Medicines/finished pharmaceutical products

Reference Number: 
MA124

Date of prequalification: 
22 February 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artesunate
Therapeutic area: 
Malaria
Dosage form & strength: 
Capsule, Soft, Rectal 100mg
Storage condition: 
Do not store above 25°C. Do not freeze or refrigerate. Avoid excursions above 30°C
Shelf life (months): 
24
Packaging: 
Blister; Alu/Alu 2x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd., Plot D-7 (Unit1), MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Artesunate) Cipla Ltd, Unit 1, Plot A-33 & A-2 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
(Artesunate) Cipla Ltd, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India