Medicines/finished pharmaceutical products

Reference Number: 
TB228

Date of prequalification: 
18 December 2015
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, protect from light
Shelf life (months): 
24
Packaging: 
Bottle;HDPE 40x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit 4, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette, Goa, 403 722, India
Cipla Ltd, Unit 7, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette, Goa, 403 722, India

API Manufacturing Site: 

(Cycloserine) ST Pharm Co. Ltd, Banwol Site 2, 171, Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15610, Republic of Korea
(Cycloserine) Strides Shasun Ltd, A-1/B Sipcot Industrial Complex, Kudikadu Village, Cuddalore, Tamil Nadu, 607 005, India