Enzaluthamide

Therapeutic area: genito-urinary system & sex hormones EU DMF available US DMF : 24590 CEP available

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

> Very long production experience
> Tailor made PSD

CEP, 
US DMF, 
CHINESE


This product is not offered for sale or made available in countries where it is subject to patent (SP...

Dapagliflozin
amorphous & propanediol

> Cryogenic process
> Green Chemistry

EU DMF
US DMF
Korean DMF
Canadian DMF 
DISCLAIMER

Products protected by valid patents are not offer...

Palbocyclib

CRYSTAL FORM A
US DMF pending

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 liab...

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...

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? 

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.

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

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]

Polpharma’s strategic investment in HPAPI facility, the first of this kind in Poland and one of the most advanced in Central Easter Europe.

Check out how we can create business value together in the whole pharmaceutical value chain, including API, B2B, commercial partnerships and other forms of collaboration. In the video: Markus Sieger, CEO of Polpharma Group, David Gonzalez, Commercial Director of API Business Unit, Mieczyslaw Starkowicz, Head of B2B Venture and Simon Clark, Commercial Director for Polpharma Group and strategic partners.

We offer an attractive portfolio of FDF focused on the newest and most prescribed therapies, having a customer centric approach through a multidisciplinary support team: Sales, Marketing, R&D, RA, QA&QC, IP, etc. Due to combined efforts of Polpharma and its strategic partner Farmaprojects we guarantee supply continuity in EU and non-EU territories.

In 2022, we are opening a new chapter in the history of Polpharma in the field of ​​active substances. With the strategic investment in a HPAPI facility, Polpharma and Poland are becoming a strong pillar of the European pharmaceutical industry in the coming decades.

Grand opening of new R&D & Production Facility in Q3 2024

Completion of this investment is scheduled for the first quarter of 2024. It will include separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing Quality Control analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

Use link to read more: https://www.api.polpharma.com/news/polpharmas-strategic-investment-in-hpapi-facility-the-first-of-this-kind-in-poland/

Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.