Medicines/finished pharmaceutical products

Reference Number: 
MA123

Date of prequalification: 
19 June 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artesunate
Therapeutic area: 
Malaria
Dosage form & strength: 
Capsule, Soft, Rectal 100mg
Storage condition: 
Do store above 25°C, excursions permitted to 15°C and 30°C. Avoid excursions over 30°C. Do not freeze
Shelf life (months): 
24
Packaging: 
Blister; Alu/Alu 2x1
Applicant: 
Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore
FPP Manufacturing Site: 

Strides Pharma Science Limited, Oral Solid Dosage Forms Division, KRS Gardens, 36/7, Suragajakkanahalli, Indlawadi Cross, Anekal Taluk, Bangalore, Karnataka, 562 106, India

API Manufacturing Site: 

(Artesunate) Solara Active Pharma Sciences Ltd, 120 A & B, 36, 120P & 121 Industrial Area, Baikampady, New Mangalore, Karnataka, 575 011, India