• The European API producer since 1951

    We deliver quality

  • Worldwide presence

    World Class Service

  • Intelligent solutions

    Not just API


The European API


API Polpharma is an European producer of Active Pharmaceutical Ingredients delivering products to pharmaceutical companies worldwide. We are present in 6 continents, in 60+ countries, and our market share is constantly growing. Our well-balanced and expanding portfolio, along with our scientific know-how and experience, allow us to offer attractive solutions for drug developers.

We provide a one-stop shop solution of vertically integrated services from API development to FDF formulation and manufacturing, scale-up capabilities based on in-house or external custom developed technologies, to regulatory support. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (ASMF in eCTD format), PMDA (J-DMF) and FDA (US DMF). Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities: USFDA, EMA, EDQM, SKFDA, PMDA, ANVISA, Polish Main Pharmaceutical Inspectorate. Regular FDA audits enabled us to register and sell a number of APIs in the US market and confirm our reliability and credibility towards our business partners around the world.

Our manufacturing site is located in the heart of Europe nearby Gdańsk international airport and major Polish seaports in Gdańsk and Gdynia. With superior quality of products, customer-centric approach and competitive production costs, API Polpharma is a trustworthy global partner.

Our values

  • Focus and commitment in finding innovative solutions for the use of our APIs in breakthrough finished dosage forms for the generic pharma industry
  • Diverse and broad based product portfolio and pipeline, along with innovative non infringing solutions applied in the process development stages, at minimum risk exposure for all of our customers
  • Focus on our customer’s best interest
  • Competitive prices for our products and services that are of superior quality and meet unparallel customer service requirements
  • Sustainable development, product stewardship and efficient supply chain
  • Science and expertise to deliver attractive solutions for drug development
  • Wide reaction classes in FDA approved facilities
  • State-of-the-art technology and best design processes and practices
  • Low cost, highly skilled staff
  • Own R&D resources including pilot plant and wide cooperation with external research and academic institutions and laboratories

What makes us different from other competitors?

  • Full scale and vertical integration of processes from R&D, GMP Pilot plant, scale up to manufacturing.
  • Highly skilled staff with an ever increasing proportion of university graduates.
  • Low cost environment thanks to the competitive labour cost and location of the entire manufacturing site in an economic zone.
  • We have gained the trust of our customers worldwide in terms of quality of our products and services.

Worldwide presence

Our well-balanced and expanding portfolio along with our scientific know-how and experience allow us to offer attractive solutions for drug developers.

Worldwide presence od Polpharma API


  • 1935  Polpharma’s foundation – manufacturing on Bayer technology
  • 1939 – 1945  Taken over by Bayer
  • 1949 Reconstruction of Polpharma after The Second World War. First product after the war - redistilled water in glass ampoules.
  • 1951 Minister of Industry established Starogard Pharmaceutical Plant, which started producing salicylates and sulfonamides.
  • 1959 Starogard Pharmaceutical Plant became a part of the Union of Pharmaceutical Industry “Polfa” and was renamed to Starogard Pharmaceutical Works “Polfa”.
  • 1995 Polpharma transformed into a Joint Stock Company with 100% shares belonging to the State Treasury and returned to its old name - Pharmaceutical Works POLPHARMA S.A.
  • 2000 Spectra Holding and Prokom Investments (Polish capital) bought the majority of the Company shares converting it to a private company.
  • 2007 Strategic alliance with Akrikhin, major generic pharma player in the Russian market.
  • 2010 Acquisition of antibiotic business of Bioton Poland together with a cephalosporin manufacturing plant in Duchnice, Poland.
  • 2011 Polpharma becomes a major shareholder of Akrikhin, Russia
  • 2011 Polpharma becomes a key partner of Chimpharm, Kazakhstan
  • 2012 Polpharma becomes a major shareholder of Polfa Warsaw, Poland


Location – Starogard Gdański, Poland

50 km from Gdańsk international airport
70 km from a major Polish seaport in Gdańsk and Gdynia
11 km from a major highway

Site Data

Industrial area: 104 hectares

  • Finished Dosage Forms Manufacturing
  • API Manufacturing
  • Quality Control Labs
  • R&D Centers for FDF and API
  • Distribution and warehouses
  • Administration offices
  • Infrastructure




Polpharma provides a one-stop shopping solution of integrated services ranging from API development to finished dosage formulation and scale-up capabilities based on in-house or customer developed technology and the support of the registration file.

Professional and experienced team of key account managers guarantee customized service package for each client. We are here to advise in project evaluation, educate our clients about our technology and recommend the appropriate solutions. We provide assistance on every step of the purchasing process.

We offer:

  • Full support from molecule development to drug delivery
  • Development and production of generic APIs
  • Custom synthesis and toll manufacturing
  • Intellectual Property expertise
  • Regulatory compliance
  • Non-infringing process development
  • Development of new salts and polymorphic forms of APIs
  • Wide reaction classes in FDA approved facilities
  • Multipurpose production lines
  • High GMP standards
  • High quality products
  • Excellent service

Cost-effective solutions tailored to the customers needs

We constantly seek ways to add value to everything that we do for our customers. We make efforts to keep our API portfolio updated and expand it with new, attractive compounds.

Our cGMP capacity combined with a short development time and competitive pricing make us a natural choice for pharmaceutical companies interested in outsourcing their manufacturing activities. We have gained an exceptional reputation among our customers worldwide for the quality of our contract manufacturing services.

Core competencies & services

Process upscaling flexibility

  • 5 multipurpose production lines,
  • GMP Pilot plant , temperature range -40° to 120° C,
  • well equipped R&D for innovative chemistry,
  • process development,
  • optimization to up scaling simulation,
  • DoE, Chemometrics, QbD, PAT.

Hazardous chemistry

  • Grignard Chemistry, Hydrogenation,
  • Strong base handling – Sodium metal, hydride;
  • Reaction with sodium amide, Reactions with Lewis,
  • Acid, Reactions with liquid and/or gas ammonia,
  • and Chlorine, Bromination, Bisphosphonation,
  • Friedel Crafts Alkylation.

Solid state chemistry

  • Particle size modulation and optimization,
  • Polymorph study and crystallization , new salts,
  • Co-crystals and adducts.

Network of Alliances

  • Impurity synthesis,
  • Chiral purification,
  • Continuous process,
  • Biocatalysis,
  • Supercritical fluid chemistry and analysis,
  • Peptide chemistry,
  • Polymerisation chemistry,
  • Supply chain management.

Environment-friendly operations

  • RTO – Regenerative thermal oxidizer, recycling to balance PMI, hazardous material management, green chemistry initiatives


We are providing full support from the beginning of cooperation up to the marketing authorisation. Registration documentation for API (ASMF, CEP, US DMF, Japanese DMF) is prepared in eCTD format using the DocuBridge software. Documentation is prepared in accordance with the highest quality standards. Our customers assessed the quality of our documentation as the best in the world. Our registration documentation for APIs is submitted and evaluated by authorities from Europe, USA, Canada, Australia, Japan, Korea, Indonesia, New Zealand, Singapore, Brazil, Israel, Mexico, Malaysia, Sudan, Vietnam, Philippines, China and many others. Head of API Regulatory Team is a Polish Expert in one of API Working Group of EDQM. API Regulatory Team works in close cooperation with the most important authorities like: EMA and EDQM (Europe), FDA and USP (USA) and TPD (Canada).

New requirements and guidelines appear every year. It is due to the fact that higher quality of manufacturing processes and finished APIs is constantly required. To be one of the best on the market, we do not only follow the requirements and guidelines, but we are trying to be ahead of them.


  • USFDA compliant, EDQM, SKFDA, PMD, ANVISA compliant, Polish GIF compliant
  • ISO 14001, OHSAS 18001, PN-N 18001
  • Regulatory documentation (DMF/CEP) recent and restrictive requirement from authorities


Quality, optimization and customer satisfaction
are the driving forces behind our work

Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF).

Material and product testing is performed according to the European and United States Pharmacopeias. However, our products can be additionally tested in compliance with the customer’s specifications.

Production facilities

Polpharma utilizes up-to-date technologies, which ensure the safety of products, employees, and the natural environment.

We have the capabilities...

We have the capabilities to provide customers with materials ranging from clinical quantities up to in-market supply. We have in place full and vertical integration of processes from R&D, pilot plant, scale-up to the manufacturing leverage of our competences in order to deliver cost-effective and in time solutions to our partners. API manufacturing is carried out in cGMP-compliant and FDA-approved multipurpose plants.

Comprehensive list of basic processes

  • Amidation
  • Alcylation
  • Acetylation
  • Bromination
  • Bisphosphonation
  • Chlorination
  • Chlorosulphonation
  • Cyclization
  • Coupling
  • Carboxylation
  • Dehydrogenation
  • Esterification
  • Friedl-Craft’s alcylation
  • Grignard’s reaction
  • Hydrogenation
  • Methylation
  • Metho-/Ethoxylation
  • Oxidation/Reduction
  • Phosgenation (with triphosgene)
  • Saponification
  • Strong base reactions

Available Capacity

  Dedicated Multipurpose
Glass lined 90,000 L 40 reactors 342,000 L 165 reactors
Stainless steel - 25,000 L 15 reactors
Auxiliary tanks - 150,000 L
Tank Farm 900 m3 -

Equipment type

  • Reactors
  • Columns
  • Crystallizers
  • Centrifuges
  • Dryers
  • Filter-dryers
  • Mills
  • Micronizers

Operating ranges

  • Temp. –20°C to +200°C
  • Pressure –1 to +10 bars
  • pH in the full range

Operating ranges Pilot Plant

  • Temp. –80°C to +200°C
  • Pressure –1 to +10 bars
  • pH in the full range

Out-licensing offer

Our services include EU standard dossiers for finished dosage formulations based on APIs developed in-house or outsourced. Our out-licensing portfolio secures the most comprehensive offer for our clients.

What can we offer to our partners?

  • High level of customer service
  • Excellent products with CTD dossier meeting EU requirements
  • Regulatory knowledge and expertise
  • Full support in developing registration strategies to meet the customer’s needs
  • Execution and support of registration procedures upon customer’s request
  • QA service and Pharmacovigilance service (PSUR)
  • Intellectual property expertise
  • Professional and competent team skilled in project management techniques
  • Partnership in a win-win strategy

What makes us different from licensing competitors?

  • Vertically integrated products
  • Relatively low cost production
  • Comprehensive offer and business service
Contact us: salesb2b@polpharma.com



Expansion of our business is primarily driven by innovation.  Our business model is to bring breakthrough innovation in generic API development and incremental improvement in the manufacturing process of the existing products.

Innovation & Intellectual Property

API Polpharma is a holder of several process patents and the rate is targeted to minimum 10 applications per year

Time to market and first to file business orriented objective has intensified creative work at all levels of API development

We respect the legal principles governing intellectual property

We provide financial incentives for the creation of our inventions

We actively pursue the protection of our intellectual property rights however we respect the freedom of culture movement and freedom of knowledge

Patent Approach

Respect for all third party intellectual property rights. Our own patent team is dedicated to designing and defending our processes.

We are experienced in designing new synthesis routes for producing APIs; our patent portfolio proves it.

Innovation - expertise & experience

Our prime assets are the knowledge and extensive expertise of our people.

We employ highly qualified specialists and constantly invest in their continuous education in areas such as:

  • Route of Synthesis Design
  • Patent Environment
  • Regulatory Affairs / Legislation
  • Advanced Intermediates Sourcing and Outsourcing
  • Industrial Engineering
  • Process Modeling
  • Chemoinformatics
  • Quality by Design

A key to the success is a combination of in-house expertise and effective co-operation with scientific institutions.

Our company enjoys the benefit of the experience of specialized external laboratories and institutions both Polish and international, the majority of which are located in Germany, Italy, Sweden, Switzerland, The Netherlands, China and India. The external cooperation is carried out in the following areas:  innovative processes and process techniques development, analytical method development and validation,  as well as Kilo-lab and pilot-plant up-scaling.

To implement wide regulations into our processes, we developed the following practices:

  • Pipeline Committee
  • Project Management
  • Resources planning program


Only Positive
Audit Results

Facilities for the production of APIs undergo rigorous inspections of the U.S. Food and Drug Administration (FDA). Our multipurpose plants passed FDA inspections with no observations on the Form 483 in 2004, 2009, 2012 and, most recently, in January 2015. This is a reason to be proud and confirms the highest quality standards of Polpharma.

We supply APIs for the pharmaceutical companies worldwide. With a competitive cost of production, superior product quality and environmentally friendly processes API Polpharma became the significant European manufacturer.

Our team of highly educated experts assures that the quality of our products is maintained at all stages of the production process. Strict compliance with cGMP procedures, well documented SOPs, and a modern quality control laboratory ensure the APIs produced by POLPHARMA are of the highest quality.

Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities (USFDA, EMA, EDQM, SKFDA, PMDA, ANVISA, Polish Main Pharmaceutical Inspectorate). DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (ASMF in eCTD format), PMDA (J-DMF) and FDA (US DMF).

As part of our commitment to provide the highest quality products, we put the greatest emphasis on:

  • Compliance with cGMP
  • Validation and qualifications of equipment and production processes
  • On-the-job GMP training
  • System procedures
  • Specifications for every stage of production
  • Documentation in CTD format and CEP certificates
  • Qualification and suppliers’ audits
  • Quick response to complaints


  • Polish Main Pharmaceutical Inspectorate GMP API Inspections: 2006, 2007, 2009, 2010, 2011, 2012, 2013, 2014, 2015
  • PIC/S GMP Certificates (Pharmaceutical Inspection Convention Scheme): all synthesis departments – August 2003
  • FDA inspections: 2004, 2009, 2012, 2015 – with no observations on the Form 483
  • Korean FDA inspection: 2010, 2012
  • Over 150 Customer’ audits during years 2008-2014



Seize growth

Research and Development

Development and commercialization of new, attractive APIs is the priority of POLPHARMA’s API R&D Department. The key to our success is the combination of experience and expertise of our own research team as well as effective co-operation with scientific institutions.

50 highly qualified professionals, including 13 with doctoral degrees, are employed in API R&D Department. The R&D function is composed of process development, analytical development and process maintenance and continuous improvement laboratories, and regulatory department. The cGMP pilot plant is equipped with 3 lines with reactor capacity from 50 L up to 630 L.

Seize growth opportunities

  • Our strategy is based on partnerships, which form or strengthen technology platforms for long-term growth, creating value for our customers.
  • Partnerships with other companies and development houses offering new technologies, identify the best projects and drive costs down with environmental sustainability.
  • Novel crystalline salt forms and polymorphs of a drug candidate at an early stage, to drive competitiveness.

Competitive Competences

  • Well-educated and experienced research staff – Process and Analytical
  • Wide network of Research and Development cooperating institutions (Universities, Institutes, CROs, Private Development Labs)
  • Application of Quality by Design and Chemometrics in all steps of process development
  • Project Management and Resources Planning System
  • Wide spectrum of processes and technologies in house and at Partners
  • cGMP Pilot-Plant
  • Experience in scale-up transfers and process improvements
  • Proved Quality of DMF documentation

Spectrum of Chemistry Process Capabilities

(in-house and at partners)

  • Regular Organic Chemistry processes (coupling, condensation, oxidation, reduction, solvolysis etc.)
  • Chiral separation (diastereoisomeric crystallisation)
  • Stereoselective Synthesis
  • Regioselective Synthesis
  • Grignard reactions in large scale
  • Carbohydrate Chemistry (glycosylation, functional groups transformation)
  • Aminoacids and Peptide Chemistry (solution and solid-phase synthesis)
  • Phosphorous Chemistry (eg. Bisphosphonates)
  • Polymorphism and solid state chemistry
  • Catalysis (phase transfer catalysis, heterogenous and homogenous)
  • Catalytic Hydrogenation at large scale
  • Sodium amide at large scale



CAS No.: 152-72-7

Acetazolamide [inj.]
Acetazolamide [inj.]

Polymorph form: Form II
CAS No.: 59-66-5
US DMF No.: 10383
Other Information: Trihydrate

Alendronate sodium
Alendronate sodium

Polymorph form: Trihydrate
CAS No.: 121268-17-5
US DMF No.: 16962
Other Documentation: Japanese DMF
Other Information: Trihydrate


Polymorph form: Monoclinic form
CAS No.: 72432-10-1

Aripiprazole [inj.]
Aripiprazole [inj.]

Polymorph form: Type I
CAS No.: 129722-12-9
US DMF No.: 23314


Polymorph form: Crystalline, none
CAS No.: 330784-47-9
US DMF No.: Q4 2015
Other Information: Crystalline

Baclofen [inj.]
Baclofen [inj.]

Polymorph form: Form B
CAS No.: 1134-47-0
US DMF No.: 18014
Other Documentation: Japanese DMF

Bazedoxifene acetate
Bazedoxifene acetate

Polymorph form: Form A
CAS No.: 198481-33-3
EU DMF: Q2 2016
US DMF No.: Q2 2016


Polymorph form: Form III
CAS No.: 298-46-4
US DMF No.: 26266


Polymorph form: Form II
CAS No.: 72956-09-3
US DMF No.: 17060

Carvedilol phosphate hemihydrate
Carvedilol phosphate hemihydrate

Polymorph form: Form I
CAS No.: 610309-89-2
US DMF No.: 20633


CAS No.: 636-54-4

Cyclobenzaprine hydrochloride
Cyclobenzaprine hydrochloride

Polymorph form: Crystalline, none
CAS No.: 6202-23-9
US DMF No.: 18317


Polymorph form: Crystalline racemate, none
CAS No.: 41340-25-4
US DMF No.: 11405
Other Documentation: Japanese DMF
Other Information: Crystalline


Polymorph form: Form I
CAS No.: 58-93-5
US DMF No.: 17599
Other Documentation: Japanese DMF

Ibandronate sodium [inj.]
Ibandronate sodium [inj.]

Polymorph form: Monohydrate
CAS No.: 138926-19-9
US DMF No.: 25638
Other Information: Monohydrate


Polymorph form: Anhydrous monoclinic
CAS No.: 84057-84-1
US DMF No.: 20548
Other Documentation: Chinese DMF - under reg.

Magnesium aspartate
Magnesium aspartate

Polymorph form: Amorphous
CAS No.: 28184-71-6

Metronidazole [inj.]
Metronidazole [inj.]

Polymorph form: Monoclinic crystal system with space group P21/c
CAS No.: 443-48-1
US DMF No.: 9294

Nefopam HCl*
Nefopam HCl*

CAS No.: 23327-57-3

Opipramol dihydrochloride
Opipramol dihydrochloride

Polymorph form: Amorphous
CAS No.: 909-39-7
Other Information: Amorphous

Pentoxifylline [inj.]
Pentoxifylline [inj.]

Polymorph form: Form I
CAS No.: 1677687
US DMF No.: 20976

Phenyl salicylate
Phenyl salicylate

Polymorph form: Crystalline orthorhombic form
CAS No.: 118-55-8

Piracetam [inj.]
Piracetam [inj.]

Polymorph form: Form II
CAS No.: 7491-74-9

Prasugrel hydrochloride
Prasugrel hydrochloride

Polymorph form: Form B2
CAS No.: 389574-19-0
EU DMF: Q1 2016
US DMF No.: Q1 2016
Other Documentation: Technical File

Prasugrel maleate
Prasugrel maleate

Polymorph form: Form 1
EU DMF: Q1 2016
US DMF No.: Q1 2016
Other Documentation: Technical File

Rasagiline tartrate [inj.]
Rasagiline tartrate [inj.]

Polymorph form: Form I
CAS No.: 136236-52-7


Polymorph form: Form I
CAS No.: 135062-02-1
US DMF No.: 21149

Risedronate sodium
Risedronate sodium

Polymorph form: Form A
CAS No.: 329003-65-8
US DMF No.: 20384
Other Documentation: Japanese DMF


Polymorph form: Monoclinic form (space group I2/a)
CAS No.: 65-45-2

Sildenafil base
Sildenafil base

US DMF No.: 28319

Sildenafil citrate
Sildenafil citrate

Polymorph form: Anhydrous Form
CAS No.: 171599-83-0
US DMF No.: 23930
Other Documentation: Japanese DMF / Chinese D
Other Information: Anhydrous

Sodium salicylate
Sodium salicylate

Polymorph form: Monoclinic form (space group P21/m)
CAS No.: 54-21-7
US DMF No.: 26873

Tolterodine tartrate
Tolterodine tartrate

Polymorph form: Form I
CAS No.: 124937-52-6
US DMF No.: 24345


Polymorph form: Orthorhombic structure
CAS No.: 97240-79-4
US DMF No.: 20581

Xylometazoline HCl
Xylometazoline HCl

CAS No.: 1218-35-5

Zoledronic acid [inj.]
Zoledronic acid [inj.]

Polymorph form: Monohydrate
CAS No.: 165800-06-6
US DMF No.: 24306
Other Documentation: Japanese DMF
Other Information: Monohydrate

[inj.] optional injectable form available   |   * Polfa Warsaw API Manufacturing Site

AP ASMF (Applicant’s Part): 111   |   RP ASMF (Restricted Part): 96   |   US DMF: 28 / JAPANESE DMF: 7   |   CEP: 17


Products protected by valid patents are not offered for 'commercial' sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer's responsibility and liability to check the patent situation of the product in the imported market(s).

API Polpharma Pipeline

Advanced Stage

 ProductTherapeutic Area
1 Apixaban Cardiovascular
2 Apremilast Psoriasis, psoriatic arthritis,
ankylosing spondylitis
3 Dabigatran etexilate mesylate Cardiovascular / Anticoagulant
4 Dapagliflozin Diabetes Treatment / Type II Diabetes
5 Linagliptin Diabetes Treatment / Type II Diabetes
6 Rivaroxaban Cardiovascular / Anticoagulant
7 Saxagliptin hydrochloride Diabetes Treatment / Type II Diabetes
8 Saxagliptin monohydrate base Diabetes Treatment
- Type II Diabetes
9 Sofosbuvir Antiviral
- treatment of hepatitis C
10 Tadalafil Men's health
Erectile Dysfunction
11 Ticagrelor Anticoagulant
12 Vardenafil hydrochloride Men's health / Erectile Dysfunction

* product not covered by a compound patent in the territory of Poland

Early Development

14SafinamideParkinson’s disease, dual-mechanism: MOA-B and glutamate release inhibitor

 ProductTherapeutic Area
1 Asunaprevir Antiviral - treatment of hepatitis C
2 Brexpiprazole MDD, schizophrenia, ADHD
3 Cangrelor Antiplatelet
4 Dabrafenib Oncology; antineoplastic
5 Daclatasvir Antiviral - treatment of hepatitis C
6 Edoxaban Tosylate Venous thromboembolism and stroke treatment
7 Empagliflozin Diabetes Treatment / Type II Diabetes
8 Icatibant* Hereditary Angioedema (HAE)
9 Ledipasvir Antiviral - treatment of hepatitis C
10 Linaclotide* Irritable Bowel Syndrome (IBS)
11 Lixisenatide Diabetes Treatment / Type II Diabetes
12 Odanacatib Osteoporosis, bone metastasis
13 Riociguat Pulmonary hypertention
14 Safinamide Parkinson's disease, dual-mechanism: MAO-B and glutamate release inhibitor
15 Suvorexant Insomnia
16 Teriflunomide Multiple Sclerosis
17 Tofacitinib citrate Rheumatoid arthritis, psoriasis, inflammatory bowel disease
18 Vortioxetine Major depressive disorder

* product not covered by a compound patent in the territory of Poland


The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.