• The european api producer since 1951

    We deliver quality


    FDA-APPROVED AND cGMP-COMPLIANT PRODUCTION SITE

About us

YOUR LONG-TERM PARTNER OF CHOICE

THROUGH INNOVATION IN API DEVELOPMENT

API Polpharma is a significant European producer of Active Pharmaceutical Ingredients delivering products to pharmaceutical companies worldwide. We are present on 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 VALUES EQUAL
COMMITMENT TO:

  • Offer a broad based product portfolio and pipeline
  • Offer custom-made synthesis and individual approach to non-standard queries and projects
  • Find innovative solutions to use our APIs in breakthrough finished dosage forms
  • Pioneer non infringing solutions applied in the process development stages, at minimum risk exposure for all of our customers
  • Serve our Client’s best interest at all times
  • Offer competitive prices for our superior quality products and services
  • Foster sustainable development, product stewardship and efficient supply chain
  • Build on science and expertise, state-of-the-art technology, best design processes and practices to deliver attractive solutions for drug development

what makes us different from other competitors?

With superior quality of products, customer-centric approach and competitive production costs, API Polpharma is your trustworthy global partner of choice

  • 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
  • Competitive labor costs and manufacturing site located in the economic zone
  • Wide reaction classes in FDA approved facilities
  • State-of-the-art technology and best design processes and practices
  • Own R&D resources including pilot plant and wide cooperation with external research and academic institutions and laboratories

kaizen means change for better

Comprised of highly skilled professionals, our Customer Service Team is committed to helping your business grow in the dynamic pharma environment. We put our customers at the core of what we do. Thus, in our ongoing effort to provide you the highest quality of service, we adopted the Kaizen methodology at the heart of which lies the idea of sustained continual improvement.

Our service establishes and enhances trust being the foundation of long-term business relations.

Worldwide presence

  • We are present in 6 continents
  • We supply to 60+ countries
  • Our key export regions are: Europe, Asia and North America
  • We are a trustworthy partner to 300 customers worldwide



1
North
America
2
Latam
3
Europe
4
Mena
5
Asia
6
Australia

HISTORY

1935
 
1935

Polpharma is founded
– manufacturing on Bayer technology

1939-1945

Bayer takes over

1939-1945
 
1949
 
1949

Reconstruction of Polpharma after II World War. First product after the war - redistilled water in glass ampoules.

1951

Minister of Industry establishes Starogard Pharmaceutical Plant
which starts producing salicylates
and sulfonamides.

1951
 
1959
 
1959

Starogard Pharmaceutical Plant becomes a part of the Union of Pharmaceutical Industry “Polfa” and is renamed to Starogard Pharmaceutical Works “Polfa”.

1995

Polpharma transforms into a Joint Stock Company with 100% shares belonging to the State Treasury and returns to its old name - Pharmaceutical Works POLPHARMA S.A.

1995
 
2000
 
2000

Spectra Holding and Prokom Investments (Polish capital) buy 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.

2007
 
2010
 
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
 
2011
 
2011

Polpharma becomes a key partner of Chimpharm, Kazakhstan

2012

Polpharma becomes a major shareholder of Polfa Warsaw, Poland

2012
 

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




Mapa

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

 

API Polpharma
API POLPHARMA

Services

WORLD CLASS SERVICE

OUR OFFER

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 appropriate solutions. We provide assistance in 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 and guidance
  • Regulatory compliance
  • Development of new salts and polymorphic forms of APIs
  • Adjusted particle size distribution (PSD)
  • Non-infringing process development
  • Wide reaction classes in FDA approved facilities
  • Multipurpose production lines
  • High GMP standards
  • High quality products
  • Excellent service

SOLUTIONS TAILORED TO YOUR NEEDS

In addition to a diverse and broad product portfolio of superior quality, excellent customer service and efficient supply chain, Polpharma B2B offers custom-made synthesis service for clients looking for a European manufacturing site for their active substances.

Polpharma B2B offers full support from process optimization, analytical method development & validation, to process scale-up to pilot plant (kg scale) and fully commercial, multiple tons synthesis in EU cGMP, FDA (US), Anvisa (Brazil), PMDA (Japan) & KFDA (Korea) approved facility.

The scope of our services includes also preparation of comprehensive regulatory documentation in an eCTD format. The entire process is led by professional project management team coordinating for you all project activities performed by the R&D, RA, QA and other Operational departments of Polpharma - all of this with the sole purpose of you maintaining a full control over your product.

WE INVEST WITH YOUR FUTURE IN MIND

We are responsive to the ever-changing dynamics of global markets. Seeing how rapidly the demand for active pharmaceutical ingredients grows, we decided to significantly increase productivity within this area by investing into a complex modernization of API production lines.

The enterprise will allow us to expand manufacturing capacity and thus become more flexible when responding to customers’ needs.

The new facility will be compliant with the highest manufacturing standards. Equipment delivered by globally recognized suppliers will ensure safety of API production in conformity with Polpharma quality standards as well as increasing cGMP requirements.

Our production area has been designed to enable parallel manufacturing of API on two additional production lines – to accommodate for expanding demand of our key products.

Core competencies & services

Process upscaling

  • 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

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 in line with 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 full and vertical integration of processes from R&D, pilot plant, scale-up to the manufacturing leverage of our competences in place so that cost-effective and on-time solutions are delivered to our partners. API manufacturing is carried out in cGMP-compliant and FDA-approved multipurpose plant.

  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

REGULATORY SERVICE

We provide full support from the beginning of cooperation up to the marketing authorization. Registration documentation for API (ASMF, CEP, US DMF, Japanese DMF) is prepared in an eCTD format using the DocuBridge software. Documentation is prepared in accordance with the highest quality standards. It has been submitted and evaluated by authorities from Europe, USA, Japan, Canada, Israel, Australia & New Zealand, Brazil, Mexico, China, India, Egypt, Korea, Singapore, Indonesia, Malaysia, Philippines, Sudan, Vietnam and many others. Head of Polpharma Regulatory Team is an Expert in one of EDQM API Working Groups.

We work in close cooperation with key global health authorities: EMA and EDQM (Europe), FDA and USP (USA) and TPD (Canada) and manufacture our products in agreement with the most rigorous requirements of USFDA, EMA, EDQM, SKFDA, PMDA, ANVISA and Polish Main Pharmaceutical Inspectorate.

New requirements and guidelines appear every year which enforce higher quality of both measuring processes and that of finished API. In order to maintain the position of one of the best on the market, we not only follow requirements but we are ahead of them.

COMPLIANCE WITH REGULATIONS

GLOBAL AUTHORITIES

USFDA compliant, EDQM, SKFDA, PMD, ANVISA compliant, Polish GIF compliant

ISO

ISO 14001, OHSAS 18001, PN-N 18001

REGULATORY DOCUMENTATION

Regulatory documentation (DMF/CEP) recent and restrictive requirement from authorities

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 dossiers meeting EU requirements
  • Regulatory knowledge and expertise
  • Full support in developing registration strategies to meet the customers’ needs
  • Execution and support of registration procedures upon customers’ 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

Innovation

EXPANSION DRIVEN BY INNOVATION

Innovation & Intellectual Property

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 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 oriented objectives have intensified creative work at all levels of API development
   We respect legal principles governing intellectual property
   We provide financial incentives for 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

Respecting all third party intellectual 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 / Legislations
  • 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
  • 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

Quality

Only Positive Audit Results

HIGHEST QUALITY STANDARDS

Facilities for the production of APIs undergo rigorous inspections of the U.S. Food and Drug Administration (FDA). Our multipurpose plant 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 of 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 a 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 that 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 an CTD format and CEP certificates
  • Qualification and audits of suppliers
  • Quick response to complaints

Audits

Over 200 audits performed by our customers during years 2008-2015
2008 - 2012: 127    |    2013: 34    |    2014: 34    |    2015: 34

2003  [ August ] IC/S GMP Certificates (Pharmaceutical Inspection Convention Scheme): all synthesis departments
2004  FDA inspection
2006  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
2007  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
2009  FDA inspection
2010  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
 Korean FDA inspection
2011  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
2012  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
 FDA inspection
 Korean FDA inspection
2013  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
2014  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
2015  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
 FDA inspection (with no observations on the Form 483)

R&D

Products

Seize growth opportunities

  Our Prorities


RESEARCH AND DEVELOPMENT

Development and commercialization of new, attractive APIs is the priority of the POLPHARMA 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. 

57 highly qualified Professionals, including 16 with PhD degrees, are employed in API R&D Department:

 
5 R&D Management
(including Planning)
3 Project
Management
20 Analytical
Development
Laboratory
13 New Process
Development
4 Process
Improvement
Laboratory
12 Regulatory Service
Dept. & Prod. Doc.
 

 


Borderless r&d

R&D development approaches

  • Project development strategy for early launch in FTO and launch in IP regulated territory
  • Identification and differentiation in API in terms of CQA
  • New Therapeutic Categories/Technologies

Acquisition of Technology and Technological Solutions

  • to bridge the gap for Product launch

Strategic partnerships

  • integrated network with external competency centers
  • Our strategy is based on partnerships which form and strengthen technology platforms for long-term growth, creating value for our customers.
  • Partnerships with other companies and development houses offer new technologies, identify the best projects and drive costs down with environmental sustainability.


  ADDED VALUE TO BUSINESS

 

  • First generic launch - Technology development strategy for IP-regulated markets
  • Technology development strategy for early launch in non-IP and non-regulated markets
  • API differentiation – Solutions for new or mature API for line extension as well as generic launch in line with innovator (solid state chemistry, pro-drug, chiral compounds, adducts) in FDF development
  • New therapeutic category/technologies – Peptides and Oncology




  Competitive Competences

 

  • Well-educated and experienced research staff – Process and Analytical
  • Compliance with GLP requirements in line with FDA and ICH guidelines
  • Wide network of Research and Development cooperating institutions (Universities, Institutes, CROs, Private Development Labs)
  • Application of Quality by Design and Chemometrics in process development
  • Project Management and Resources Planning System
  • Wide spectrum of processes and technologies in house and with Partners
  • cGMP Pilot-Plant
  • Experience in lab development, scale-up transfers and process improvements

  Spectrum of Chemistry Process Capabilities (in-house and at partners)

  • Regular Organic Chemistry processes (coupling, condensations, oxidations, reductions, solvolysis etc.)
  • Chiral separations (diastereoisomeric crystalizations)
  • Stereoselective Synthesis
  • Regioselective Synthesis
  • Grignard reactions in large scale
  • Carbohydrate Chemistry (glycosylations, functional groups transformations)
  • 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

Search by product

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Acenocumarol*
Acenocumarol*
EU DMF:
CAS No.
152-72-7
Acetazolamide
Acetazolamide
EU DMF:US DMF No.: 10383CEP:
Polymorph form CAS No.
Form II 59-66-5
Alendronate sodium
Alendronate sodium
EU DMF:US DMF No.: 16962CEP:
Polymorph form CAS No. Other Documentation Other Information
Trihydrate 121268-17-5 Japanese DMF Trihydrate
Aniracetam
Aniracetam
EU DMF:
Polymorph form CAS No.
Monoclinic form 72432-10-1
Aripiprazole
Aripiprazole
EU DMF:US DMF No.: 23314CEP:
Polymorph form CAS No.
Type I 129722-12-9
Avanafil
Avanafil
EU DMF:
Polymorph form
Crystalline, none
Baclofen
Baclofen
EU DMF:US DMF No.: 18014CEP:
Polymorph form CAS No. Other Documentation
Form B 1134-47-0 Japanese DMF
Bazedoxifene acetate
Bazedoxifene acetate
US DMF No.: Q3 20
Polymorph form CAS No.
Form A 198481-33-3
Carbamazepine
Carbamazepine
EU DMF:US DMF No.: 26266CEP:
Polymorph form CAS No.
Form III 298-46-4
Carvedilol
Carvedilol
EU DMF:US DMF No.: 17060CEP:
Polymorph form CAS No.
Form II 72956-09-3
Carvedilol phosphate hemihydrate
Carvedilol phosphate hemihydrate
EU DMF:US DMF No.: 20633
Polymorph form CAS No.
Form I 610309-89-2
Clopamide*
Clopamide*
EU DMF:
CAS No.
636-54-4
Cyclobenzaprine hydrochloride
Cyclobenzaprine hydrochloride
EU DMF:US DMF No.: 18317
Polymorph form CAS No.
Crystalline, none 6202-23-9
Etodolac
Etodolac
EU DMF:US DMF No.: 11405CEP:
Polymorph form CAS No. Other Documentation
Crystalline racemate, none 41340-25-4 Japanese DMF
Hydrochlorothiazide
Hydrochlorothiazide
EU DMF:US DMF No.: 17599CEP:
Polymorph form CAS No. Other Documentation
Form I 58-93-5 Japanese DMF
Ibandronate sodium
Ibandronate sodium
EU DMF:US DMF No.: 25638
Polymorph form CAS No. Other Information
Monohydrate 138926-19-9 Monohydrate
Lamotrigine
Lamotrigine
EU DMF:US DMF No.: 20548CEP:
Polymorph form CAS No. Other Documentation
Anhydrous monoclinic 84057-84-1 Chinese DMF - under reg.
Magnesium aspartate
Magnesium aspartate
EU DMF:
Polymorph form CAS No.
Amorphous 28184-71-6
Metronidazole
Metronidazole
EU DMF:US DMF No.: 9294
Polymorph form CAS No.
Monoclinic crystal system with space group P21/c 443-48-1
Nefopam HCl*
Nefopam HCl*
EU DMF:
CAS No.
23327-57-3
Opipramol dihydrochloride
Opipramol dihydrochloride
EU DMF:
Polymorph form CAS No. Other Information
Amorphous 909-39-7 Amorphous
Pentoxifylline
Pentoxifylline
EU DMF:US DMF No.: 20976CEP:
Polymorph form CAS No.
Form I 1677687
Phenyl salicylate
Phenyl salicylate
EU DMF:
Polymorph form CAS No.
Crystalline orthorhombic form 118-55-8
Piracetam
Piracetam
EU DMF:CEP:
Polymorph form CAS No.
Form II 7491-74-9
Prasugrel hydrochloride
Prasugrel hydrochloride
EU DMF:US DMF No.: 2016
Polymorph form CAS No.
Form B2 389574-19-0
Prasugrel maleate
Prasugrel maleate
EU DMF:US DMF No.: Q2 20
Polymorph form CAS No.
Form 1 1373350-60-
Repaglinide
Repaglinide
EU DMF:US DMF No.: 21149CEP:
Polymorph form CAS No.
Form I 135062-02-1
Risedronate sodium
Risedronate sodium
EU DMF:US DMF No.: 20384CEP:
Polymorph form CAS No. Other Documentation
Form A 329003-65-8 Japanese DMF
Salicylamide
Salicylamide
EU DMF:
Polymorph form CAS No.
Monoclinic form (space group I2/a) 65-45-2
Sildenafil base
Sildenafil base
EU DMF:US DMF No.: 28319
CAS No.
139755-83-2
Sildenafil citrate
Sildenafil citrate
EU DMF:US DMF No.: 23930CEP:
Polymorph form CAS No. Other Documentation Other Information
Anhydrous Form 171599-83-0 Japanese DMFChinese DMF Anhydrous
Sodium salicylate
Sodium salicylate
EU DMF:US DMF No.: 26873
Polymorph form CAS No.
Monoclinic form (space group P21/m) 54-21-7
Tolterodine tartrate
Tolterodine tartrate
EU DMF:US DMF No.: 24345
Polymorph form CAS No.
Form I 124937-52-6
Topiramate
Topiramate
EU DMF:US DMF No.: 20581
Polymorph form CAS No.
Orthorhombic structure 97240-79-4
Xylometazoline HCl*
Xylometazoline HCl*
EU DMF:
CAS No.
1218-35-5
Zoledronic acid
Zoledronic acid
EU DMF:US DMF No.: 24306
Polymorph form CAS No. Other Documentation Other Information
Monohydrate 165800-06-6 Japanese DMF Monohydrate

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* Polfa Warsaw API Manufacturing Site

DISCLAIMER

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

Early Development

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

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

Disclaimer

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.

Search by documentation

Product nameTherapeutic AreaPolymorph formCAS No.US DMF No.
Acenocumarol*Cardiovascular/Hypertension152-72-7
Acetazolamide Cardiovascular/HypertensionForm II59-66-510383
Alendronate sodiumMusculo-skeletal diseasesTrihydrate121268-17-516962
AniracetamCNSMonoclinic form72432-10-1
Aripiprazole CNSType I129722-12-923314
AvanafilMen's HealthCrystalline, none330784-47-929689
BaclofenMusculo-skeletal diseasesForm B1134-47-018014
Bazedoxifene acetateMusculo-skeletal diseasesForm A198481-33-3
CarbamazepineCNSForm III298-46-426266
CarvedilolCardiovascular/HypertensionForm II72956-09-317060
Carvedilol phosphate hemihydrateCardiovascular/HypertensionForm I610309-89-220633
Clopamide*Cardiovascular/Hypertension636-54-4
Cyclobenzaprine hydrochlorideMusculo-skeletal diseasesCrystalline, none6202-23-918317
EtodolacAnalgesic/InflammationCrystalline racemate, none41340-25-411405
HydrochlorothiazideCardiovascular/HypertensionForm I58-93-517599
Ibandronate sodiumMusculo-skeletal diseasesMonohydrate138926-19-925638
Lamotrigine**CNSAnhydrous monoclinic84057-84-120548
Magnesium aspartateMusculo-skeletal diseasesAmorphous28184-71-6
MetronidazoleAnalgesic/InflammationMonoclinic crystal system with space group P21/c443-48-19294
Nefopam HCl*Analgesic/Inflammation23327-57-3
Opipramol dihydrochlorideCNSAmorphous909-39-7
PentoxifyllineCardiovascular/HypertensionForm I167768720976
Phenyl salicylateAnalgesic/InflammationCrystalline orthorhombic form118-55-8
Piracetam CNSForm II7491-74-9
Prasugrel hydrochlorideCardiovascular/HypertensionForm B2389574-19-0
Prasugrel maleateCardiovascular/HypertensionForm 11373350-60-7
RepaglinideMetabolicsForm I135062-02-121149
Risedronate sodiumMusculo-skeletal diseasesForm A329003-65-820384
SalicylamideAnalgesic/InflammationMonoclinic form (space group I2/a)65-45-2
Sildenafil baseMen's Health139755-83-228319
Sildenafil citrateMen's HealthAnhydrous Form171599-83-023930
Sodium salicylateAnalgesic/InflammationMonoclinic form (space group P21/m)54-21-726873
Tolterodine tartrateUrologyForm 1124937-52-624345
TopiramateCNSOrthorhombic structure97240-79-420581
Zoledronic acid Musculo-skeletal diseasesMonohydrate165800-06-624306
Xylometazoline HCl*Analgesic/Inflammation1218-35-5

* Polfa Warsaw API Manufacturing Site

** Under registration