Piracetam

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...

Zoledronic Acid

Monohydrate

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

...

Linagliptin

Mix A&B

> White API color
> Better impurity profile


DISCLAIMER

Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. It ...

Elagolix belongs to a class of drugs called gonadotropin-releasing hormone (GnRH) receptor antagonist. It is an oral tablet used to help treat pain caused by endometriosis .Endometriosis is a condition where tissue that should line the uterus or womb, grows outside of the uterus forming lesions. ...

Pimavanserin is an antipsychotic medicine that works by changing the actions of chemicals in the brain. Pimavanserin is used to treat hallucinations and delusions caused by psychosis that is related to Parkinson's disease. Pimavanserin may also be used for purposes not listed in this medication g...

Sitagliptin is an oral DPP-4 inhibitor used alongside diet and exercise to enhance glycemic control in individuals with type 2 diabetes mellitus. This medication works by increasing insulin and decreasing glucagon in a glucose-dependent manner, thereby improving blood sugar regulation.

P...

Isavuconazonium is used to treat infections caused by certain types of fungus (aspergillosis or mucormycosis).Isavuconazonium may also be used for purposes not listed in this medication guide.

Polpharma API • Innovative manufacturing process • Chemical purity above 99,5%

Polpharma API • OEB 4 • Under development

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.