Contract
Development &Manufacturing
Organiza�onYour Strategic Partner for
Expert Drug Development andManufacturing

CMIC GroupEMAIL: informa�on@cmic.co.jp
WEBSITE: h�ps://en.cmicgroup.com© CMIC HOLDINGS Co, Ltd.

Bridging the West with the East

Our CDMO Plants and Capabili�esCMIC Group, the largest and first CRO in Japan, expanded its capabili�es into contract development andmanufacturing services among its other end-to-end solu�ons for the pharmaceu�cal industry. With the acquisi�onof high standard facili�es from global pharmaceu�cal companies in Japan and specialized dose form technology inthe U.S. and South Korea, CMIC Group can provide drug development exper�se with advanced manufacturing andpackaging pla�orms to help accelerate your drug development �meline. Whether you are launching new drugs inthe U.S. or considering new market entry for the Japanese market, we are your partner for global productdevelopment with the ability to seamlessly transfer technologies across borders for manufacturing. With our broadofferings, we can help you �e your development and commercializa�on needs in the West with the East.

New Jersey, United States

PRE-CLINICALAPPROVAL

CLINICAL PHASE I-IIIEmploying a team of experts with an average tenure of 17+ years, our U.S. loca�on specializes in formula�ondevelopment and manufacturing for both clinical and commercial oral solid dose products. The state-of-the-art GMP
compliant facility with all cri�cal u�li�es (USP Water, Compressed Air, etc. including an emergency back-up generator
for cri�cal systems) has strong exper�se in fluid bed technology including Wurster, GXR/rotor and granula�onprocesses, as well as compression, encapsula�on and func�onal and non-func�onal tablet coa�ng opera�ons. Thefacility also has dedicated R&D suites for product developmental ac�vi�es and large GLP compliant Quality Controland Analy�cal R&D Laboratories and stability chambers. We are expanding our New Jersey loca�on’s capacity andwill include contract packaging as a service in 2021.

POST-APPROVAL

Nishine, Japan
Consul�ng Services

The Nishine Plant has strengthened CMIC’s pharmaceu�cal development and manufacturing capabili�es bycombining technological capabili�es and high quality control brought by the support of our other CDMO plants. Thissite has allowed for further flexibility and prompt services tailoring to various needs of domes�c and overseas
pharmaceu�cal companies. The Nishine Plant provides commercial manufacturing of granules, tablets and capsules,
inspec�on and packaging for blister and bo�le packaging as well us scale-up study and technology transfer.

• Product life cycle management

Regulatory Affairs• CMC consul�ng

APIShizuoka, Japan• Exploring synthe�c pathways• Establish synthe�c procedure (Op�miza�on, scale-up, tech-transfer)• Solubiliza�on of poorly aqueous compounds*packagingonly*packagingonly*packagingonly

Our Shizuoka plant has over 50 years of history providing high quality inves�ga�onal and commercial productdevelopment, manufacturing and packaging of various dosage forms for the pharmaceu�cal industry. With ourdedicated Pharmaceu�cal Development Center (PDC), scien�fic exper�se and high quality management ofmanufacturing and packaging for near 100 products annually, we can help you solve your inves�ga�onal andcommercial product development challenges to meet your project �melines.

Formula�on, Process and Analy�cal Development• Preformula�on¹,²• Formula�on design¹,²• Process development (scale-up and op�miza�on)¹,²• Packaging design¹,²• Analy�cal method development & valida�on¹,²

Ashikaga, JapanInves�ga�onal Product Manufacturing*packagingonly• Early to late phase manufacturing¹• Visual inspec�ons per Japanese requirements• Packaging and labeling• Release and stability tests¹• Labeling for randomiza�on studies

Ashikaga plant features state-of-the-art equipment able to manufacture lyophilized vials and sterile solu�on vial forHighly Potent Ac�ve Pharmaceu�cal Ingredients (HPAPI), biologics and small molecules. The plant also manufactures
sterile solu�on ampoule for biologics and small molecules, and oral dose forms. In addi�on, the site’s unique loca�onprotects it from power loss, pulling its power from mul�ple sources and providing peace of mind.

Technology Transfer

Gyeonggi-do, South Korea• Analy�cal and manufacturing method transfer¹,²

CMC Regulatory Services

In addi�on to the manufacturing and packaging of commercial semi-solid products, our plant in South Korea iscapable of import and export of medicinal products allowing easy interna�onal market access. With its capability ofproac�ve product development, the plant can also offer its own products for out-licensing. With good understanding
on product line development, our experienced staff will handle every product as their own to meet your needs.

• CTD prepara�on¹,²• Regulatory correspondence¹,²

Commercial Supply• Valida�on batches¹,²• Transporta�on tests• GMP audits¹,²• Commercial manufacturing¹,²• Visual inspec�ons per Japanese requirements• Packaging and labeling• Release and stability tests¹,²• Sample storage¹,²• Prepara�on of annual report¹,²
All services are provided in Japan¹ Services also provided in the U.S.
² Services also provided in South Korea

Toyama, Japan
Toyama plant specializes in inves�ga�onal and commercial manufacturing and packaging of liquid and semi-solid
dosage forms, with the capability and safety features for manufacturing products with high-alcohol content.

Learn More: h�ps://en.cmicgroup.com/cdmo