Product details
WHO Product ID
WHOAPI-364b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Micronised
INN
Pyrimethamine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Anuh Pharma Ltd
E17/3 & 17/4 & E-18 MIDC, Boisar Tarapur Taluka-Palghar, Thane District
Maharashtra
401 506
India
APIMF Version Number
ANUH/PYRIMETHAMINE/APPLICANT PART/03/09-22
ANUH/PYRIMETHAMINE/RESTRICTED PART/03/09-22
ANUH/PYRIMETHAMINE/APPLICANT PART/03/09-22/AMEND 01 JANUARY 2023
ANUH/PYRIMETHAMINE/RESTRICTED PART/03/09-22/AMEND 01 JANUARY 2023
ANUH/PYRIMETHAMINE/RESTRICTED PART/03/09-22/AMEND 02 JUNE 2023
ANUH/PYRIMETHAMINE/APPLICANT PART/03/09-22/AMEND 02 JUNE 2023
ANUH/PYRIMETHAMINE/APPLICANT PART/03/09-22/AMEND 01 APRIL 2024
ANUH/PYRIMETHAMINE/RESTRICTED PART/03/09-22/AMEND 01 APRIL 2024
ANUH/PYRIMETHAMINE/RESTRICTED PART/03/09-22
ANUH/PYRIMETHAMINE/APPLICANT PART/03/09-22/AMEND 01 JANUARY 2023
ANUH/PYRIMETHAMINE/RESTRICTED PART/03/09-22/AMEND 01 JANUARY 2023
ANUH/PYRIMETHAMINE/RESTRICTED PART/03/09-22/AMEND 02 JUNE 2023
ANUH/PYRIMETHAMINE/APPLICANT PART/03/09-22/AMEND 02 JUNE 2023
ANUH/PYRIMETHAMINE/APPLICANT PART/03/09-22/AMEND 01 APRIL 2024
ANUH/PYRIMETHAMINE/RESTRICTED PART/03/09-22/AMEND 01 APRIL 2024
Product Grades
API specification number
FPS/WHOPMT/034-05 (micronised)
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Primary: Polyethylene bag; Secondary: HDPE drum
API Manufacturing Site(s)
Anuh Pharma Ltd
E17/3 & 17/4 & E-18 MIDC, Boisar Tarapur Taluka-Palghar, Thane District
Maharashtra
401 506
India