Antibiotics (CMO business)
Master File registration
Master File registration, maintenance, and management
When orchestrating Master File registration of active pharmaceutical ingredients procured overseas, companies are required to assign an in-country caretaker.
The in-country caretaker works closely with marketing authorization holders as well as with overseas manufacturers to conduct audits as necessary.
The in-country caretaker is also responsible for Master File management including change control, which ensures there is no divergence from actual manufacturing processes and quality control.
Master File registration track record
We currently serve as the in-country caretaker for the following pharmaceuticals’intermediates and raw materials:
|Antibiotic classification||Product name|
|Cephalosporin||Cefotiam hydrochloride (JP)
Ceftriaxone sodium hydrate (JP)
Cefepime dihydrochloride hydrate (JP)
|Cephamycin||Cefmetazole sodium (JP)
|Carbapenem||Meropenem hydrate (JP)|