Medicines/finished pharmaceutical products

Reference Number: 
TB342

Date of prequalification: 
18 December 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Moxifloxacin (hydrochloride)
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Dispersible 100mg
Storage condition: 
Do not store above 30°C, store in dry condition, protect from light
Shelf life (months): 
24
Packaging: 
Blister, Alu/Alu 10x10
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Macleods Pharmaceuticals Ltd, Block No. N2, Village Theda, P.O. Lodhi Majra, Tehsil Baddi, District Solan, Himachal Pradesh, 174 101, India

API Manufacturing Site: 

(Moxifloxacin (hydrochloride)) MSN Pharmachem Pvt Ltd, Plot No 212, A, B, C, D, IDA Phase II, Pashamylaram, Patancheru (M), Medak District, 502 307, India
(Moxifloxacin (hydrochloride)) Macleods Pharmaceuticals Ltd, Plot No 2209 GIDC Industrial Area, At and Post Sarigam, Taluka: Umbergaon, Valsad District, Gujarat, 396 155, India