Do you hold GMP certificates for you APIs?

Yes

 

 

Are you manufacturing sites ISO certified?

Budapest

OHSAS 18001:2007

ISO 50001:2011

ISO 14000:2015

 

Copenhagen

ISO 14001:2015 & DS/OHSAS 18001:2008

 

Taizhou

ISO 14001:2004 & OHSAS 18001:2007

 

 

Are you inspected by the FDA?

Yes.

 

 

When was your last FDA inspection?

Budapest: 2015, February

Raleigh: CBER: 2019, October

Copenhagen: 2018, April

Taizhou: 2018, April

 

 

 

Are you inspected by local authorities?

Yes

Copenhagen: Danish Medicines Agency

Budapest: National Institute of Pharmacy

Taizhou: China Food and Drug Administration

Raleigh: FDA

 

 

For which APIs do you have CEP
(Certificate of Sustainability)?

Amphotericin B, Bacitracin, Bacitracin Zinc, Conlistin Sulphate, Colistimethate Sodium, Gramicidin, Polymyxin B Sulphate, Tyrothricin, Vancomycin Hydrochloride

 

 

Do you have a Quality Manual?

Yes

 

 

How do you convert from

KgActivity to Kg (weight)?

1000gActivity/potency = kg

 

 

Do you follow ICH Q7

Yes

FAQ for customers