Capabilities · Services for imported products
A coordinated route to the Japanese market
One Japan-side workflow across our Saitama and Gunma operations: receipt, GMP storage, visual inspection, secondary packaging, testing support and dispatch coordination.
Regulatory context
A licensed site in Japan for your imported product.
Supplying an imported medicine to Japan requires a domestic set-up that meets Japanese regulatory requirements: Japan-market labeling and packaging, GMP storage and any required testing, with market release decided under the responsibility of the marketing authorization holder (MAH).
Fujimino Pharma performs these operations within the scope of its manufacturing license and acts as the site in Japan for your MAH, whether that is your own affiliate or a Japanese licensing partner. Responsibilities, release interfaces and product requirements are agreed at the start.
In English or Japanese, whichever your team prefers
The workflow
Control at every handover.
Local activities for imported products easily become fragmented. We run them as individual services or as one integrated workflow, from receipt to onward supply.
- 01
Receipt & status control
Inbound verification, document checks, temperature-data review, quarantine, inventory status.
- 02
GMP storage
Ambient, refrigerated or frozen, per the approved product requirements.
- 03
Visual inspection
Product-specific inspection against approved standards, defect classifications and procedures.
- 04
Secondary packaging
Labeling, over-labeling, leaflet insertion, cartoning, coding and other approved operations.
- 05
Testing & documentation
Agreed QC activities, batch documentation and exchange with the responsible quality and release organizations.
- 06
Onward supply
Dispatch coordination and handover to your nominated distribution network.
GMP storage
Three temperature zones, matched to your product’s requirements.
Our Gunma warehouse operates under Fujimino Pharma’s license. Cold-chain handling can be arranged to match your product and supply route.
GMP storage at ambient temperature
Refrigerated storage
Frozen storage
Final service scope depends on product requirements and technical assessment.
Inspection
Visual inspection.
Performed by dedicated, qualified operators with QC oversight. The inspection method is defined during transfer.
- Inspection standards. Product-specific defect definitions and approved acceptance criteria.
- Qualified operators. Training and qualification against the approved inspection procedure.
- Controlled conditions. Defined environment, handling conditions and inspection parameters.
- QC oversight & documentation. Sampling, reconciliation, batch documentation and escalation of defects.
Packaging
Secondary packaging.
Final scope is defined after review of pack components, approved artwork, volumes and line configuration.
Reliable supply depends on disciplined control at every handover. We keep product status, responsibilities and documentation clear from receipt through final dispatch.
Starting a project
Define the Japan-side workflow early.
We typically begin by reviewing the product flow, responsible parties, release model and target transfer or launch timing.
A confidentiality agreement can be arranged before technical information is exchanged.
Typical information for an initial review
- Dosage form and pack configuration
- Annual volume
- Storage conditions
- Inspection and packaging scope
- Testing requirements
- Target timing