Medicines/finished pharmaceutical products

Reference Number: 
TB304

Date of prequalification: 
12 December 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Cycloserine
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Capsules, hard 250mg
Storage condition: 
Do not store above 25°C. Protect from moisture. Discard the product 30 days after initial opening
Shelf life (months): 
24
Packaging: 
Bottle HDPE 100x1; Blister Alu/Alu 10x1, 10x10
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 H-12 & H13 MIDC Waluj Industrial Area, Aurangabad, Maharashtra, 431 136, India

API Manufacturing Site: 

(Cycloserine) Strides Shasun Ltd, A-1/B Sipcot Industrial Complex, Kudikadu Village, Cuddalore, Tamil Nadu, 607 005, India