Adding Value

Regulatory affairs and quality

Tailor-made solutions

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.

Long-standing expertise
at your service

+ 0

Marketing

authorizations

0

DMFs

0

Active ANDAs

with our APIs

0

Certificates

of suitability

0

FDF ANDAs

submitted

…submitted to date to Regulatory Agencies around the globe.

API Celrà.
España

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

API+FDF
Hal Far. Malta

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)