Product details
WHO Product ID
WHOAPI-234
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Sulfadoxine
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/SULFADOXINE/APPLICANT PART/05/05-22
ANUH/SULFADOXINE/RESTRICTED PART/05/05-22
ANUH/SULFADOXINE/APPLICANT PART/05/05-2022/AMEND 01 FEBRUARY 2023
ANUH/SULFADOXINE/RESTRICTED PART/05/05-2022/AMEND 01 FEBRUARY 2023
ANUH/SULFADOXINE/APPLICANT PART/05/05-2022/AMEND 02 MAY 2023
ANUH/SULFADOXINE/RESTRICTED PART/05/05-2022/AMEND 02 May 2023
ANUH/SULFADOXINE/APPLICANT PART/05/05-2022/AMEND 01 APRIL 2024
ANUH/SULFADOXINE/RESTRICTED PART/05/05-2022/AMEND 01 APRIL 2024
ANUH/SULFADOXINE/RESTRICTED PART/05/05-22
ANUH/SULFADOXINE/APPLICANT PART/05/05-2022/AMEND 01 FEBRUARY 2023
ANUH/SULFADOXINE/RESTRICTED PART/05/05-2022/AMEND 01 FEBRUARY 2023
ANUH/SULFADOXINE/APPLICANT PART/05/05-2022/AMEND 02 MAY 2023
ANUH/SULFADOXINE/RESTRICTED PART/05/05-2022/AMEND 02 May 2023
ANUH/SULFADOXINE/APPLICANT PART/05/05-2022/AMEND 01 APRIL 2024
ANUH/SULFADOXINE/RESTRICTED PART/05/05-2022/AMEND 01 APRIL 2024
Product Grades
API specification number
FPS/WHOSDD/008-06 Version 06
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Primary: Clear double layer polyethene 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