Polpharma – API Manufacturer

Polpharma Fine Chemicals Business Unit is a world-class manufacturer. It is the largest producer of active pharmaceutical ingredients (API) in Poland with 75 years of experience in the production of pharmaceuticals.

Our goal is to manage innovation with good practices, understand customers' needs and provide the best solutions for them. We are focusing our efforts on modernising the API portfolio and expanding it with new, attractive products.

Our mission is the reliable delivery of APIs as early as possible in the product development phase so our customers can improve their time to market with a secured quality of new molecules losing patent protection.

Manufacturing of APIs is carried out in GMP-compliant and FDA-approved multipurpose facilities. The company products are sold to leading generic companies worldwide and our goal is to maintain a good relationship and a cost competitive service throughout the product's entire life cycle.

Full support services from molecule to drug delivery

Polpharma provides a one-stop shop solution of 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.

API manufacturing

API manufacturing is carried out in cGMP-compliant and FDA-approved multipurpose plants.

We offer:

• cGMP compliance
• US DMFs, EU DMFs in CTD format and CEP certifications
• Custom synthesis and toll manufacturing
• Intellectual property review services
• Non-infringing process development
• Wide reaction classes in FDA approved facilities
• Green chemistry program
• Environmental sustainability program

Quality and documentation

Polpharma meets the strict FDA requirements and Current Good Manufacturing Practice (cGMP) guidelines. We prepare DMF documentation for all products in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD) and FDA (US DMF).

Development and commercialisation of new APIs

The priority of Polpharma's Fine Chemicals R&D department is the development and commercialisation of new attractive APIs.

R&D profile:

• Employees – 37 highly qualified professionals including nine with doctoral degrees
• 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 with business partners, experience in scale-up transfers and process improvements, and proved quality of DMF documentation – approximately 220 DMFs filed
• Innovative focus – breakthrough innovation – new API development and incremental innovation – improvement in the existing product processes
• Patent approach – respect to third party intellectual property rights and own patent portfolio

Toll and custom manufacturing

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

Out-licensing is realised in strategic alliance with Farmaprojects, Spain. 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.

For the complete product list please visit our website.

Contact details

Polpharma SA Pharmaceutical Works
Fine Chemicals Business Unit
19 Pelplinska
83-200 Starogard Gdanski
Poland

Tel: +48 58 563 21 20-23 / 25-26
Fax: +48 58 563 21 24
api@polpharma.com
www.api.polpharma.pl
www.polpharma.pl