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TB297

WHO Product ID
TB297
Status
Prequalified
INN, dosage form and strength
Linezolid Tablet, Film-coated 600mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Strip, Alu/Alu
Configuration
10x10, 4x5, 10x2
Shelf life (months)
60
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
Packaging Type
Blister, Alu/PVC
Configuration
10x10; 21x5;7x10
Shelf life (months)
60
Storage conditions
Do not store above 30°C, store in dry condition, protect from light
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
Linezolid
Optimus Drugs Pvt Ltd
Unit I, Survey No 239 and 240, Dothigudem, Pochampally (M), Yadadri-Bhuvanagiri (D)
Telangana
508 284
India
Linezolid
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
FPP Packaging Only
Oxalis Labs
Vill. Theda, Baddi, Distt. Solan
P.O.lodhimajra,
174101
India

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