Medicines/finished pharmaceutical products

Reference Number: 
HA738 (a)

Date of prequalification: 
11 June 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ciprofloxacin (hydrochloride)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 500mg
Storage condition: 
Do not store above 25°C
Shelf life (months): 
48
Packaging: 
Bottle, HDPE 50x1, 100x1, 500x1
Applicant: 
Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd), Mumbai, 400030, India
FPP Manufacturing Site: 

Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd), Plot No. 215-219, GIDC Industrial area, Bharuch, Gujarat, 394116, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Ciprofloxacin (hydrochloride)) Neuland Laboratories Limited, Plot Nos: 92, 93, 94, 257, 258, 259, IDA, Pashamylaram, Isnapur,, Medak District, Telangana, 502319, India

API WHO Public Inspection Reports: