Polpharma Pharmaceutical Works - API Manufacturer

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Historical background   

  • 1935 The Polish Chemical and Pharmaceutical Plant POLPHARMA is founded in Starogard Gdański, Poland.
  • 1945 As a result of the Second World War the plant is severely damaged. Reconstruction work finalizes in 1949. The first product manufactured after the war is redistillated water in ampoules.
  • 1946 The company starts the production of the first sulfonamide - prontosil rubrum. At the same time, the synthesis process of acetylsalicylic acid (ASA) is implemented.
  • 1951 The company starts the production of sulfathiazole.
  • 1956 The high quality of the acetylsalicylic acid produced and increased production capacity enable the export sales of this product. From 1985-1990 Polpharma becomes one of the world's largest producers of ASA.
  • 1995 API manufacturing facilities are approved by FDA. Positive results of an audit opens the door to the US market.
  • 2000 Polpharma is privatized based solely on Polish capital. Spectra Holding becomes the main shareholder.
  • 2004 All manufacturing processes are adjusted to meet the EU Council Directive on Integrated Pollution Prevention and Control IPPC. As a consequence, Polpharma is granted the Integrated Permit.
  • 2004 FDA positive inspections carried out at Polpharma. There is no Inspectional Observations FDA 483 Form.
  • 2005 Polpharma and the team of scientists from Gdańsk University of Technology are granted an Economic Award from the President of the Republic of Poland for the development of a new method of synthesis of alendronate sodium.
  • 2006 Completion of the modernization of a Fine Chemicals Pilot Plant. The use of state-of-the-art engineering techniques and best practices results in the creation of a modern, cGMP compliant facility.
  • 2006 Polpharma is granted GMP certificates for the production of active pharmaceutical ingredients and solid forms following the inspections condcted by the Polish Main Pharmaceutical Inspectorate.
  • 2006 Polpharma implements the Integrated Management System of Environmental Health and Safety. The company is granted ISO 14001:2004 and OHSAS 18001:1999 accreditations.
  • 2009 Polpharma Fine Chemicals is successfully inspected by the FDA for 6 ANDAs and 1 NDA for the US market. Just as in the last inspection there is no 483 observations issued.
  • 2009 Polpharma is granted subsidies from the European Union for the execution of 6 R&D projects, 4 of which are focused on Fine Chemicals Business Unit.
  • 2009 The company enters into agreements with external partners: cooperation agreement with Syncom to use biocatalysis for the synthesis of chiral intermediates and chiral APIs, and with Dishman Pharma on joint API development.
  • 2010 Polpharma consolidates its position as a global player by entering the Japanese, Korean and Australian generic markets.

 

Latest news

CEP for Baclofen available

Monday, 02-01-2012
Polpharma has been granted Certificate of Suitability (CEP) by the European Directorate for the Quality of...

Polpharma – the most innovative company in Poland

Friday, 20-05-2011
Polpharma ranked first as the most innovative company in Poland, in a research study run by the Institute...

Polpharma has inaugurated a new state of the art 300 sq.m. Process Development Labs complex

Friday, 08-10-2010
Polpharma has inaugurated a new state of the art 300 sq.m. Process Development Labs complex for the...

Co-operation between Polpharma and RPG Life Sciences

Tuesday, 05-10-2010
RPGLS and Polpharma announced their co-operation in the development and manufacture of Active...
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