Product details
WHO Product ID
WHOAPI-327
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Hepatitis B and C
Type
None
Grade
Standard
INN
Daclatasvir (dihydrochloride)
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/DAY/AP/001/02, May 2021
MLL/DAY/RP/001/02, May 2021
MLL/DAY/AP/001/02, May 2021/Amend 01 - November-2023
MLL/DAY/RP/001/02, May 2021/Amend 01 - November-2023
MLL/DAY/RP/001/02, May 2021
MLL/DAY/AP/001/02, May 2021/Amend 01 - November-2023
MLL/DAY/RP/001/02, May 2021/Amend 01 - November-2023
Product Grades
API specification number
STP/FPR/DAY/001/05
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
White polyethylene bag (LDPE), which is placed in a black LDPE bag, with one molecular sieve and one silica gel sachet. Both bags are placed in triple laminated aluminium bag and 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