Medichem launches Award in Organic Chemistry.

We are proud to announce that Medichem Manufacturing (Malta) Ltd. has been one of sponsors of this year’s annual National Chemistry Symposium, organised by the Department of Chemistry at the University of Malta and S-Cubed, the Science Students’ Society. During this event we launched the first edition of the Medichem Award in Organic Chemistry. This cash award has been set up to recognise outstanding achievements in organic chemistry by students in the B.Sc. (Hons.) programme. The recipient of the first edition is Roderick Abdilla.

Chemistry

FDA inspection in Celrà (Spain) with no “Form 483” for the sixth consecutive time

The latest US FDA inspection of our plant in Celrà (Girona), Spain in April resulted in no “Form 483” (no observations were noted). For the Celrà site this was the sixth consecutive FDA inspection without any observation.

 

The inspection was carried out by an FDA investigator from April 27th to April 30th, 2015 and covered Good Manufacturing Practice (cGMP) as well as several Active Pharmaceutical Ingredients (APIs) exported to the US.

Malta site FDA inspection in February this year was also a no ‘Form 483’ one for the second consecutive time.

 

This is an excellent record particularly because this is Medichem’s eighth FDA inspection without any observation and the second consecutive time that our two plants pass an FDA inspection without any observation in the same year.

FDA inspection in Hal Far (Malta) with no “Form 483” for the second consecutive time

Medichem Malta plant passed a US FDA inspection for the second consecutive time without receiving any observation.

The inspection of Medichem’s plant in Hal Far (Malta) was carried out by two FDA officers from the 16th to the 19th of February 2015 and covered Good Manufacturing Practice (GMP) systems, as well as several Active Pharmaceutical Ingredients (APIs) exported to the US.

Start operations of High Potency API plant in Malta

In May 2014, Medichem opened a brand new High Potency API unit (HPAPI) in its Maltese plant, located in Hal Far. The HPAPI modular laboratory is a multipurpose facility that is fully equipped for the synthesis of HPAPIs from the very early R&D phases, through process development and to manufacturing allowing Medichem to produce Class 4 HPAPIs with OEL down to 40 ng/m3 within current Good Manufacturing Practices (cGMP) and FDA inspected environments.

FDA inspection in Celrà (Spain) with no “Form 483” for the fifth consecutive time

The latest FDA inspection of our plant in Celrà (Girona), Spain in September resulted in no “Form 483” (no observations were noted).

The inspection was carried out by an FDA investigator and covered cGMP and preapproval for several products.

For the Celrà site this was the fifth consecutive FDA inspection without any observation. Malta site inspection earlier this year was also a no ‘Form 483’ one. This is an excellent record particularly in the year of the 40th anniversary of the foundation of the company.