The agency wants to increase the fee starting in fiscal 2028 for all foreign API, finished dosage form, and contract manufacturing organization facilities.
The facility in Yangzhou, China completed a five-day preapproval inspection covering oligonucleotides, GLP-1 peptide, and small molecule manufacturing.
The acquisition adds 40,000 square feet of GMP manufacturing capacity, including two 1,000-liter single-use bioreactors and a dedicated bioconjugation suite.
