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Commitment to Top-Standard Quality

KinBio’s commitment to top-standard quality is inherent across the entire global organization, from our FDA-approved cGMP sites to our state-of-the-art research and development laboratories in pursuit of life-changing and life-saving medications.

KinBio is routinely inspected by the Israeli Ministry of Health (IMOH), which is recognized by the EMA. The European Union (EU) has an agreement on conformity assessment and acceptance of industrial products in place with Israel. This agreement recognizes Israel’s industrial standards as being equivalent to European standards. It covers products for human and veterinary use (medicinal products, active pharmaceutical ingredients, and excipients) and procedures related to good manufacturing practice (GMP).

The agreement means that Israel and the EU recognize each other’s:

  • GMP inspection conclusions;
  • manufacturing and import authorizations;
  • certification of conformity of batches, without the need for re-testing at import;
  • official-control-authority batch release (OCABR).