INJEX Pharma AG receives FDA clearance for the import and sale of the needle free injection technology INJEX 30 into the US Market
The FDA had registered INJEX Pharma GmbH, Berlin, and INJEX Pharma US, Miami, and given 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. This registration is now finalized.
The FDA 510(K) registration is based on the FDA 510(K) for the INJEX system under Rösch Medizintechnik AG. INJEX Pharma GmbH is the new registered manufacturer and exporter. The FDA 510(K) by Rösch AG was still valid, but had to be reactivated by the new manufacturer. An important milestone for INJEX Pharma AG began as a new startup company with worldwide sales and marketing at the end of February 2012.
The management of the company will go on a road show in New York next week and will present the new concept for worldwide sales and marketing to investment groups on Wall Street. About 20 presentations are scheduled right now.
According to Sylwin Grinman, President of INJEX Pharma USA:
“USA/North America is a powerful market for any new and unique technology that wants to establish itself in its respective market place. This needle free injection system will create remarkable changes for all people.
Its applications are numerous and constantly emerging in areas of dentistry, diabetes, cosmetic & beauty care, vaccines, ED dysfunction.
We have developed a new concept in the beauty & cosmetic industry with our new line of Shireen, which will be used in wrinkle treatments. Shireen will revolutionize the cosmetic market.
INJEX the needle free injection system is now a global commodity and it is the beginning of a new era in medical device technology. It is simple, easy to use and will fit perfectly into the American lifestyle.”
Source: INJEX Pharma USA
