H&T Presspart, the global market leader in respiratory drug delivery components, has reached a major milestone of 30 years for our Pharmaceutical Aerosol Canister Drug Master File (DMF) filed with the US FDA.

Our very first DMF for pharmaceutical aerosol cans (DMF number 7407) was first registered with the US FDA on the 22nd March 1988. That may not seem like so long ago but to put that in to perspective, when the DMF was first filed in 1988, H&T Presspart’s regulatory affairs specialist who is responsible for managing our DMFs was only 3 years old.

In fact, in 1988 the internet didn’t even exist, and now from the 5th May 2018 all DMF’s for the U.S.A have to be submitted electronically via the eCTD portal.

The H&T Presspart DMF holds all of the information on our aluminium metered-dose inhaler (MDI’s) canisters, for any of our customers who are currently, or wish to sell, metered-dose inhalers in the U.S marketplace. Since our DMF was submitted in 1988, there have been over 130 Letters of Authorisation (LOA’s) issued to our customers to support their drug applications

As well as our manufacturing expertise in metered-dose inhaler cans, H&T Presspart offers our customers full regulatory support for their MDI products, another reason why we are the partner of choice for any company wishing to sell MDI’s into the U.S.A.

metered-dose inhaler canister
H&T Presspart’s range of metered-dose inhaler canisters.