Vardenafil hydrochloride

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...

s

BRCA-mutated HER2-negative breastcancer; metastatic castration-resistantprostate cancer (with enzalutamide)

OEB 6

Crystalline

Samples: Available

Tolterodine is used in adults to treat overactive bladder with symptoms of urinary frequency, urgency, and incontinence (urine leakage).

A sulfamate-substituted monosaccharide with broad-spectrum antiepileptic activity
Polymorphic form: Orthorhombic structure

Documentation: DMF EU, DMF US, DMF Korea

Nasal preparations; a well-established nasal decongestant API used in topical formulations for the symptomatic relief of nasal congestion.

Polymorphic form: crystalline hydrochloride salt
 
Documentation: DMF EU, CEP EU

Drug description: Vismodegib is used in adults to treat basal cell carcinoma that has spread to other parts of the body (metastatic), or that has come back after surgery, or cannot be treated with surgery or radiation.

Disclaimer:Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support RegulatorySubmissions. These products are not offered for sale or made available in countries where such products are subject to patent (SPC) prote...

A first-generation H1 antihistamine with anticholinergic properties.

DMF EU

Antazoline Mesylate is the methanesulfonate (mesylate) salt of antazoline, a first-generation H1 antihistamine with anticholinergic and mild antiarrhythmic properties.

DMF EU

Antazoline Sulfate is the sulfate salt of antazoline, a first-generation H1 antihistamine with anticholinergic activity.

Crystalline

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...