PFS · IMPLANTATION

High-Potent Solids

Highly active oral solids made under isolator containment in segregated suites, to occupational exposure band 5 - the line the Group's own oncology portfolio is being brought up on.
OEB 5 · ISOLATOR CONTAINMENT

Long-Acting Injectables

Depot injections built on nano-milling and lyophilisation - the technologies that hold a molecule in the body for weeks. A long-acting antipsychotic injectable is already in market, with the platform developed at the Warsaw R&D centre.
LAI · NANO-MILLING · LYOPHILISATION

Preservative-Free Ophthalmics

Multidose eye drops formulated and filled without benzalkonium chloride - nine ECO products developed and a preservative-free anti-glaucoma range already in market.
MULTIDOSE · BAK-FREE

Soft Gelatin Capsules

A billion soft gelatin capsules a year, including gastro-resistant forms - pharma-grade softgel capacity at a scale few European sites run.
1 BILLION A YEAR · GASTRO-RESISTANT

Group’s commentary

The formulation, device and synthesis work behind these programmes runs at the Group's R&D centres.

The Manufacturing Network

An integrated manufacturing platform,
built for reliability of supply.

Starogard Gdański
,
Poland
ZF Polpharma

Solid oral forms & sterile parenterals at scale

A high-volume site for solid oral forms and sterile pharmaceutical liquids. Tablets, hard capsules and sterile subdermal tablets for implantation are produced alongside two sterile technologies: BFS for small- and large-volume parenterals, and glass ampoules. It also manufactures ophthalmic forms and pre-filled syringes.
Nowa Dęba
,
Poland
ZF Polpharma

High-potent & high-containment solid forms

The Group's specialist site for solid oral dosage forms with a focus on high-potent and high-containment capabilities. The site manufactures tablets, coated tablets, hard gelatin capsules, granulates, sachets and dietary supplements, supporting efficient and compliant manufacturing.
Sieradz
,
Poland
ZF Polpharma

Soft-gel capsules, non-sterile liquids & DPI

A site specialising in soft gelatin capsules, including gastro-resistant capsules, semi-solid gels, and non-sterile liquids such as suspensions, syrups, solutions, drops and nasal forms. It also manufactures respiratory dry-powder inhalers, along with topical and cosmetic products.
Duchnice
,
Poland
ZF Polpharma

Cephalosporin antibiotics, sterile & oral

A cephalosporin plant, manufacturing sterile powders for injection and infusion and cephalosporin tablets for the oral range. It focuses on sterile manufacturing, quality and operational reliability.
Shymkent
,
Kazakhstan
Polpharma Santo

Parenterals & sterile antibiotics for Central Asia

The Santo plant, serving Central Asian markets. It manufactures parenteral forms (small- and large-volume), sterile cephalosporin antibiotics, solid dosage forms, sachets and non-sterile liquids. In 2025 the site earned the first EU GMP certificate issued to a pharmaceutical operation in Central Asia.
Poznan
,
Poland
Ziołolek

Pharma & cosmetic forms across all formats

Ziołolek manufactures solid, semi-solid and liquid forms across both pharmaceutical and cosmetic production: medicinal and cosmetic ointments, liquid medicines, tablets and pills, dietary supplements, and liquid, semi-solid and powder cosmetics. It supports OTC, cosmetic and CHC-related product development.
Lublin
,
Poland
Polfa Lublin

Ophthalmic packaging & dosing components

Polfa Lublin specializes in plastic primary packaging and selected medical device components. The site provides end-to-end service: develops packaging solutions supporting safe medicine production and invests in automation, digital monitoring and efficient technologies.

500+ products and 2000+ SKUsacross the therapeutic spectrum.

Our portfolio covers prescription and over-the-counter products for our key therapy areas, as well as medicines and healthcare solutions developed in collaboration with business partners. Our catalogue comprises 500 products, and our plants produce approximately 400 million packs a year.

CHC, self-care & nutrition
Vitamins, supplements & dietary foods
Probiotics (Acidolac), multivitamins, minerals and omega-3 span capsules, sachets, drops and powders, with a leading regional Vitamin D position.
CHC
CHC, self-care & nutrition
Herbal medicinal products
Plant actives - chamomile, melissa, St John's wort, peppermint and hawthorn, plus the Fitolizyna urinary range - span drops, syrups and capsules.
CHC
CHC, self-care & nutrition
Cosmetics
Dermocosmetic creams, gels, shampoos and sachets cover skin and hair care, including the Eloderm emollient line and the Biotebal hair-care range.
CHC
CHC, self-care & nutrition
Consumer Health
OTC self-care brands span vitamin D (Ibuvit D), minerals and everyday remedies, built through 15+ Rx-to-CHC switches, across tablets, capsules and drops.
CHC
CHC, self-care & nutrition
Pediatrics
An age-appropriate paediatric range built on child-friendly forms - syrups, sachets and softgels - including ibuprofen (Ibufen) and vitamin D.
RX
/
CHC
CHC, self-care & nutrition
General Medicine
A broad primary-care range of everyday general medicines and essentials, across solid oral, liquid and topical forms.
RX
/
CHC
Oncology & advanced therapies
Oncology
Pomalidomide anchors an in-licensed and distributed oncology generics range for the hospital channel, with own high-potency solid-oral products being brought up under containment up to OEB 5.
RX
Women's & men's health
Urology
The PDE5 inhibitors sildenafil (Maxigra) and tadalafil and the antimuscarinic solifenacin span solid oral forms.
RX
/
CHC
Women's & men's health
Gynecology
Contraception and HRT cover desogestrel, dienogest, dydrogesterone, estradiol and levonorgestrel, plus an etonogestrel vaginal ring, across oral and intravaginal forms.
RX
/
CHC
Immunology & inflammation
Immunology
Fingolimod and dimethyl fumarate cover multiple sclerosis, with pomalidomide in haematological disease, across solid oral forms.
RX
Immunology & inflammation
Dermatology
Topical antifungals, corticosteroids and antibacterials - amorolfine, ciclopirox, mometasone, fusidic acid and gentamicin - span creams, ointments, gels and solutions.
RX
/
CHC
Immunology & inflammation
Musculoskeletal
Alendronic acid, dexketoprofen, ketoprofen and febuxostat cover osteoporosis and rheumatology, across oral, topical and injectable forms.
RX
/
CHC
Gastrointestinal
Dentistry
Metronidazole, antiseptics, topical corticosteroids and benzydamine cover oral and dental care, across solutions, sprays and tablets.
RX
/
CHC
Gastrointestinal
Gastroenterology
Proton-pump inhibitors omeprazole, esomeprazole and pantoprazole lead the range, with pancreatin, drotaverine and loperamide, across solid oral, sachet and liquid forms.
RX
/
CHC
Respiratory, ophthalmic & ENT
Allergology
Antihistamines bilastine, cetirizine, desloratadine, fexofenadine, ketotifen and olopatadine span tablets, syrups, drops and eye drops, several as Rx-to-CHC switches.
RX
/
CHC
Respiratory, ophthalmic & ENT
Otorhinolaryngology
Decongestants xylometazoline (Xylogel), oxymetazoline and pseudoephedrine, with ciclesonide, span nasal sprays, gels and drops.
RX
/
CHC

Portfolio Information

Detailed portfolio information, product registrations and market-specific availability are provided through approved business channels and in accordance with applicable regulatory and confidentiality requirements.

Contract manufacturing runs as its own B2B operation, with a dedicated team and site network.

Rx, OTC, supplements and cosmetics made across our EU GMP plants, with analytical support, technology transfer, serialisation and QP release handled end to end. A dedicated project manager stays with the product from transfer to routine supply.

cmo.polpharma.com

Learn more

PARTNERSHIP models

The Group's own FDF platform is open to your product.

FDF Manufacturing

The Group's own portfolio made in plants every day under unified Quality System, on lines kept qualified and processes kept proven by continuous commercial production.
Our medicines, our plants.

FDF CMO

Commercial-scale manufacturing of your finished form on qualified lines, packed, serialised and released to the standards of the markets you sell into, with QP release and lifecycle support.
Your dossier, our capacity & expertise.

FDF Co-development

A finished product designed around your active substance - formulation, process and dossier through bioequivalence - then carried to validated commercial supply on the Group's own FDF network, with shared risk available across the project.
Your molecule. Our dose form.

Technology transfer

An existing product moved onto the network and made routine - method transfer, validation, scale-up and supplier qualification - to secure a second source or a larger, multi-market footprint.
Your product, our lines.

FROM TRANSFER TO SUPPLY

A product moves from tech transfer to full-rate supply on lines already in daily production.

A transfer-in or a new build follows the same staged route the Group uses to bring up its own launches - assessed, validated, registered and scaled, each gate signed off before the next opens.

1
ASSESSMENT

Feasibility & transfer

Formulation, analytical methods and equipment fit are assessed against the chosen line; a pilot batch confirms the process before either side commits.

ASSESSMENT

Gap analysis → pilot

2
VALIDATION

Process validation

The process is qualified and locked under GMP across consecutive validation batches, with stability started to ICH conditions.

VALIDATION

Pilot → validation batches

3
REGULATORY

Filing & registration

The manufacturing site is filed and cleared in each target market - a variation to an existing authorisation, or a new one where needed.

REGULATORY

DOSSIER → approval

4
Commercial

Commercial supply

The first commercial batch is released on the launch date, then scaled to full rate with serialisation and ongoing product quality review.

Commercial

Launch → full rate

Previous
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Regulatory & Quality

EU GMP at every plant, with the certification each market requires.

Polpharma operates a single Quality Management System across all manufacturing sites, ensuring consistent standards and continuous improvement throughout the organization.

Track record at a glance

Quality

5

EU GMP-certified

plants

5+

Regulatory inspections

performed annually by authorities

50+

Customer audits

hosted each year

60+

Internal audits

conducted annually on average

Filed and maintained against every framework where the developed portfolio ships.

Regulatory

We have successfully undergone numerous regulatory inspections and audits conducted by health authorities and certification bodies worldwide, including the Eurasian Economic Union (EAEU), the Saudi Food and Drug Authority (SFDA), the Ukrainian authority, and TÜV NORD for Medical Devices.

Health Canada
·
Canada
NMPA
·
China
MFDS
·
South Korea
PMDA
·
Japan
ANVISA · CADIFA
·
Brazil
EAEU GMP
·
EAEU
US FDA
·
United States
URPL
·
Poland
GIF
·
Poland
EDQM · CEP
·
EU
EMA
·
EU

Drug security index

Through the pandemic and the 2022 European energy crisis, supply held without interruption. The Group is the only manufacturer in Poland of 42 medicinal products, several of them life-saving, and holds a drug-security index of 92 percent across the Polish operations.

how we work with you

One operating standard, run by the people you actually talk to.

Working with Polpharma Group means partnering with teams that combine manufacturing expertise, quality-focused execution and a structured approach to operational excellence.

We manage the activities required to bring finished pharmaceutical products to patients, from production and packaging through quality oversight and market-specific requirements, while maintaining consistent standards across the manufacturing network.

Reliable
supply planning

Production schedules are managed through established planning processes designed to support continuity, flexibility and long-term cooperation with our partners.

Market-ready
packaging solutions

Packaging materials and product information are prepared in accordance with applicable regulatory requirements and adapted to the needs of individual markets.

Compliance
and traceability

Products are manufactured, packed and distributed within defined quality systems and in accordance with applicable regulatory and traceability requirements.

Coordinated
lifecycle management

Changes affecting products, materials or processes are managed through structured cross-functional collaboration to help ensure alignment between manufacturing, quality and regulatory requirements.

"To remain competitive in both domestic and international markets, we need to be flexible and maintain precise control over our processes. Harmonised processes across the organisation, reduced time spent on reporting and data administration, and the ability to respond immediately to process deviations all support this.

Dorota Chęć Supply Chain Management Head

WHY US

We build our business around long-term partner supply.

Primarily, Polpharma Group runs manufacturing network to produce own product portfolio to maximize value chain. The same lines, quality system and supply discipline are open to partners bringing a product to manufacture or a process to move in.

20%+
of Group revenue from partnerships

Partner work already brings in more than a fifth of Group revenue, so a partner's programme sits inside the core business, with the attention that carries.

100+
 partners sourcing from the Group

More than a hundred companies worldwide source products from the Group, across FDF supply, technology transfer and long-term manufacturing.

60+
 partnership deals closed a year

Over sixty partnership deals close in a typical year, a cadence that comes from doing this routinely rather than opportunistically.