Medicines/finished pharmaceutical products

Reference Number: 
TB224

Date of prequalification: 
22 December 2011
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ofloxacin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 200mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 100x1, 500x1, 1000x1; Blister Alu/PVC: 10x10
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India

API Manufacturing Site: 

(Ofloxacin) Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd, 333 Jiangnan Road, Hengdian, Dongyang, Zhejiang Province, 322 118, China (People's Republic of)

API WHO Public Inspection Reports: