The FDA had registered INJEX Pharma, Berlin, and INJEX Pharma US, Miami, and issued approval for the import and sale of INJEX 30 in the US market.
The condition was the registration by the FDA for INJEX Pharma GmbH as manufacturer and exporter. The registration is now finalized, based on the FDA 510(K) for the INJEX system under Rösch Medizintechnik.
INJEX Pharma GmbH is the new registered manufacturer and exporter.
INJEX Pharma USA president Sylwin Grinman said, "This needle free injection system will create remarkable changes for all people.
Its applications are numerous and constantly emerging in areas of dentistry."