Product Details
WHO Product ID
ANDA 078958 USFDA
Status
Prequalified
INN, dosage form and strength
Efavirenz Tablet 600mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Emcure Pharmaceuticals Ltd
Emcure House, T-184, M.I.D.C., Bhosari, Pune
411026
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 60x1
Shelf life (months)
24
Packaging Type
Blister, Al/PVC
Configuration
10x3
Shelf life (months)
24
FPP Manufacturing Site(s)
Emcure Pharmaceuticals Ltd
Plot No. P-1 & P-2, I.T.B.T. Park, Phase II, MIDC, Hinjawadi
Pune,
Maharashtra
411057
India