WHO Product ID
TB388
Status
Prequalified
INN, dosage form and strength
Delamanid Tablet, Film-coated 50mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Mylan Laboratories Ltd.
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu, CF O2 1.16%
Configuration
8x6
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
Packaging Type
Blister, Alu/Alu, CF O2 3-5%
Configuration
8x6
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
API Manufacturing Site(s)
By Organization
By Active Ingredient
Tianish Laboratories Private Limited
Unit 8, G. Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Delamanid
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
F4 & F12 Malegaon MIDC, Nashik District
Sinnar,
Maharashtra
422 113
India
Tianish Laboratories Private Limited
Unit 8, G. Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
