The strategic planning and location in Malta of Medichem and Combino Pharm allow the launch of our products to the market from the first day after the expiration date of the patent.
Being the first to launch is key to achieving optimal market penetration.
As your business partner, we know that being first to launch is key to achieving optimal market penetration for this reason we offer tailor-made solutions in contract services to maximize your portfolio and sales.
Marketing
authorizations
DMFs
Active ANDAs
with our APIs
Certificates
of suitability
FDF ANDAs
submitted
…submitted to date to Regulatory Agencies around the globe.
Spanish Medicines Agency
(AEMPS) since 2008
Catalunya GMP plant inspection since 2014
R&D hubs in Barcelona and Celrà (Spain) since 2018
ISO 14001 certified
since 2001
FDA inspected since 1985
No form 483 since 1999
Korean FDA
(MFDS) since 2012
PMDA approved plants
since 2009
Halal Inspection
since 2016
US FDA inspected since 2007
(API), since 2017 (FDF)
No form 483 since 2012 (API)
EU GMP certification by Malta
Medicines Authority since 2007
(API) since 2006 (FDF)
ISO 14001 certified
since 2009 (API)