Medicines/finished pharmaceutical products

Reference Number: 
HA613

Date of prequalification: 
04 June 2015
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Fluconazole
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet 200mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Bottle;HDPE 30x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, Plot No H-12 & H13 MIDC Waluj Industrial Area, Aurangabad, Maharashtra, 431 136, India

API Manufacturing Site: 

(Fluconazole) Mylan Laboratories Ltd (Unit 7), Plot No.14, 99 & 100 IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District, Telangana, 502 307, India

API WHO Public Inspection Reports: