CMC Pharmaceuticals, a leading provider of drug product development services, announces that operations at its Ohio locations have continued and expanded during the COVID-19 pandemic. Our administrative functions have been effective working remotely, and CMC has established on-site guidelines to protect our employees with appropriate social distancing and other procedures in our laboratories. In the previous 12 months, CMC Pharma has:

• Continued operations throughout Ohio’s Stay at Home Order as an Essential Business that provides laboratory and product development services to our pharmaceutical and biotechnology customers.
  
• Expanded our long-acting, controlled-release drug delivery capabilities with a focus on cost-effective solutions.
• Established a manufacturing pilot plant to produce a wide variety of oral, injectable, and long-acting drug product prototypes.
• Expanded lab instrumentation and personnel to double our analytical capacity with new ICH Stability Chambers, UHPLCs, and other analytical instrumentation.
• Established cGMP laboratory capabilities for analytical development and validation, stability and compatibility studies, and drug product release testing
• Added additional personnel protective equipment (PPE) and lab safety equipment for the safe handling of potent actives.
• Expanded our relationship with the Federal Government for the development of drugs by winning multiple DOD grants and contracts
• Submitted COVID-19 proposals to identify and develop pharmacotherapies by providing chemistry, manufacturing, and controls (CMC) support (e.g., manufacturing scale-up).

These milestones and capabilities have provided services to our customers for the development of critically needed drug products. CMC Pharma has continued to expand our lab services to develop or improve drug product formulations, prepare prototypes of a variety of dosage forms, conduct stability and material compatibility studies, and create or optimize analytical methods that are suitable for inclusion in our clients U.S. FDA and other worldwide regulatory submissions.

“CMC Pharma was started nearly 6 years ago to quickly develop robust formulations needed for drug approval and large scale manufacturing. Our organization is well positioned to help identify, scale-up and test formulations to ensure Quality drug products that are critically needed to fight the current pandemic,” stated Mike Radomsky, Founder and President of CMC Pharmaceuticals. “CMC is excited to partner with other organizations to develop new treatments for COVID-19 and will continue our partnerships to advance pharmacotherapies and other medical countermeasures to address unmet medical needs.”

About CMC Pharmaceuticals, Inc.:

CMC Pharmaceuticals is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. CMC Pharmaceuticals delivers its specialized scientific expertise and services including pre-formulation, formulation development, analytical development, cGMP lab services, stability and compatibility studies, manufacturing process development and consulting services to clients globally. CMC Pharmaceuticals offers decades of specialized scientific experience in the development and manufacture of a wide range of drug product types including sterile, solid, semi-solid/liquid, topical, long-acting, controlled release, and other complex dosage forms. www.cmcpharm.com

CMC Pharmaceuticals has added current Good Manufacturing Practices (cGMP) lab services at its Solon, OH location on October 1st. This addition includes the upgrading of laboratory SOPs and documentation practices to comply with U.S. FDA guidelines. Now, data generated in CMC’s lab may be included or used to support contract customer’s filings with the U.S. FDA when cGMP lab studies are required. CMC Pharmaceuticals can now develop or improve drug product formulations, prepare prototypes of a variety of dosage forms, conduct stability and material compatibility studies, and create or optimize analytical methods that are suitable for inclusion in their clients U.S. FDA submissions.

This upgrade in capability extends CMC Pharmaceuticals ability to support their customer’s needs in drug product development services. “We started this organization five years ago to help pharma and biotech companies develop robust drug products faster,” said Mike Radomsky, Founder and President of CMC Pharmaceuticals. “This logical expansion of our service offering is in response to the expanding needs of our valued customers and allows us to directly support them with their submissions to the FDA”.

CMC Pharmaceuticals continues to operate its Mid-town Cleveland laboratory with a focus on R&D services, providing for early stage research laboratory services.

Cleveland, Ohio – October 14, 2019

CMC Pharmaceuticals announces a celebration of the five-year anniversary of its founding on October 3, 2019. CMC Pharmaceuticals hosted the celebration at its newest laboratory location. Guests were customers, suppliers and local government, including Solon (Ohio) Mayor Ed Kraus, Solon Director of Business and Marketing, Angee Shaker, Solon Councilman, Bill Russo and 14^th District Congressman David Joyce’s Representative, Katie Burger. The event included a tour of CMC Pharmaceutical’s facilities to mark the important occasion.

Dr. Mike Radomsky founded CMC Pharmaceuticals in 2014, based on a mission to help pharma and biotech companies, non-profit institutions, and government agencies develop high-quality drug products more efficiently. CMC Pharmaceuticals added laboratory facilities in 2015 to provide experimentally-based, data-driven development solutions to address its customer’s drug product development and manufacturing challenges. The company has grown to two laboratory locations in the Cleveland area and increased its staff from just the original founder, to now include 10 highly experienced team members with advanced scientific backgrounds. 

The majority woman-owned business now offers fully integrated formulation development, analytical development, drug product stability, and process development services from its own R&D and current good manufacturing practices (cGMP) laboratories.  CMC Pharmaceuticals co-founder Casey Loveland commented, “ The Cleveland area has been a great place to grow our business, with its central location, and highly developed medical and scientific infrastructure. It has definitely contributed to the acceleration of our growth”. 

“Having started a single person consulting firm that now successfully operates as a growing organization with a wide range of global customers is a great achievement for CMC Pharmaceuticals,” said Mike Radomsky, Founder and President of CMC Pharmaceuticals. “Over the last 5 years we’ve expanded our services and operations to meet our customer’s needs. We’ll assess new opportunities to continue that strategic growth moving forward.”