Toll & custom manufacturing / World class service / Polpharma Pharmaceutical Works

Toll & custom manufacturing

Our cGMP capacity combined with a short development time and competitive pricing make us a natural first choice for pharmaceutical companies interested in outsourcing their manufacturing activities.

What can we offer our partners?

Wide reaction classes in FDA approved facilities
State-of-the-art technology and best design processes and practices
Low cost, highly skilled workforce
Own R&D resources including pilot plant and wide cooperation with external research and academic institutions and laboratories

What makes us different from other competitors?

Full scale and vertical integration of processes from R&D and the GMP Pilot plant, scaling up to manufacturing
Highly skilled workforce with an ever increasing proportion of university graduates at a relatively low cost
Low cost environment thanks to the competitive labor cost and location of the entire manufacturing site in an economic zone

Legislation benefits

Legislation Benefit

Product patent law introduced in 1993 with grandfathering previous process patent status.

Molecules with product patents granted up to 1993 do not come under patent protection. It enables us to develop alternative processes for the synthesis of attractive compounds.

The Bolar-Roche provision.

Development work on patented products can start prior to the patent expiration date.

The SPC regime applies to products that were protected by a valid patent on the date of Poland's accession to the EU and obtained their first marketing authorization in Poland or the EU after January 1, 2000.

Shorter patent protection period for APIs authorized before January 1, 2000.

The preferential intellectual property status is an opportunity for the development of alternative processes for the synthesis of commercially attractive compounds for sales in countries such as Poland, which recently adopted the product patent.

Polpharma Pharmaceutical Works - API Manufacturer

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