Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantNOVEM PHARMA PRIVATE LIMITED
Licence HolderNOVEM PHARMA PRIVATE LIMITED
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
INTRAVENOUS
Medical Information
J01DH03
ertapenem
Manufacturer Information
NOVEM PHARMA PRIVATE LIMITED
ACS Dobfar S.p.A. (DP intermediate)
ACS Dobfar S.p.A. (primary and secondary packager)