Risedronate sodium

Therapeutic Area: Cardiovascular system • EU 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 p...

Therapeutic area: Cardiovascular system • EU DMF available • US DMF no. 20633 available 

Therapeutic Area: Musculo-skeletal system • EU DMF available • US DMF no. 11405 available • Japanese DMF available • CEP available

Indication: Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) used for the management of mild to moderate pain, fever, and inflammation.

Therapeutic Area: Musculo-skeletal system • EU DMF available • US DMF no. 25638 available • Chinese DMF - under registration

Indication: Ibradronic Sodium is a potent bisphosphonate drug used in the prevention and treatment of osteoporosis

DISCLAIMER

The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP...

Therapeutical Area: Musculo-skeletal system • EU DMF available • US DMF no. 18014 available • Japanese DMF available • CEP available
Indication: Baclofen is primarily used for the treatment of spastic movement disorders and alcoholism.

Therapeutic Area: Cardiovascular system • EU DMF available • US DMF no. 17599 available • Japanese DMF available  • CEP available

Indication: Hydrochlorothiazide is a diuretic drug of the thiazide class that acts by inhibiting the kidneys' ability to retain water. This reduces the volum...

Therapeutic area: genito-urinary system & sex hormones

EU DMF available

US DMF : 24590

CEP available

Therapeutic Area: Musculo-skeletal system • EU DMF available • US DMF no. 16962 available • Japanese DMF available • CEP available

Indication: Alendronate sodium is a bisphosphonate drug used for osteoporosis and several other bone diseasesMusculo-skeletal diseases

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

Therapeutic Area: Cardiovascular system • EU DMF available • US DMF no. 10383 available • CEP 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 ...

Therapeutic Area: Nervous System • EU DMF available • US DMF no. 23314 available • CEP 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 depr...

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.

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024 with full completion scheduled for Q3 2024.

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

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. 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! 

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.

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.

In July 2018, the pharmaceutical industry was shaken when nitrosamine impurities were detected in human medicines, leading to recalls of several batches of high blood pressure and heart failure med valsartan. Investigations by health authorities and drug companies revealed that nitrosamines are generated during the synthesis of active pharmaceutical ingredients (APIs). Read our safe approach in delivering nitrosamine-free at Polpharma API products.

Karina Boszko, head of API Regulatory Affairs and Customer Technical Support Department, explains how we at Polpharma undertake this challenge.


The full article available: https://www.api.polpharma.com/news/safe-approach-in-delivering-nitrosamine-free-api-products/

In the pharmaceutical industry, particle size has become one of the key aspects inthe development of the active pharmaceutical ingredients (APIs) and qualitycontrol of solid oral dosage forms. The physicochemical and biopharmaceutical properties of biologically active substance can be highlyaffected by crystal size and its distribution (CSD), also called as particle size distribution (PSD). According to thelatest scientific reports, it is estimated that almost 80% of new promising molecules having biological activity are rejected during the research and development process due to the low water solubility what is strongly related tothe bioavailability and release of the drug. Polpharma API has many years of experience in delivering APIs with the right particles size distribution through crystallization, milling/micronization, vibration sieving or other technologies. Learn more from our experts!

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]

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.

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.

You can read a full article: https://www.api.polpharma.com/news/polpharmas-strategic-investment-in-hpapi-facility-the-first-of-this-kind-in-poland/