Piracetam

Apixaban

Polymorphic form N-1

> No risk of nitrosamines > Eco friendly process
> PSD flexibility via micronization

EU DMF, 
US DMF, 
KOREAN DMF
DISCLAIMER

Products protected by va...

Empagliflozin

CRYSTALLINE ANHYDROUS

> Cryogenic process
> Green chemistry

EU DMF, 
US DMF, 
CHINESE DMF, 
KOREAN DMF

DISCLAIMER

Products protected by valid patents...

Baclofen
FORM B

Own innovative process

Global market leader
CEP, US 
DMF, 
JAPANESE DMF, 
KOREAN DMF, 
CANADIAN DMF

DISCLAIMER

Products protected by valid patents are not offered for s...

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)

...

Linagliptin

Mix A&B

> White API color
> Better impurity profile


DISCLAIMER

Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. It ...

Elagolix belongs to a class of drugs called gonadotropin-releasing hormone (GnRH) receptor antagonist. It is an oral tablet used to help treat pain caused by endometriosis .Endometriosis is a condition where tissue that should line the uterus or womb, grows outside of the uterus forming lesions. ...

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...

Isavuconazonium is used to treat infections caused by certain types of fungus (aspergillosis or mucormycosis).Isavuconazonium may also be used for purposes not listed in this medication guide.

Polpharma API • Innovative manufacturing process • Chemical purity above 99,5%

Polpharma API • OEB 4 • Under development

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.

Thanks to over 75 years of experience in process development, scale-up and cGMP manufacturing, we support both emerging and established pharmaceutical customers in the development and commercialization of their small molecule API clinical candidates and CDMO service. At our FDA-approved plant located in Central Europe, we provide end-to-end solutions from API development to scale-up allowing smooth process transfer for commercial-scale manufacturing capabilities, with world-class regulatory support. 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.

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.

As an EU-based Contract Development and Manufacturing Organization (CDMO) and supplier of active pharmaceutical ingredients, we are advancing our technology capabilities with an Occupational Exposure Limit (OEL) as low as 10 ng/m³ (OEB 6).
Our new capabilities enable GMP and FDA-approved kilo-scale production, offering batch sizes of up to 1.5 kg. This facility features dedicated Analytical Development Laboratories (ADL) and Process Development Laboratories (PDL) to ensure comprehensive support for all production phases. The design incorporates state-of-the-art isolator technology to ensure the safety of both personnel and products, along with industry-standard secondary containment solutions integrated into the infrastructure.
We have secured future capacity expansion through both internal enhancements and external partnerships, with the goal of doubling our production capacity.

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? 

KiloLab Laboratory – a development and production in a kilogram scale – has been launched, according to Polpharma API development strategy adopted in 2021.