Medicines/finished pharmaceutical products

Reference Number: 
HA334 (a)

Date of prequalification: 
23 May 2006
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Indinavir (sulfate)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Capsules, hard 400mg
Storage condition: 
Do not store above 30°C, protect from moisture
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 90x1, 180x1
Applicant: 
Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands
FPP Manufacturing Site: 

Merck Sharp & Dohme Corp., 4633 Merck Road, Wilson, NC 27893, United States of America
Patheon Pharmaceuticals Inc., 2110 East Galbraith Road, Cincinnati, OH 45237-1625, United States of America
Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Indinavir) Merck Sharp & Dohme Corp, PO Box 2000, 126 E. Lincoln Avenue, Rahway, New Jersey, NJ 07065-0900, United States of America
(Indinavir) Merck and Co. Manufacturing Division, 2778 South East Side Highway, Elkton, Virginia, United States of America
(Indinavir) Merck Sharp & Dohme Corp., Flint River Plant, 3517 Radium Springs Road, Albany, GA 31705, United States of America

API WHO Public Inspection Reports: