FAQ for Customers
Do you hold GMP certificates for your APIs?
Yes
Are your manufacturing sites ISO certified?
We hold an ISO 14001 certification (environmental certification)
| |
Are you inspected by the FDA?
Yes
When was the last FDA inspection?
Budapest: September 2005
Copenhagen: February 2010
Oslo: June 2008
Taizhou: February 2009
Are you inspected by local authorities?
Yes
Copenhagen: Danish Medicine Agency
Budapest: National Institute of Pharmacy
Oslo: Norwegian Medicine Agency
For which APIs do you have a CEP (Certificate of Suitability)?
Vancomycin Hydrochloride, Polymyxin B sulphate, Amphotericin B,
Colistin Sulphate, Colistimethate sodium, Gramicidin, Bacitracin,
Bacitracin Zinc (non-sterile)
Do you have a Quality Manual?
Yes
Do you manufacture Penicilline/ß-lactames?
No
How do you convert from KgActivity to Kg (weight)?
1000gActivity/Potency = kg
Do you follow ICH Q7?
Yes
