Novo Holdings acquires The Ritedose Corporation and fully automated packaging lines increased to six
Commercial launch of 503B Outsourcing Facility
ICH Stability program to support semipermeable conditions. Regulatory team supports project throughout regulatory lifecycle.
Dedicated multidisciplinary team to support all aspects of development from method development, method validation, sterility & bioburden along with our robust microbiology lab.
Development engineering teams lead all aspects of product development/transfers from the clinical study stage and manage projects throughout the development lifecycle, process validation & commercial launch.
TRC registers with FDA as a 503B Outsourcing and Repackaging Facility
Plant expansion of over 150,000 sq ft for packaging and distribution
TRC obtains fourth ANDA and operating capacity reaches 2.1 billion units with 10 BFS machines, five fully automated packaging lines and one semi-automated packaging line
EU compliant expansion Quality & Development Lab expansion
TRC launches Ritedose Pharmaceuticals (RDP) and obtains third ANDA