Polpharma S.A.

Therapeutic Area: Cardiovascular system
EU DMF 
Indication: Acenocoumarol is an anticoagulant that functions as a vitamin K antagonist
• Long experience in  in-house commercial manufacturing • No risk of  nitrosoamine presence

Therapeutic Area: Cardiovascular system 
EU DMF
US DMF

Korean DMF
Japanese DMF
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 increa...

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: Nervous System EU DMF availableUS DMF no. 26266 availableCEP available Indication: Carbamazepine is an anticonvulsant and mood-stabilizing drug used primarily in the treatment of epilepsy and bipolar disorder, as well as trigeminal neuralgia.

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...

Thanks to over 75 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 and CDMO service. 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.