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TB390

WHO Product ID
TB390
Status
Prequalified
INN, dosage form and strength
Bedaquiline fumarate Tablet 100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
188x1
Shelf life (months)
48
Storage conditions
Do not store above 30°C. Store in the original container or package in order to
Packaging Type
Blister, Alu/PVC/Alu
Configuration
6x12, 10x10, 28x7
Shelf life (months)
48
Storage conditions
Do not store above 30°C. Store in the original container or package in order to
API Manufacturing Site(s)
By Organization
By Active Ingredient
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
India
Bedaquiline fumarate
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Block No. N2, Village Theda, P.O. Lodhi Majra, District Solan
Tehsil Baddi,
Himachal Pradesh
174 101
India

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