Medicines/finished pharmaceutical products

Reference Number: 
TB156

Date of prequalification: 
14 December 2009
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Para-aminosalicylate (sodium)
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Granules, Gastro-resistant 60g/100g
Storage condition: 
Do not store above 25°C, store in dry condition, protect from light
Shelf life (months): 
36
Packaging: 
Bottle HDPE/Sachet Alu/PET/Alu/LLDPE: 100gx1; Sachet Alu/PET/Alu/LLDPE: 9.2gx30
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Macleods Pharmaceuticals Ltd, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 210, India
Macleods Pharmaceuticals Ltd, Block No. N2, Village Theda, P.O. Lodhi Majra, Tehsil Baddi, District Solan, Himachal Pradesh, 174 101, India

API Manufacturing Site: 

(Para-aminosalicylic acid) Biochemical & Synthetic Products Ltd, Synthetic Section - Unit 1, Plot No 11/6/2029, Phase 2, Sri Venkateshwara Cooperative, Industrial Estate, Balanagar, Hyderabad, Medak District, Andhra Pradesh, 500 037, India
(Para-aminosalicylate (sodium)) Macleods Pharmaceuticals Ltd, Plot No 2209 GIDC Industrial Area, At and Post Sarigam, Taluka: Umbergeon, Valsad District, Gujarat, 396 155, India