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
Matrix Pharmacorp Private Limited
Plot No. 14, 99 and 100, IDA Pashamylaram Phase-II
Patancheru, Sangareddy District,
Telangana
502307
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/AP/001/02, May 2021/Amend 02, June 2024
MLL/DAY/RP/001/02, May 2021/Amend 02, June 2024
MLL/DAY/AP/001/02, May 2021/Amend 03 - September 2025
MLL/DAY/RP/001/02, May 2021/Amend 03 - September 2025
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/AP/001/02, May 2021/Amend 02, June 2024
MLL/DAY/RP/001/02, May 2021/Amend 02, June 2024
MLL/DAY/AP/001/02, May 2021/Amend 03 - September 2025
MLL/DAY/RP/001/02, May 2021/Amend 03 - September 2025
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)
Matrix Pharmacorp Private Limited
Unit 8, Gaitula Chodavaram, Poosapatirega Mandal, Vizianagaram
Andhra Pradesh
535 204
India