The drug substance manufacturing site(s) proposed for registration in Singapore as listed below is(are) the same as that approved by the specified reference agency. Manufacturing Activity Name and Address of the site(s) Manufacturing [To indicate only one site in each row] Manufacturing (final process [To duplicate row if necessary] step, e.g. purification/ crystallization or micronisation) The drug substance manufacturing process proposed for registration in Singapore is the same as that approved by the specified reference agency. The container closure system and retest period proposed for registration in Singapore as listed below are the same as that approved by the specified reference agency. Container Closure Storage Re-test Period Shelf Life System Conditions (if applicable) Drug Product The drug product manufacturing site(s) proposed for registration in Singapore as listed below is(are) the same as that approved by the specified reference agency. Manufacturing Activity Name and Address of the Site(s) Drug Product Intermediate [To indicate only one site in each row] Bulk Production [To duplicate row if necessary] Primary Packaging Sterilisation Secondary Packaging Batch Release
The drug substance manufacturing site(s) proposed for registration in Singapore as listed below is(are) the same as that approved by the specified reference agency. Manufacturing Activity Name and Address of the site(s) Manufacturing Manufacturing (final process step, e.g. purification/ crystallization or micronisation) [To indicate only one site in each row] [To duplicate row if necessary] The drug substance manufacturing process proposed for registration in Singapore is the same as that approved by the specified reference agency. The container closure system and retest period proposed for registration in Singapore as listed below are the same as that approved by the specified reference agency. Container Closure System Storage Conditions Re-test Period Shelf Life (if applicable) Drug Product The drug product manufacturing site(s) proposed for registration in Singapore as listed below is(are) the same as that approved by the specified reference agency. Manufacturing Activity Name and Address of the Site(s) Drug Product Intermediate Bulk Production Primary Packaging Sterilisation Secondary Packaging Batch Release [To indicate only one site in each row] [To duplicate row if necessary]
Appendix%2018A_Dossier%20Clarification%20Supplement.docx