GP Pharm Obtains Approval for GCC Countries

Last January, GCC-DR (Gulf Central Committee for Drug Registration) granted a Registration Certificate of Manufacturing Site to GP Pharm.

This certificate is valid for the next five years, allowing GP Pharm to manufacture drug products for the region. The GCC-DR certificate covers authorisation in Saudi Arabia, Kuwait, Bahrain, Qatar, the United Arab Emirates, and the Sultanate of Oman.

GP Pharm owns a state-of-the-art manufacturing site located in Sant Quintí de Mediona (Barcelona, Spain) on 30,000m² of land. At this site GP Pharm has the capability to produce drug products for injection using cytotoxic and high potency products. Additionally, GP Pharm produces at industrial-scale drug delivery formulations for injection such liposomes and microspheres.

This approval complements other currently valid manufacturing authorisations (GMP):

  • AEMPS (Spanish Health Agency) – Europe [2006]
  • PMDA – Japan [2008]
  • TGA – Australia [2009]
  • PHAC – Canada [2010]

The next step for the company consists of obtaining authorisation by the FDA. During 2011 GP Pharm plans to apply for its first FDA inspection, which would allow the company to enter the US market with products manufactured at its site.

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