Product Details
WHO Product ID
TB230
Status
Prequalified
INN, dosage form and strength
Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
5x1, 20x1, 7x10, 10x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/PVC
Configuration
10x10
Shelf life (months)
60
Storage conditions
Do not store above 30°C, store in dry condition, protect from light
Packaging Type
Strip, Alu/Alu
Configuration
5x1, 20x1, 7x10, 10x10
Shelf life (months)
48
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
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)
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
India
Moxifloxacin (hydrochloride)
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Block No. N2, Village Theda, P.O. Lodhi Majra, District Solan
Tehsil Baddi,
Himachal Pradesh
174 101
India
Macleods Pharmaceuticals Ltd
Unit 2, Phase II, III and IV, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India