Polpharma Fine Chemicals Business Unit is a world-class manufacturer. It is the largest producer of Active Pharmaceutical Ingredients (API) in Poland with over 70 years of experience in the production of pharmaceuticals. API manufacturing is carried out in GMP-compliant and FDA-approved multipurpose facilities. The company products are being sold to leading generic companies worldwide.
Polpharma provides a one-stop shopping solution for vertically integrated services from API development to finished dosage formulation along with scale-up capabilities based on in-house or customer developed technology and support of the registration file.
Our offer includes:
We combine science and expertise to deliver attractive solutions for drug development. Our systems and state-of-the-art manufacturing facilities have successfully passed FDA inspections and have gained the trust of our customers worldwide.
Our list of APIs includes the following quality products: topiramate, montelukast sodium, repaglinide, acetazolamide, sildenafil citrate, carvedilol, and alendronate sodium.
Our achievements include the successful development of a unique and innovative method for manufacturing alendronate sodium, one of the most effective compounds used to treat osteoporosis.
DMF documentation for all products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD) and FDA (US DMF).
Topiramate, Montelukast, Risedronate sodium, Lamotrigine, Metronidazole, Repaglinide, Aripiprazole, Tadalafil, Trandolapril, Ziprasidone and Zolendronate are a few examples of our recent launches and pipeline products.
In addition, Polpharma provides a wide range of toll and custom manufacturing capabilities. We have the ability to provide customers with materials ranging from clinical quantities up to in-market supply. Complete vertical integration of processes from R&D to pilot plant, scale-up and manufacturing leverages our competences to provide cost-effective and on time solutions to our partners.
Our services include EU standard dossiers for finished dosage formulations based on APIs developed in-house or sourced externally. Our out-licensing portfolio provides the most comprehensive offer for our customers.
Our current API offer includes Acetazolamide, Baclofen, Carbamazepine, Carvedilol, Ethenzamide, Hydrochlorothiazide, Opipramol, Pentoxifylline, Phenyl salicylate, Sodium salicylate, Salicylamide, Sildenafil citrate.
Fine Chemicals Business Unit
83-200 Starogard Gdanski
Tel: +48 58 563 21 20-23
Tel: +48 58 563 21 25-26
Fax: +48 58 563 21 24