Medicines/finished pharmaceutical products

Reference Number: 
RH073 (a)

Date of prequalification: 
12 December 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Magnesium sulfate
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Solution for injection 50% w/v, 2ml
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Ampoule, Neutral type I glass 2mlx10
Applicant: 
Aurum Pharmaceuticals Ltd , Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom
FPP Manufacturing Site: 

Macarthys Laboratories Limited, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Magnesium sulfate) K+S KALI GmbH, Werk Werra, Hattorfer Strasse, 36269, Philippsthal (Werra),Germany
(Magnesium sulfate heptahydrate) Macco Organiques, S.R.O, Zahradni 1938/46c, Bruntál, 792 01, Czech Republic

API WHO Public Inspection Reports: