Pirtobrutinib

A next-generation, orally active PI3Kα (phosphatidylinositol 3-kinase alpha) inhibitor used in targeted cancer therapy; PIK3CA-mutated HR+/HER2− locallyadvanced or metastatic breast cancer.

OEB 5

Polymorphic form: Form A

Lamotrigine is an anti-epileptic medication, also called an anticonvulsant. Lamotrigine is used alone or with other medications to treat epileptic seizures in adults and children. Lamotrigine is also used to delay mood episodes in adults with bipolar disorder (manic depression). Immediate-release...

Antisense Oligonucleotide. Used for the treatment of spinal muscular atrophy (SMA), first approved RNA-targeted therapy

Polymorphic form: Amorphous

Documentation: DMFA EU, DMA US, CADIFA

Samples: Available

Opipramol is a medication used to treat generalized anxiety and somatoform disorders.

HR+/HER2− advanced or metastatic breast cancer
Polymorphic form: Crystalline form A

Samples: Available

Documentation: DMF EU, DMF US
*Partnership with Egis

A salicylic acid derivative with mild analgesic, antiseptic, and anti-inflammatory properties.

Polymorphic form: Crystalline orthorhombic
Documentation: DMF EU

Risedronate is used to treat osteoporosis caused by menopause, or steroid use. risedronate is for use when you have a high risk of bone fracture due to osteoporosis. Risedronate is also used to treat Paget's disease of bone. Risedronate may also be used for purposes not listed in this medication ...

Crystalline polymorphic form
Sacubitril/valsartan is the first agent to be approved in a new class of drugs called angiotensin receptor neprilysin inhibitor (ARNI). The medication is FDA-approved to treat patients with chronic heart failure with reduced ejection fraction (HFrEF) with NYHA class I...

Methanesulfonate salt of safinamide, a selective and reversible monoamine oxidase-B (MAO-B) inhibitor used as an adjunct treatment for Parkinson's disease.
Crystalline anhydrous form A1

Documentation: DMF EU, DMF US

A salicylic acid derivative with analgesic and antipyretic properties, traditionally used for the symptomatic relief of pain and fever

Monoclinic form with space group I2/a

Documentation: DMF EU

A highly selective RET-driven lung, thyroid, and other solid cancers RET (Rearranged during Transfection) tyrosine kinase inhibitor used in precision oncology.

OEB 4

Sildenafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body. Sildenafil under the name Viagra is used to treat erectile dysfunction (impotence) in men. Another brand of sildenafil is Revatio, which is used to treat pulmonary arterial hypertension and i...

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.

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.

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.

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.

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.

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

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? 

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.

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.

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...