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WHOAPI-517: Amodiaquine (hydrochloride)

Product details
WHO Product ID
WHOAPI-517
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Amodiaquine (hydrochloride)
Applicant organization
Anuh Pharma Ltd.
E17/3 & 17/4 & E-18 MIDC, Tarapur Boisar Dist. Palghar
Maharashtra
401 506
India
APIMF Version Number
ANUH/AMODIAQUINE HYDROCHLORIDE/APPLICANT PART/00/SEPTEMBER-2024
ANUH/AMODIAQUINE HYDROCHLORIDE/RESTRICTED PART/00/SEPTEMBER-2024
ANUH/AMODIAQUINE HYDROCHLORIDE/APPLICANT PART/00/SEPTEMBER-2024- AMEND-01-JUNE 2025
ANUH/AMODIAQUINE HYDROCHLORIDE/RESTRICTED PART/00/SEPTEMBER-2024-AMEND-01-JUNE 2025
ANUH/AMODIAQUINE HYDROCHLORIDE -AP-00-Sep 2024-Amend-02-Nov 2025
ANUH/AMODIAQUINE HYDROCHLORIDE -RP-00-Sep 2024-Amend-02-Nov 2025
ANUH/AMODIAQUINE HYDROCHLORIDE/APPLICANT PART/00/SEPTEMBER-2024-AMEND-03-MARCH 2026
ANUH/AMODIAQUINE HYDROCHLORIDE/RESTRICTED PART/00/SEPTEMBER-2024-AMEND-03-MARCH 2026
Product Grades
API specification number
FPS/ADQ/092-03
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
24
Duration type
Retest period
Packaging
Primary packaging components: double transparent LLDPE bags
Secondary Packaging components: HDPE drum or Fibre drums
API Manufacturing Site(s)
Anuh Pharma Ltd.
E17/3 & 17/4 & E-18 MIDC, Tarapur Boisar Dist. Palghar
Maharashtra
401 506
India
Oneiro Lifecare Private Limited
S. No. 475/P, At & Post- Ekalbara- 391440 Ta. Padra, Dist.- Vadodara
Gujarat
India

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