Medicines/finished pharmaceutical products

Reference Number: 
MA135

Date of prequalification: 
18 December 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artesunate + Sodium Bicarbonate + Sodium Chloride
Therapeutic area: 
Malaria
Dosage form & strength: 
Powder, solvent and diluent for solution for injection 60mg + 5%w/v + 0.9%w/v
Storage condition: 
Store below 30°C. Keep the vial and ampoules in the provided carton to protect the product from light. Do not refrigerate or freeze. Avoid excursions above 30°C
Shelf life (months): 
24
Packaging: 
Vial, USP Type I glass 1x1, 1ml of sodium bicarbonate 5% w/v, ampoule: 5ml of sodium chloride 0.9% w/v, ampoule
Applicant: 
Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India
FPP Manufacturing Site: 

Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India

API Manufacturing Site: 

(Artesunate - Sterile) Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India