Two sterile compounders hit by FDA warning letters for violating cGMP
The US FDA has lambasted two sterile compounders for violating cGMP in letters citing recent legislation brought in to ensure such companies are fully regulated.
Archives for May 19, 2015
Inhalable biologics: Serendex formulates with Novozymes’ Recombumin
Serendex Pharmaceutical is a step closer to developing an inhalable biopharmaceutical for lung disease after adopting stabilising tech from Novozymes.
Janssen and Rutgers expand R&D as continuous manufacturing picks up steam
Despite pharma being “highly regulated and slow to change,” continuous manufacturing will soon be realised, says Rutgers University which has received an R&D grant from J&J.
Pharmatek bulks out spray dried dispersion services
CDMO Pharmatek has expanded its bioavailability services on the back of client demands, installing new spray dried dispersion equipment.
EMA: show clinical justification for combination drugs
The EMA has released guidelines on developing combination drugs with more than one active pharmaceutical ingredient (API).