SHIGA, JAPAN
A Letter from Leadership
Thank you for your interest in visiting Catalent’s Shiga site, which operation started in October 2021!
The 60,000 newly opened square-foot-facility is the largest in the Catalent’s Asia Pacific clinical supply network, and offers flexible clinical supply solutions for both local and global biotech and pharmaceutical companies. Our capabilities include GMP compliant primary and secondary packaging, in-house label printing, storage and distribution with a range of temperature options, as well as clinical returns and destruction services. Shiga, the 3rd Catalent site in Japan, is operating in partnership with the Softgel manufacturing facility in Kakegawa and the business development team located in the Catalent Japan Tokyo office.
We are committed to Catalent’s “Patient First” culture in order to reliably supply clinical material to our customers in Japan, Asia and around the world. We look forward to hosting you in the Shiga site and demonstrate our capabilities in innovative supply solutions, quality and customer service excellence.
We always welcome your suggestions, and are ready to improve by all means to better meet your needs in the region.
On behalf of the Site employees, thank you for your visit and welcome to Shiga Japan.
Tracey Clare
General Manager, APAC Region
Mitsuru Iwasaki
Site Director, Shiga Site
OUR CAPABILITIES INCLUDE:
- Project/Supply Chain Management
- Clinical Trial Material Forecasting
- Comparator & Reference Drug Sourcing
- GMP Primary Packaging of Clinical Supplies
- GMP Secondary Packaging
- In-House Label Printing
- Clinical Storage and Distribution
- Cold Chain & Specialty Handling
- Return and Destruction
OUR TECHNOLOGIES INCLUDE:
- Amber & Refrigerated Storage Capacity (15-25°C,2-8°C)
- Freezer Storage Capabilities (-20°C, -40°C &-80°C)
- Cryogenic Storage Capability
- Primary Packaging: Blistering Line and Bottling
- Secondary Packaging: Kit Assembly, Label Application and Scan verification
- Card sealer
- FastChain™ Demand Led Supply
Click here to take a virtual 360° tour of our Shiga site.
For more information about our Shiga site visit our locations page.
Click here for directions to the Catalent Shiga site.
Click here to learn more about Catalent’s vision, mission, and values, as well as our Corporate Responsibility and Diversity & Inclusion strategies.
Visitor Health Statement
2019 NOVEL CORONAVIRUS (COVID-19)
Catalent is committed to the health and safety of its employees, visitors, and the customers and patients we serve. In light of the Coronavirus outbreak, we have put in place restrictions on access to our sites based on a visitor’s travel history, contact with potentially infected persons, and whether one is experiencing certain health conditions.
By entering our site, you confirm that you meet the following requirements:
I have not traveled across any restricted international borders, or have travelled from restricted zones, as dictated by regional or country legislation, within the past 15 days.
I have not been in physical or close contact (i.e., within 2m/6ft) with anyone whom I believe may be infected with or has been diagnosed with COVID-19.
I have not experienced any of the following within 15 days of visiting this site:
- Fever or chills
- Cough
- Shortness of breath or breathing difficulty
- Fatigue
- Muscle or body ache
- Diarrhea
- Headaches
- New loss of taste or small
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
Only persons answering yes to all statements will be allowed to enter this facility.
Visitors to Catalent Shiga will be required to wear a face mask when on site.
Catalent takes the health and safety of its employees extremely seriously. As such, if you should exhibit the symptoms of, or test positive for, COVID-19 over the next 14 days, we would request that you contact your Catalent host, so that Catalent can take all possible measures to prevent the spread of the virus.
Key Shiga Site Information
Welcome to Shiga site! Our 60,000 square-foot-facility started its operation in October 2021 to become a new clinical GMP manufacturing and distribution hub to support clinical studies for both local and global biotech and pharmaceutical companies. Our main capabilities include full clinical supply service ranging from GMP compliant packaging and labelling, handling ambient controlled, refrigerated, cold chain and deep-frozen goods to handling of temperature-sensitive products in our separate modern temperature and humidity controlled warehouse with cold storage facilities. Our vision is to be the world’s most trusted, reliable and innovative drug development and delivery partner by upholding the highest industry standards and exceeding customer expectations.
SECURITY
- Please park in parking areas.
- Please observe speed limits and stop signs while driving on the premises and yield to pedestrians.
- All vehicles and articles are subject to inspection.
- Visitors should be accompanied by an employee at all times within the facility.
- Taking photographs or videos is not allowed on site.
- Weapons, including privately owned firearms, are strictly prohibited on plant property.
- All persons visiting the site must be pre-registered by the host and be registered on their arrival at the front register door. Visitors are issued and must wear a name tag at all times while on site. All visitors are required to check out at the front register desk before leaving the site.
SAFETY & EMERGENCY
- You will be provided with personal protective gowning requirements relevant to the areas visited during your stay. Jewelry will need to be removed prior to entering GMP Production areas.
- We have a special visitor aisle for customer to see the production process through the window, which is out of the GMP areas. In this case, the above requests will not be applied if visitors only stay in the designated areas. Please take shoes off and wear side shoes before entering.
- In the event of a fire emergency, a long continuous alarm will sound. Your Catalent host or a member of the fire marshal team will escort you to the nearest exit door.
- Accident or Injury – If you have an accident or feel ill, inform your host who will arrange for first aid.
GOOD MANUFACTURING PRACTICES (GMP)
- The Pharmaceutical facility follows to Good Manufacturing Practice (GMP) guideline.
SIGNS & WARNINGS
- Please be aware of displayed warning/personal protection signs and adhere to instruction issued by Catalent staff.
- Follow all posted signage relating to COVID-19, i.e. wearing masks, social-distancing, handwashing, etc.
- Do not enter restricted areas or touch any product, materials, machinery controls or equipment, unless authorized to do so by a Catalent employee.
IT
- Catalent offers wireless internet access for our guest. Your host will pre-register you and make arrangements for internet access during your visit.