Polpharma - API manufacturer of Topiramate, Montelukast Sodium, Repaglinide, Acetazolamide, Sildenafil Citrate, Carvedilol and Alendronate Sodium

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.

FULL SUPPORT SERVICES FROM MOLECULE TO DRUG DELIVERY

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:

• Development, production and marketing of generic APIs
• Custom synthesis and toll manufacturing
• Intellectual Property review services
• Non-infringing process development
• US and European DMFs in common format
• Wide reaction classes in FDA approved facilities
• Multipurpose production lines
• High GMP standards

API MANUFACTURING

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.

ALENDRONATE SODIUM USP, PH. EUR., CEP CERTIFICATE

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).

R&D PROFILE:

• Employees - 53 highly qualified professionals including 6 with doctoral degree
• Structure - multidisciplinary teams carrying out their tasks according to the latest principles of project management
• Competences - wide spectrum of processes and technologies in-house and at business partners, experience in scale-up transfers and process improvements, and proved quality of DMF documentation – approximately 100 DMFs filled
• Innovation focus - breakthrough innovation - new API development and incremental innovation - improvement in the existing product processes
• Patent Approach - respect to the third party intellectual property rights, own patent portfolio

TOPIRAMATE, MONTELUKAST SODIUM, REPAGLINIDE

Topiramate, Montelukast, Repaglinide, Lamotrigine, Valsartan, Aripiprazole, Telmisartan, Pioglitazone, Rosiglitazone, Levetiracetam are a few examples of our recent launches and pipeline products.

CONTRACT MANUFACTURING

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.

OUT-LICENSING

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.

ACETAZOLAMIDE, SILDENAFIL CITRATE, CARVEDILOL

Our current API offer includes Acetazolamide, Baclofen, Carbamazepine, Carvedilol, Hydrochlorothiazide, Opipramol, Sildenafil citrate, Phenyl salicylate.

Please check our website for the complete product list and specifications.