TransMedics OCS Liver System was recently granted FDA premarket approval. Dalton Pharma Services is thrilled to be supporting the commercialization of this important novel technology and to be part of TransMedics success.
Dalton Pharma Services, a leading North American Pharmaceutical cGMP CDMO is pleased to announce our manufacturing agreement with TransMedics Group, Inc. for their OCS Liver System. TransMedics Inc. is the world’s leader in portable ex-vivo perfusion and assessment of donor organs for transplantation.
TransMedics was recently granted FDA premarket approval for their OCS Liver System that will be used on organs from donors. Peter Pekos CEO of Dalton Pharma Services said “we are excited to be supporting TransMedics by providing powder filling services in the manufacture of their transformative products which will significantly benefit patients”.
TransMedics President and CEO Waleed Hassanein says “TransMedics is now uniquely positioned to offer its OCS perfusion technology for lung, heart, and liver transplantation. Our goal is to leverage these FDA approvals to make more donor organs available to help patients in need of the life-saving transplant procedure”.
Dalton Pharma Services is thrilled to be part of TransMedics success and we are looking forward to supporting the commercialization of this important and novel technology for protecting donor organs for transplantation.
TransMedics is the world's leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Massachusetts, the company was founded to address the unmet need for more and better organs for transplantation and has developed technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung, and liver failure.
About Dalton Pharma Services:
Dalton Pharma Services is a leading North American cGMP pharmaceutical organization providing integrated drug discovery, development, and manufacturing services. We are FDA-registered and Health Canada approved and bring over 30 years of experience to every project. We deliver fully integrated solutions with an emphasis on speed, flexibility, and quality. Our integrated services (drug discovery, formulation and process development, custom synthesis, cGMP sterile fill/finish of liquids and powders, cGMP API manufacturing and/or dosage form manufacturing, and Accelerated Stability Testing) all at one location helps us to be adaptable, flexible and cost-effective.
Dalton has been named one of the Top 50 Companies to Work for in Canada and has been certified as A Great Place to Work, for five years.
To learn more about our history and capabilities, please visit https://www.dalton.com.
Dalton Pharma Services
349 Wildcat Road