Medicines/finished pharmaceutical products

Reference Number: 
TB306

Date of prequalification: 
30 June 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. Avoid excursions above 30°C. Protect from light and moisture
Shelf life (months): 
24 Months
Packaging: 
Bottle HDPE 40x1; Blister Alu/Alu 10x10
Applicant: 
Strides Pharma Science Limited, 3rd & 4th Floor, The Batra Centre, No. 28, Sardar Patel Road, Guindy, Chennai, Tamil Nadu, 600032, India
FPP Manufacturing Site: 

Strides Pharma Science Limited, Unit II, RS No 32-34, PIMS Road, Periyakalapet, Puducherry, 605 014, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Cycloserine) Solara Active Pharma Sciences Ltd, A-1/B Sipcot Industrial Complex, Kudikadu Village, Cuddalore, Tamil Nadu, 607 005, India