Product details
WHO Product ID
WHOAPI-379
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Influenza
Grade
Standard
INN
Oseltamivir (phosphate)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Laurus Labs Limited
2nd Floor, Serene Chambers, Road No. 7, Banjara Hills
Hyderabad,
Telangana
500 034
India
APIMF Version Number
LL/Oseltamivir Phosphate/OP/01/May-2020
LL/Oseltamivir Phosphate/RP/01/May-2020
LL/Oseltamivir Phosphate/RP/01/May-2020
Product Grades
API specification number
FS/AOTV/03 Version No 2.0
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
transparent Low Density Poly Ethylene (LDPE) bag, fill the bag with nitrogen, twist the bag and tie it with strip seal. The bag is placed in another transparent LDPE bag filled with nitrogen. Keep silica gel packets between the 2 bags, twist the bag and tie it with strip seal.
API Manufacturing Site(s)
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India