Product details
WHO Product ID
WHOAPI-232
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Diarrhoea
Grade
Standard
INN
Zinc (sulfate)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Dr Paul Lohmann GmbH & Co KGaA
Haupstrasse 2
Emmerthal,
D-31860
Germany
APIMF Version Number
O59-USP-AP-V.05-WHO
O59-USP-RP-V.05-WHO
O59-USP-RP-V.05-WHO
Product Grades
API specification number
Version number O59/097 (14.11.2019)
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
36
Duration type
Retest period
Packaging
Single high density polyethylene (HD-PE) bags. The bags are tightly closed using strong PE-cable binders. Secondary packaging: multilayer paper bags, fibre drums, or cardboard boxes in different sizes.
API Manufacturing Site(s)
Dr Paul Lohmann GmbH & Co KGaA
Haupstrasse 2
Emmerthal,
D-31860
Germany