Polpharma Group Polphar

Ticagrelor 

form II 

Own process patent to free from nitrosamines 

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

Hydrochlorothiazide

Therapeutic Area: Cardiovascular system • EU DMF available • US DMF no. 17599 available • Japanese DMF available  • CEP available
Indication: Hydrochlorothiazide is a diuretic drug of the thiazide class that acts by inhibiting the kidneys' abilit...

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 DMF, 
JAP...

We manufacture our products by following our customers' and health authorities' most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.

In July 2018, the pharmaceutical industry was shaken when nitrosamine impurities were detected in human medicines, leading to recalls of several batches of high blood pressure and heart failure med valsartan. Investigations by health authorities and drug companies revealed that nitrosamines are generated during the synthesis of active pharmaceutical ingredients (APIs). Read our safe approach in delivering nitrosamine-free at Polpharma API products.

Karina Boszko, head of API Regulatory Affairs and Customer Technical Support Department, explains how we at Polpharma undertake this challenge.


The full article available: https://www.api.polpharma.com/news/safe-approach-in-delivering-nitrosamine-free-api-products/

In the pharmaceutical industry, particle size has become one of the key aspects inthe development of the active pharmaceutical ingredients (APIs) and qualitycontrol of solid oral dosage forms. The physicochemical and biopharmaceutical properties of biologically active substance can be highlyaffected by crystal size and its distribution (CSD), also called as particle size distribution (PSD). According to thelatest scientific reports, it is estimated that almost 80% of new promising molecules having biological activity are rejected during the research and development process due to the low water solubility what is strongly related tothe bioavailability and release of the drug. Polpharma API has many years of experience in delivering APIs with the right particles size distribution through crystallization, milling/micronization, vibration sieving or other technologies. Learn more from our experts!

Recent investments in Polpharma API’ capabilities will support a strategic move into complex API development and manufacturing for CDMO partners and generics companies worldwide, empowering the global supply chain.Visit us and learn how Polpharma API enters into a strategic transformation process that aims to invest in new capabilities and technologies like high containment or cryogenic to be fully implemented by 2026. However, our production capacity will increase significantly already from mid-2023!

Would like to meet our representatives and learn more, please contact us today: [email protected]; [email protected]