Product details
WHO Product ID
WHOAPI-226
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Reproductive health
Grade
Standard
INN
Misoprostol Dispersion (1:100 in HPMC)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Piramal Healthcare UK Ltd
Whalton Road
Morpeth,
Northumberland
NE61 3YA
United Kingdom
APIMF Version Number
Misoprostol Dispersion/OP/03/Oct-2020
Misoprostol Dispersion/RP/03/Oct-2020
Misoprostol Dispersion/RP/03/Oct-2020
Product Grades
API specification number
Misoprostol Dispersion WHO APIMF226-3 version 1.0
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from moisture, protect from ligh
Storage period (months)
60
Duration type
Retest period
Packaging
Either a conventional double additive free food grade polythene bag or an additive free food grade continuous polythene liner. Both are sealed in Polyester/ Aluminium/ Polythene laminate pouch then put it in a fibre board drum.
API Manufacturing Site(s)
Piramal Healthcare UK Ltd
Whalton Road
Morpeth,
NE61 3YA
United Kingdom of Great Britain and Northern Ireland