Product Details
WHO Product ID
TB315
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
Hetero Labs Ltd
Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Ranga Reddy District
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
10x1, 10x10
Shelf life (months)
48
Storage conditions
Do not store above 30°C, store in the original container, protect from light
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)
FPP Manufacturing Site(s)
Hetero Labs Ltd
Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District
Telangana
509 301
India