Dapagliflozin

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.

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...

Enzalutamide 
Anhydrous form R1 

CAS No: 915087-33-1
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 respon...

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 ...

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.

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.

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

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.

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.