Medicines/finished pharmaceutical products

Reference Number: 
TB326

Date of prequalification: 
22 February 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Levofloxacin
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): 
36
Packaging: 
Strip;Alu/Alu 10x10; 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: 

(Levofloxacin) Macleods Pharmaceuticals Ltd, Plot No 2209 GIDC Industrial Area, At and Post Sarigam, Taluka: Umbergaon, Valsad District, Gujarat, 396 155, India
(Levofloxacin) Zhejiang Langhua Pharmaceutical Co Ltd, No 7, Donghai 3rd Avenue, Zhejiang Provincial Chemical & Medical Materials Base Linhai Zone, Linhai City, Zhejiang Province, 317 016, China (People's Republic of)
(Levofloxacin) Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd, 333 Jiangnan Road, Hengdian, Dongyang, Zhejiang Province, 322 118, China (People's Republic of)