Medicines/finished pharmaceutical products

Reference Number: 
HA681

Date of prequalification: 
15 August 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Efavirenz
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 600mg
Storage condition: 
Do not store above 30°C, store in dry condition, protect from light
Shelf life (months): 
24
Packaging: 
Bottle,HDPE 30x1
Applicant: 
Government Pharmaceutical Organization (GPO), 75/1 Rama VI Road, Ratchathewi, Bangkok, 10400, Thailand
FPP Manufacturing Site: 

The Government Pharmaceutical Organization (GPO), Rangsit Pharmaceutical Production Plant 1, 138 Moo 4, Rangsit-Nakhonnayok Road, Bueng Sanan, Thanyaburi, Pathumthani, 12110, Thailand

API Manufacturing Site: 

(Efavirenz) Mylan Laboratories Ltd, Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535 204, India
(Efavirenz) Mylan Laboratories Limited (Unit-10), Plot No. 86, Ramky Pharma City (India) Ltd, JN Pharma City, Parawada Mandal, Visakhapatnam, Andhra Pradesh, 531019, India