Our broad and varied portfolio and years of experience allow us to offer modern products and solutions to pharmaceutical companies worldwide. About 20% of the substances we manufacture are used for the production of our own finished drug forms. The rest is intended for external companies, 95% of which is exported, mainly to other EU countries and to North America, Latin America, North Africa, Korea and Japan. We are present on 6 continents, and our market position is growing.

The total capacity of our reactors for substance synthesis is 350,000 litres. Our manufacturing facilities are subject to rigorous inspections by the US Food and Drug Administration (FDA). All FDA inspections (in 2004, 2009, 2012 and 2015) conducted so far have resulted in no objections being raised.

For more information log on to www.api.polpharma.com

For any inquiries on contract manufacturing, please e-mail: salesb2b@polpharma.com

Thanks to our high quality and certification from the most demanding supervision institutions in the world (the US FDA), we can offer substances for the most restrictive markets – in Korea, USA, EU5, and Japan. These include such substances as baclofen, aripiprazole, tadalafil, vardenafil, alendronate, risedronate, sildenafil, hydrochlorothiazide, and xylometazoline.

Additionally, 19 substances are vertically integrated, i.e. used for the production of ready-made pharmaceutical forms. These include such substances as sildenafil, piracetam, pentoxifylline, metronidazole, hydrochlorothiazide, and etopyrine.

We also have suppliers in various parts of the world, and we audit them at the place of manufacture. Polpharma’s API production areas are subjected to rigorous inspections by the US FDA. We have recently undergone FDA inspections – in 2004, 2009, 2012, 2015 and 2018 – and all have been successful, which confirms our reliability and credibility among business partners around the world.

Audits in numbers

2018:

• Number of Audits: 45 audit days and inspections; 29 customers
• Number of Inspections: 4-3 x GIF, 1 x US FDA US FDA inspection at the API Plant carried out
• All audits and inspections completed with a positive result

2017:

• Number of Audits: 44 audit days and inspections; 39 customers
• Number of inspections 3: 2 x GIF (Polish ministry), 1X MIT (Russian ministry)
• All audits and inspections completed with a positive result

At Polpharma’s API plant, we also minimise the impact of our operations on the natural environment, which is confirmed by numerous certificates, including ISO 14001: 2004 (UKAS accreditation), as well as conducting rational waste management (own waste incineration plant; capacity 200 kg / h, solids and liquids).

The R&D API department has world-class analytical equipment, often not available even in scientific and research facilities, enabling such activities as the development of new analytical methods. Further innovations are also planned, including the implementation of innovative technological solutions such as microreactors and continuous processes (advanced works), and further improvement of production processes, including the introduction of biocatalysts and new techniques for isolating products.

Thanks to such cooperation, employees of the Research and Development Department have access to information and the latest scientific data, which in turn allows the improvement of existing technologies as well as the development of completely new, innovative solutions that improve the cost-effectiveness of processes as well as their environmental safety.

Polpharma also received two awards from the President of the Republic of Poland for its activities in the area of API:

• Economic Award of the President of the Republic of Poland in the category “Invention in the field of product or technology” for developing together with the Gdańsk University of Technology, a new, fully original method of obtaining alendronate sodium, one of the most effective substances in the world in the fight against osteoporosis (2005);
• and an award in the “Innovativeness” category for the development of innovative technologies and implementation into production of a series of active substances from the group of anti-osteoporosis drugs: sodium alendronate, sodium risedronate, zoledronic acid and sodium ibandronate (2013).

Polpharma has the only API plant in Poland that manufactures on such a large scale

Polpharma has unique equipment in Poland, enabling such activities as:

• shorter development time
• development of new polymorphic forms (better therapeutic effect)
• generation of data on the safety of reactions

1. We have world-class analytical equipment often unavailable even in scientific research facilities, enabling such activities as the development of analytical methods
2. Applied solutions:

• classic and novel methods to obtain “Difficult to make” methods of obtaining chemical compounds (API)
• specific methods and technologies resulting from possessed “Know-How”
• huge potential of young, well-educated people What are we planning?
• implementation of innovative technological solutions such as microreactors, continuous processes (advanced works)
• further improvement of manufacturing processes, including the introduction of biocatalysts and new techniques for isolating products