Isavuconazole sulfate

Rivaroxaban

MODIFICATION I

> No risk of presence of nitrosamines
> Innovative crystalization obtaining material of high purity

CEP, 
US DMF, 
CHINESE DMF, 
KOREAN DMF 
DISCLAIMER ...

Trametinib

DMSO solvate

Oncology

OEB 5
DISCLAIMER

Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. It is within the buyer’s responsibility and liability...

Zoledronic Acid

Monohydrate

> No risk of presence of nitrosamines
> Long experience with commercial manufacturing
> In-house production of the whole product family (Risedronate, Alendronate, Ibandronate)

...

Piracetam
Form II

> Capacity and flexibility to cover high-volume demand
oral & injectable forms

CEP, 
BRAZILIAN DMF"

DISCLAIMER

Products protected by valid patents are not offered for sale in cou...

Pimavanserin is an antipsychotic medicine that works by changing the actions of chemicals in the brain. Pimavanserin is used to treat hallucinations and delusions caused by psychosis that is related to Parkinson's disease. Pimavanserin may also be used for purposes not listed in this medication g...

Sitagliptin is an oral DPP-4 inhibitor used alongside diet and exercise to enhance glycemic control in individuals with type 2 diabetes mellitus. This medication works by increasing insulin and decreasing glucagon in a glucose-dependent manner, thereby improving blood sugar regulation.

P...

Polpharma API • OEB 4 • Under development

Aniracetam is a cognitive enhancer employed to improve memory and attention issues associated with cerebrovascular conditions and degenerative brain diseases.

Rheumatoid arthritis, alopecia areata, atopic dermatitis
Polymorphic Form 1

OEB 4

Status: Pipeline

Documentation: US DMF, EU DMF, Korean DMF

Samples: Available

Polpharma API

Drug descriptionBrexpiprazole is an antipsychotic medication that is used to treat the symptoms of schizophrenia. It is also used together with other medications to treat major depressive disorder in adults. Brexpiprazole may also be used for purposes not listed in this...

First-generation H1 antihistamine used for the treatment of allergic conditions such as allergic rhinitis, urticaria, and pruritus. It provides potent antihistaminic activity and is characterized by a rapid onset and long duration of action.
Clemastine Fumarate, a crystalline salt form

Do...

An orally active, selective sphingosine-1-phosphate (S1P) receptor modulator that targets S1P₁, S1P₄, and S1P₅ receptors.

* Partnership with Egis







Disclaimer:Products protected by patents (SPC) in Poland are developed solely for the purpose of Regula...

Polpharma API has been selected by Celon Pharma to support the development and manufacturing of a payload-linker compound for an innovative ADC oncology program. The collaboration combines Celon Pharma’s proprietary therapeutic platform with Polpharma API’s expertise in high-potency manufacturing and GMP-compliant development, highlighting the growing importance of specialized partnerships in advancing next-generation cancer therapies.

European API Supplier Built for Complex Challenges

With over 75 years of manufacturing experience, Polpharma API delivers advanced API and CDMO solutions to more than 500 customers in 70+ countries. Operating from two GMP manufacturing sites in Poland, the company specializes in generic APIs, HPAPIs, oligonucleotides, and payload-linker intermediates.

Its integrated platform combines process development, advanced analytics, QC, containment, and GMP manufacturing, supporting complex projects from development to commercial supply. Key capabilities include HPAPI manufacturing up to OEB 6, solid-phase oligonucleotide synthesis, chromatography, UF/DF, lyophilization, and advanced chemistry for payload-linker development.

For generic manufacturers, Polpharma API provides a reliable European supply chain. For CDMO partners, it offers a collaborative path from complex chemistry and analytical development to robust, reproducible GMP production.

We invite you to explore Polpharma API’s HP API manufacturing – virtually!Transparency and trust start with understanding how your API is manufactured.That’s why we invite you to experience our 360° virtual tour of Polpharma API’s High Potency API facility.

We are one of the leading European CDMO companies with over seven decades of experience in supporting patients’ health ​with high-quality APIs.

Our collaborative approach means you're not hiring a facility—you're partnering with a highly qualified team, guiding development, scaling processes, and staying fully accountable from first touch to final batch. Our strong R&D management team, experienced in the development of chemical processes and complex projects, provides a wide range of solutions to our customers, applying a variety of chemical reactions and conditions, including cryogenic, High Pressure, strong base reactions, and tailor-made particle size distribution modifications. At Polpharma quality comes first. Regular FDA audits prove our reliability and credibility towards business partners around the world.

Spinal muscular atrophy (SMA) is a rare but devastating genetic disorder that affects the motor neurons responsible for muscle movement. Without treatment, it leads to progressive muscle weakness, loss of mobility, and in severe cases, early death1. While medical innovation has brought new hope to SMA patients, access to treatment remains a global challenge — one that generic API suppliers are uniquely positioned to help solve.

Polpharma API: 75 Years of Precision. Built for What’s Next.

Cancer cases are expected to increase by 61% by 2050, particularly in lower-income countries. This alarming trend underscores the urgent need for more effective and targeted treatment options. In response to this, the pharmaceutical landscape has seen a significant shift towards the development and use of Highly Potent Active Pharmaceutical Ingredients (HPAPIs), especially in oncology.

Did you know you can explore Polpharma API without leaving your desk?

Our Virtual Tour platform offers an inside look at our facilities, technologies, and capabilities, allowing you to discover our operations from anywhere in the world.

Take a virtual walk through Polpharma API and see where innovation meets manufacturing excellence.

Explore the tour and experience our facilities online.

Diabetes is one of the most serious health problems in the modern world. Currently about 537 million adults live with diabetes worldwide and this number is rising significantly each year. It is expected to reach 643 million patients by 2030 and 783 million by 2045. Rising prevalence of diabetes results in placing this condition in the top 10 contributors to DALYS2 and causes 6.7 million deaths annually. As for now, there is no drug that can permanently cure diabetes. Therefore, treatment is based on the management of the disease with the support of medications helping control the sugar levels. This contributes to better quality of patient life and limiting outcomes from the disease.

Where HP API development begins?
Behind every successful highly potent API is a strong development foundation.In this video, we take you inside the place where around 30 experienced chemists work on drug substance processes — from early development to the first GMP phase.

 Watch the full video to see how we support CDMO projects through:
- Development of drug substance manufacturing processes at various stages
- Scale‑up from R&D to first GMP
- A dedicated HP API facility designed for the most demanding compounds
- Safe handling of substances with OEL as low as 10 ng/m³


This is where expertise, containment, and CDMO know‑how come together.

This year at CPHI Barcelona (24–26 October, 2023) we sat down with C-suite executives and HR professionals to discuss the looming talent crisis in the pharmaceutical industry. With hybrid working persisting post-pandemic and a growing skills gap, how can the pharmaceutical supply chain adjust to a changing labour force? 

In our laboratories, we work with a broad range of compounds, including highly potent drug substances (OEB up to 6). 
To meet the highest safety and quality standards, all powder handling is carried out in fully contained isolators — protecting our teams and giving our partners full confidence in project execution.


Our HP API Analytical Development dedicated infrastructure includes:
✔5x Isolators
✔12x Fume Hoods
✔5x Ventilated Enclosures
- HPLC with detectors: UV-Vis (PDA), RI
- UPLC with detectors: UV-Vis (PDA), RI, MS, FLR
- SFC (UPC2, Ultra-performance Supercritical Fluid Chromatography)


Backed by an experienced expert team and a strong commitment to quality, we are ready to support your next project — from challenge to delivery. 
Watch the full video to learn more.

In this video, we open the doors to our high‑potent installation designed for the most demanding molecules, payloads andlinkers.
Discover how we turn highly potent challenges into safe, scalable solutions.


➡OEB 6 containment – down to 10 ng/m³
➡Isolator‑based production lines for maximum safety
➡Cryogenic reactions down to –90°C
➡Seamless tech transfer thanks to direct access to HP R&D labs
➡Batch sizes up to 2 kg
➡Continuous 24/7 operations supporting timely project delivery


 Proudly joining the forefront of European #HPAPI and GMO manufacturers.

Thanks to over 75 years of experience in process development, scale-up and cGMP manufacturing, we support both emerging and established pharmaceutical custom...