Simvastatin is manufactured at Hovione PharmaScience Ltd.
facilities located in Macau (South China) at the following address:
Hovione PharmaScience Ltd.
Estrada Coronel Mesquita
Taipa
MACAU
Telephone + (853) 82 75 44
Telefax + (853) 82 77 14
Hovione PharmaScience was first inspected by the FDA in 1987 and
has been successfully inspected regularly ever since.
The last inspection occurred in February 2000 and FDA considered
that Hovione facilities comply with the cGMPs.
 This
manufacturing site is ISO 9001 certified. The quality system follows
the current Good Manufacturing Practices for Active Pharmaceutical
Ingredients guideline of ICH and CFR regulations.
The Quality system is under continuous improvement to comply with
the most stringent regulatory requirements and to provide a better
service to our customers.
To view the FDA letter accepting
Hovione PharmaScience facility to manufacture the product covered in
the latest FDA inspection (please
click here). |
