Product Details
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 Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
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
Mylan Laboratories Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Delamanid
Otsuka Pharmaceutical Co. Ltd
Second Tokushima Factory 224-18, Hiraishi, Ebisuno, Kawauchi-cho, Tokushima-shi
Tokushima,
771-0182
Japan
Delamanid
FPP Manufacturing Site(s)
Fuji Chemical Industries Co., Ltd
1 Gohkakizawa, Kamiichi-machi, Nakaniikawa-gun
Toyama,
930-0397
Japan
Mylan Laboratories Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Mylan Laboratories Ltd
F4 & F12 Malegaon MIDC, Nashik District
Sinnar,
Maharashtra
422 113
India