Medicines/finished pharmaceutical products

Reference Number: 
TB311

Date of prequalification: 
22 February 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Moxifloxacin (hydrochloride)
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 400mg
Storage condition: 
Do not store above 30°C, protect from moisture, protect from light
Shelf life (months): 
36
Packaging: 
Blister Alu/Alu 5x1
Applicant: 
Getz Pharma Pvt Ltd, 29-30/27 Korangi Industrial Area, Karachi, 74900
FPP Manufacturing Site: 

Getz Pharma Pvt Ltd, 29-30/27 Korangi Industrial Area, Karachi, 74900

API Manufacturing Site: 

(Moxifloxacin (hydrochloride)) Hetero Drugs Ltd, Unit 1, Survey No 213, 214 & 255, Bonthapally Village, Jinnaram Mandal,Medak District, Telangana, India

API WHO Public Inspection Reports: