Isavuconazole sulfate

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)

...

Piracetam
Form II

> Capacity and flexibility to cover high-volume demand
oral & injectable forms

CEP, 
BRAZILIAN DMF"

DISCLAIMER

Products protected by valid patents are not offered for sale in cou...

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...

Polpharma API • OEB 4 • Under development

Aniracetam is a cognitive enhancer employed to improve memory and attention issues associated with cerebrovascular conditions and degenerative brain diseases.

Polpharma API

Drug descriptionBrexpiprazole is an antipsychotic medication that is used to treat the symptoms of schizophrenia. It is also used together with other medications to treat major depressive disorder in adults. Brexpiprazole may also be used for purposes not listed in this...

Gilteritinib is an AXL receptor tyrosine kinase inhibitor used to treat relapsed or refractory acute myeloid leukemia.

Ibandronate is a bisphosphonate medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures. Ibandronate is used to treat or prevent osteoporosis in women after menopause. Ibandronate may also be used for purposes not listed in this med...

Lamotrigine is an anti-epileptic medication, also called an anticonvulsant. Lamotrigine is used alone or with other medications to treat epileptic seizures in adults and children. Lamotrigine is also used to delay mood episodes in adults with bipolar disorder (manic depression). Immediate-release...

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.