Update
PE-backed CMO expands syringe filling capabilities
Grand River Aseptic Manufacturing (GRAM) has purchased a new syringe filler to help meet "the rising demand" for parenteral development and manufacturing services.
Archives for March 6, 2018
Drug compounder seeks FDA restraining order, agency takes legal action
The FDA is seeking legal action against a 503B registered outsourcing facility, which is in the process of requesting an emergency hearing to file a restraining order against the agency.
No chewing, grinding or snorting: Recipharm adds Altus anti-abuse tech
A license agreement will allow Recipharm to offer its customers Altus Formulation’s INTELLITAB and FLEXITAB anti-abuse drug delivery technologies.
Limited access to EU Hub could threaten serialization readiness, says CMO
Only marketing authorisation holders, and not CMOs or third-party logistic providers, will be able to report to the European Hub for serialisation compliance, says drug database coordinator EMVO.
Latest GMP crackdown leaving ‘naive’ cosmetic firms with FDA warnings
Increased enforcement of cGMP on over-the-counter (OTC) drugs is highlighting the grey-area in classification with cosmetic products, a former FDA director says.