Polpharma Group

Therapeutic Area: Cardiovascular system
EU DMF 
Indication: Acenocoumarol is an anticoagulant that functions as a vitamin K antagonist
• Long experience in  in-house commercial manufacturing • No risk of  nitrosoamine presence

Therapeutic Area: Cardiovascular system 
EU DMF
US DMF

Korean DMF
Japanese DMF
CEP available 
Available also in injectable form Indication: Acetazolamide decreases the pressure in the eye and is used for adjunctive treatment of glaucoma, a condition in which increa...

Therapeutic Area: Nervous SystemEU DMF availableUS DMF no. 23314 availableCEP available Indication: used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). It is also used together with other medications to treat major depressive disorder in adult...

Therapeutic Area: Nervous System EU DMF availableUS DMF no. 26266 availableCEP available Indication: Carbamazepine is an anticonvulsant and mood-stabilizing drug used primarily in the treatment of epilepsy and bipolar disorder, as well as trigeminal neuralgia.

Therapeutic Area: Cardiovascular systemEU DMF availableUS DMF no. 17060 availableCEP available Indication: Carvedilol is a carbazole derivative acts as anti-hypertensive agent. It is formulated as tablets for oral route of administration. Carvedilol is indicated for the management of essential hypertens...

Carvedilol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins). Carvedilol is used to treat heart failure and hypertension (high blood pressure). It is also used after a heart attack that has caused your heart not to pump as well. Carvedilol m...

Clopamide is an oral diuretic with antihypertensive properties. Similar to thiazide diuretics, it features an aromatic sulfonamide base, but it lacks a double-ring structure.

Polpharma API • Long experience in  in-house commercial manufacturing • All intermediates  produced in-h...

Therapeutic Area: Musculo-skeletal systemEU DMF availableUS DMF no. 11405 availableJapanese DMF availableCEP available Indication: Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) used for the management of mild to moderate pain, fever, and inflammation.

Tadalafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body. Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate). Another brand of tadalafil is Adcirca, wh...

Ticagrelor 

form II 

Own process patent to free from nitrosamines 

CEP, 
US DMF, 
EU DMF,  
Korean DMF, 
Canadian DMF, 
Cadifa

DISCLAIMER

Products protected b...

Hydrochlorothiazide

Therapeutic Area: Cardiovascular system • EU DMF available • US DMF no. 17599 available • Japanese DMF available  • CEP available  
DISCLAIMER

Products protected by valid patents are not offered for sale in countries where the sale of ...

Alendronate Sodium
Trihydrate

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

CEP, 
US D...

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.