Forma Life Sciences begins US operations with oral dosage GMP sites

Forma Life Sciences, a contract development and manufacturing organization (CDMO) headquartered in Irvine, California, has launched as an independent company focused on oral solid dosage formulation development, clinical manufacturing, and commercial drug product manufacturing in the United States.

The company was established following BioSelective Capital Investments’ acquisition of the U.S. drug product development and manufacturing operations of BioDuro, a global CDMO. The transaction included two established GMP facilities in Irvine with a regulatory track record supporting clinical and commercial oral solid dosage programs.

Forma operates two cGMP-compliant facilities totaling more than 100,000 square feet and encompassing 27 GMP manufacturing suites. The sites support oral solid dosage formulation development, clinical manufacturing for Phase I through III programs, process scale-up, technical transfer, and commercial drug product manufacturing. The platform has the capacity to produce more than two billion tablet and capsule units annually.

The company also provides formulation development and manufacturing services for tablets and capsules from early clinical development through commercial production. Capabilities include spray-dried dispersion for amorphous solid dispersion systems as well as commercial-scale fluid bed granulation and coating for modified-release and multiparticulate dosage forms, including matrix-based controlled- and delayed-release technologies.

“For more than 30 years, this organization has supported the pharmaceutical supply chain,” CEO Cyrus Mirsaidi said in a statement. “Forma was created to preserve that operating foundation while building a focused U.S.-based CDMO platform designed for disciplined execution and long-term partnership.”

“Our industry is seeing renewed focus on domestic pharmaceutical manufacturing and supply chain resilience,” added Armand Amin, president of Forma Life Sciences. “Forma provides a durable, U.S.-based development and manufacturing platform that pharmaceutical and biotechnology partners can rely on from clinical development through commercial supply.”