Etodolac

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...

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...

Pentoxifylline
Form I
Pentoxifylline is a methylxanthine derivative employed to treat intermittent claudication resulting from chronic occlusive arterial disease in the limbs.

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Polpharma API • Extensive production experience • Tailor made PSD • Oral & injectab...

Dapagliflozin
amorphous & propanediol

> Cryogenic process
> Green Chemistry

EU DMF
US DMF
Korean DMF
Canadian DMF 
DISCLAIMER

Products protected by valid patents are not offer...

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? 

Thanks to over 70 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. 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.

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

Thanks to over 70 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. 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.

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.