Polpharma Pharmaceutical Works - API Manufacturer

Successful FDA inspection

Between 26 and 29 January 2009, Polpharma Fine Chemicals were inspected by the FDA (the U.S. Food and Drug Administration) for 6 ANDAs (Abbreviated New Drug Applications) and 1 NDA (New Drug Application) for the US market. Like the last inspection there were no 483 observations issued.

Polpharma Fine Chemicals Operations and Quality Systems passed successfully this preapproval inspection likewise in 2004.

The FDA inspections are of importance for our company because if successfully passed, allow to export our products to the US market, offer our value proposition to customers, expand sales and open up business development opportunities in this highly competitive and demanding market.

Such a result reaffirms that the Polpharma Fine Chemicals Business Unit is able to deliver quality of service and value, in an ever-stricter regulatory environment, while the FDA is exercising stronger investigative powers.

Product safety is our top priority and we envision to be recognized as a company, which successfully markets products that extend and enhance the quality of human life, and which offers competitively differentiated APIs (Active Pharmaceutical Ingredient).