Medicines/finished pharmaceutical products

Reference Number: 
TB324

Date of prequalification: 
26 September 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Protionamide
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 250mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister: Alu/PVC 10x1, 10x10; Bottle: HDPE 60x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, Pithampur, District Dhar, Madya Pradesh, 454 775, India

API Manufacturing Site: 

(Protionamide) Mylan Laboratories Ltd (Unit 7), Plot No.14, 99 & 100 IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District, Telangana, 502 307, India

API WHO Public Inspection Reports: