CMIC Group was the first and is the largest CRO in Japan with a global footprint; providing end-to-end services for
drug development from preclinical tes�ng, clinical trial management, manufacturing to sales and marke�ng. As partof the CMIC CMO Group with a global network, our US site is planned for con�nued expansion of our development,
analy�cal services and commercial manufacturing capacity and capabili�es. Our commitment is to provide theessen�al resources required to meet your present and future needs.

CMIC GroupEMAIL: bd@cmiccmousa.com
PHONE: 1-609-395-9700
WEBSITE: h�ps://en.cmicgroup.com/ccu© CMIC HOLDINGS Co, Ltd.

CMIC CMO USA has been providing speed and flexibility for drug development and tech transfer needs in the U.S.
for more than 15 years. Employing a team of experts with an average tenure of 17+ years, our U.S. loca�on
specializes in formula�on development 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 (2 USP Water Systems, 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�on processes, as well as compression, encapsula�on and func�onal and nonfunc�onal tablet coa�ng opera�ons. The facility also has dedicated R&D suites for product developmental ac�vi�es,large GLP compliant quality control, analy�cal R&D laboratories and stability chambers. Our most recent expansion
includes contract packaging, including: bo�le, blister and pouch/ki�ng.

While CMIC CMO USA is accustomed to providing full service to our clients, CMIC can also offer a la carte services
based on your specific requirements.

Pharmaceu�cal Development Services
Our formula�on development capabili�es are sharply focused on NDA and ANDA oral solid dosage
products. Our team will collaborate with you to achieve op�mal formula�on for your process. We arecommi�ed to crea�ng robust processes that provide seamless transi�on to commercial manufacturing andul�mately to market.

Facility Offerings

Manufacturing Services

CMIC CMO USA's 225,000 sq� facility is located in Central
New Jersey, within close proximity to major academic
ins�tu�ons and large mul�na�onal pharma companies.
The facility is easily accessible to major highways andinterna�onal airports.

Providing cGMP clinical and commercial manufacturing. Our highly trained staff provides strong exper�sein fluid bed technology including, wurster processes and granula�on, as well as compression encapsula�onand pan coa�ng opera�ons. Our commercial services specialize in solid dosage processes including:• Expanded GMP manufacturing capacity• 60 rooms for commercial produc�on and 20 rooms
for R&D produc�on with dedicated packaging suites• Expanded analy�cal labs, including 4 walk-in stabilitychambers• New packaging lines for bo�le and blister• Fully integrated serializa�on capabili�es• Large refrigerated storage (2-8�C)• Large temperature and humidity controlled room forcapsule storageYour Molecule is our Mission

270 Prospect Plains Road
Cranbury, New Jersey 08512• API and excipient purchasing and release• Cleaning valida�on• Clinical trial materials (CTM) manufacturing• Registra�on batch manufacturing• Process valida�on• Commercial manufacturing• In-process and finished product tes�ng• Bulk packaging

Analy�cal Tes�ng & Valida�on Services
We believe analysis is an essen�al ingredient for success. CMIC offers a full range of tes�ng services andexper�se from development of test methods during the early phases through valida�on support for
product release. We also offer a full spectrum of stability studies.
Analy�cal Services:• Analy�cal method qualifica�on/transfer• Analy�cal method development/qualifica�on/verifica�on• Cleaning verifica�on method development/method valida�on and tes�ng• Analy�cal tes�ng support for development work for selec�on of op�mized formula�on• Raw material and final product tes�ng and release• Stability studies

Specialized Packaging
CMIC will be adding contract packaging to the list of services provided to our customers in thepharmaceu�cal, medical device, OTC and dietary supplement markets. With the acquisi�on of our larger,
state-of-the-art New Jersey based facility, we are building dedicated packaging suites with controlledenvironments as defined by the FDA.
• All packaging suites will be internally regulated for cleanliness• HEPA filtra�on systems, mee�ng temperature and humidity standards for packaging
solid oral dosage products• Packaging capabili�es include:- Blister packaging capable of producing thermoform and cold form blister units- Bo�le packaging• Serializa�on ready lines