WHO Product ID
MA194
Status
Prequalified
INN, dosage form and strength
Artesunate Powder for solution for injection 120mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Powder for solution for injection
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Vial, type III glass, 15 mL + Ampoules, type I glass, 1 mL + Ampoules, type I glass, 5 mL
Configuration
(Artesunate powder 120mg + 1mL Sodium bicarbonate solution x 2+ 5mL Sodium chloride solution x 2) x1; (Artesunate powder 120mg + 1mL Sodium bicarbonate solution x 2+ 5mL Sodium chloride solution x 2) x100
Shelf life (months)
36
Storage conditions
Do not store above 25°C. Keep the vial and ampoules in the provided carton to protect the product from light. Do not refrigerate or freeze.
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mangalam Drugs and Organics Limited
Unit 1, Plot No 187, 2nd Phase, GIDC
Vapi, Valsad,
Gujarat
396 195
India
Artesunate
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Artesunate
FPP Manufacturing Site(s)
Immacule Lifesciences Pvt Limited (Diluent/solvent manufacturer only)
Ropar Road, Village Thanthewal,, Dist.-. Solan
Nalagarh,
Himachal Pradesh
174101
India
Macleods Pharmaceuticals Ltd
Unit 2, Phase I, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India
Sovereign Pharma PVT. Ltd. (Diluent/solvent manufacturer only)
Survey No. 46/1-4, Village Kadaiya
Daman,
396210
India
