Product Details
WHO Product ID
TB349
Status
Prequalified
INN, dosage form and strength
Moxifloxacin (hydrochloride) Tablet, Dispersible 100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Applicant organization
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PE/PVdC
Configuration
10x10, 10x14
Shelf life (months)
48
Storage conditions
Do not store above 30°C. Avoid excursions above 30°C. Protect from light and moi
Packaging Type
Strip, Alu/Alu
Configuration
10x10
Shelf life (months)
48
Storage conditions
Do not store above 30°C. Avoid excursions above 30°C. Protect from light and moi
API Manufacturing Site(s)
By Organization
By Active Ingredient
Aragen Life Sciences Limited
Manufacturing unit-1 Plot 28-A IDA Nacharam Medchal-Malkajgiri
Hyderabad,
Telangana
500076
India
Moxifloxacin (hydrochloride)
Chromo Laboratories India Private Limited
Plot No. 43 & 44, Phase II, I.D.A, Pashamylaram, Patancheru Mandai, Sangareddy District
Telangana
502 307
India
Moxifloxacin (hydrochloride)
MSN Pharmachem Pvt Ltd
Plot No 212, A, B, C, D, Phase II, I.D.A Pashamylaram Village, Sangareddy District
Patancheru Mandal,
Telangana
502 307
India
Moxifloxacin (hydrochloride)
FPP Manufacturing Site(s)
Micro Labs Limited
Unit 3, 92 Sipcot Industrial Complex
Hosur,
Tamil Nadu
635 126
India
Micro Labs Limited
ML08, Plot No 15/A, 2nd Phase, Kumbalgodu Industrial Area
Bangalore,
560 074
India