Carbamazepine

under development

Crystalline polymorphic form
Sacubitril/valsartan is the first agent to be approved in a new class of drugs called angiotensin receptor neprilysin inhibitor (ARNI). The medication is FDA-approved to treat patients with chronic heart failure with reduced ejection fraction (HFrEF) with NYHA class I...

DISCLAIMER Each product is protected by a patent in force in Poland and is therefore developed and manufactured solely for the purpose of Regulatory Submissions or R&D purposes. This product is not offered for sale in countries where the patent is valid and the offer or sale or any relat...

Therapeutic Area: Cardiovascular systemEU DMF available Indication: Acenocoumarol is an anticoagulant that functions as a vitamin K antagonist

Therapeutic Area: Cardiovascular systemEU DMF availableUS DMF no. 10383 availableCEP available Available also in injectable form Indication: Acetazolamide decreases the pressure in the eye and is used for adjunctive treatment of glaucoma, a condition in which increased pressure in the eye can lead to ...

Therapeutic Area: Nervous SystemEU DMF availableUS DMF no. 23314 availableCEP available Indication: used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). It is also used together with other medications to treat major depressive disorder in adult...

Therapeutic Area: Cardiovascular systemEU DMF availableUS DMF no. 17060 availableCEP available Indication: Carvedilol is a carbazole derivative acts as anti-hypertensive agent. It is formulated as tablets for oral route of administration. Carvedilol is indicated for the management of essential hypertens...

Therapeutic area: Cardiovascular systemEU DMF availableUS DMF no. 20633 available

Therapeutic Area: Cardiovascular systemEU DMF available Indication: Clopamide is indicated for the treatment of oedema, hypertension. It is formulated as tablet for oral administration. It is categorised as a thiazide like drug and works in similar way as the thiazide diuretics. It acts at the proximal c...

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...

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.