Product details
WHO Product ID
WHOAPI-353
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Hepatitis B and C
Type
None
Grade
Standard
INN
Velpatasvir
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/VEN/AP/003/02, Aug 2021
MLL/VEN/RP/003/02, Aug 2021
MLL/VEN/AP/003/02, Aug 2021/ Amend 01, December-2022
MLL/VEN/RP/003/02, Aug 2021/ Amend 01, December-2022
MLL/VEN/RP/003/02, Aug 2021
MLL/VEN/AP/003/02, Aug 2021/ Amend 01, December-2022
MLL/VEN/RP/003/02, Aug 2021/ Amend 01, December-2022
Product Grades
API specification number
STP/FPR/VEN/001/08
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
48
Duration type
Retest period
Packaging
White LDPE bag under nitrogen, which is placed in a black LDPE bag, with one silica gel and one molecular sieve and heat sealed. Both bags are placed into an outer bag of triple laminated aluminium bag and heat sealed. These bags are packed in HDPE drums.
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India