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TB259

WHO Product ID
TB259
Status
Prequalified
INN, dosage form and strength
Rifampicin Capsules, hard 150mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
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
Shelf life (months)
24
Packaging Type
Bottle, HDPE
Configuration
Self Sealing LDPE Bag in plain Triple Laminated (LDPE/AL/PET) Sachet packed in Bottle, HDPE, 100x1
Shelf life (months)
24
API Manufacturing Site(s)
By Organization
By Active Ingredient
Lupin Ltd.
T-142, M.I.D.C, Thane District
Tarapur, Via Boisar,
Maharashtra
401 506
India
Rifampicin
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
India
Rifampicin
Macleods Pharmaceuticals Ltd
Plot No D-3/27 GIDC, Dahej-III
Village Sambheti, District Bharuch,
Gujarat
392130
India
Rifampicin
Olon Active Pharmaceutical Ingredients India Private Limited
Plot No: L-1, L-21 to L-28 & L-44, Additional Phase MIDC, Raigad District
Mahad,
Maharashtra
402 301
India
Rifampicin
Shenyang Antibiotic Manufacturer (Suspended)
Jianshebei 3 Road, Hushitai Town, Xinchengzi District
Shenyang,
Liaoning
110 122
China
Rifampicin
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Unit 2, Phase II, III and IV, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India

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