Medichem's solid dosage form plant approved by US FDA
The dosage form facility near Malta’s airport – which makes tablets and capsules for a variety of international markets – passed the US Food and Drug Administration (FDA) audit last month.
The firm operates two active pharmaceutical ingredient (API) manufacturing facilities – one on Malta and one in Spain – which have both been approved by the US regulator.
Medichem said: “Following the positive outcome of the audit, all Medichem’s European manufacturing sites for API and FDF are now FDA inspected.
“This extends the scope of the company’s FDF business to the US and emphasizes the company’s interest and commitment to this market.”
API supply
Medichem claims to supply 40 APIs to customers in the US.
When the firm open the Malta API plant in 2014 it highlighted the country's patent laws as an important part of its decision to set up the facility, explaining that the island's “legal and intellectual property (IP) framework allows Medichem to offer first-to-market opportunities to its customers worldwide.”
Malta’s attraction as a drug production hub is dependent on two factors: the small size of the market, which means that comparatively few drug patents have been registered in the country; and its broad interpretation of legislation covering research and development.
