Capabilities · Partner network
International manufacturing, connected to Japan
Since 2026, our partnership with Gensenta, an Eczacıbaşı Healthcare company, extends our platform to sterile injectables and oral solid dose forms, supporting technology transfer and commercial supply for Japan and international markets.
Gensenta at a glance
Established scale. International reach.
Gensenta supplies pharmaceutical products across Europe, Asia, the Middle East and other international markets, within multiple regulatory frameworks.
pharmaceutical manufacturing heritage
across the organization
international supply experience
commercially supplying products to Japan
Figures on this page describe Gensenta’s platform. Capacity availability and product suitability are confirmed for each project.
The partnership
A broader platform. A clear local interface.
Manufacturing partner · Türkiye
Gensenta
Performs the sterile injectable and oral solid dose manufacturing, supported by a long international supply history and regulatory experience across multiple markets.
Your interface in Japan
Fujimino Pharma
Coordinates the agreed Japan-side requirements, technical interfaces and local supply activities, with technology-transfer experience and an operating presence in Japan.
Successful international manufacturing depends on more than technical capability alone. Quality alignment, clear communication and disciplined execution need to work across organizations and markets from the beginning.
Manufacturing scope
Sterile injectables.
Aseptic fill-finish: established commercial sterile manufacturing on multiple vial-filling and lyophilization platforms.
3 established vial lines
~39,000 vials/hour combined filling capacity.
6 freeze dryers
~168 m² lyophilization capacity on the established lines.
24,000 vials/hour
New Annex 1-compliant isolator line for liquid and lyophilized products, with 38.7 m² lyophilization capacity.
300 / 1,000 L
Commercial formulation scales on the new platform.
The new aseptic isolator platform supports clinical and commercial manufacture of liquid and lyophilized vial products in accordance with current EU GMP Annex 1 requirements.
Manufacturing scope
Oral solid dose manufacturing.
Tablets and capsules: integrated commercial manufacturing from dispensing and granulation through compression, coating, capsule filling and packaging.
installed tablet manufacturing capacity
installed capsule manufacturing capacity
Integrated manufacturing
- Granulation
- Blending
- Tableting
- Coating
- Capsule filling
- Packaging
Development support
Japan readiness
Consider the market from the beginning.
A viable manufacturing process is only one part of a successful Japan program. The technical-transfer plan and the Japan regulatory pathway develop in parallel, not in sequence.
Technical & analytical requirements
- Comparability and validation requirements
- Analytical-method and specification transfer
- Stability commitments
Regulatory & quality interfaces
- Dossier and marketing-authorization status
- Required manufacturing-site changes
- Importation and release model
Packaging & local supply
- Japan-market packaging and artwork
- Visual-inspection requirements
- Storage and distribution temperatures
- Forecast volumes and launch timing