Product details
WHO Product ID
WHOAPI-444
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Standard
INN
Delamanid
Confirmation of WHO API prequalification document (version date)
Applicant organization
Tianish Laboratories Private Limited
Plot No. 564/A/22, Road No. 92, Jubilee Hills, Filmnagar, Shaikpet
Hyderabad,
Telangana
500096
India
APIMF Version Number
MLL/DEM/AP/001/01, March 2024
MLL/DEM/RP/001/01, March 2024
MLL/DEM/RP/001/01, March 2024
Product Grades
API specification number
STP/ FPR/DEM/001/05
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Packed in antistatic white polyethylene bags (LDPE), twist and tied. It is then inserted in antistatic white polyethylene bags (HMLDPE), heat sealed. These bags are further packed in HDPE drums and tightly closed with plastic lid having rubber gasket followed by locking ring, seal and labeled.
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India