Medicines/finished pharmaceutical products

Reference Number: 
NT002

Date of prequalification: 
20 August 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Diethylcarbamazine (citrate)
Therapeutic area: 
Neglected Tropical Diseases (NTD)
Dosage form & strength: 
Tablet 100mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
60
Packaging: 
Bottle HDPE: 1000x1
Applicant: 
Eisai Co Ltd, 4-6-10 Koishikawa, Bunkyo-Ku, Tokyo, 112-8088, Japan
FPP Manufacturing Site: 

Eisai Pharmatechnology and Manufacturing Pvt Ltd, Plot No 96, 97, 98, 124 & 126 Ramky Pharma City (SEZ), Parawada, Visakhapatnam District, Andhra Pradesh, 531 019, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Diethylcarbamazine (citrate)) Saurav Chemicals Ltd, Barwala Road, Village Bhagwanpura, Dera bassi, Ajitgarh/SAS Nagar (Mohali), Punjab, 140 507, India
(Diethylcarbamazine (citrate)) SAFC Sigma-Aldrich Ireland Ltd, Arklow, Wicklow, Republic of Ireland