Medicines/finished pharmaceutical products

Reference Number: 
NT004

Date of prequalification: 
05 September 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Praziquantel
Therapeutic area: 
Neglected Tropical Diseases (NTD)
Dosage form & strength: 
Tablet, Film-coated 600mg
Storage condition: 
Do not store above 30°C, store in dry condition, protect from light
Shelf life (months): 
36
Packaging: 
Blister,Alu/PVC-PVdC 10x9; Container,HDPE 100x1;500x1
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Macleods Pharmaceuticals Ltd, Block No. N2, Village Theda, P.O. Lodhi Majra, Tehsil Baddi, District Solan, Himachal Pradesh, 174 101, India

API Manufacturing Site: 

Jiangsu Chengxin Pharmaceutical Co Ltd, No.338, Shanghai Road, Binjiang Pharm-Chem Industry Park, Qidong, Jiangsu, 226221, China (People's Republic of)
(Praziquantel) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)