Out of 202 Complete Response Letters issued between 2020 and 2024, 150 involved quality/manufacturing issues, according to the regulator’s newly released documents.
Generics, which make up approximately 90% of prescription volume in the U.S., are produced primarily in India as Hikma looks to onshore production of these critical drugs.
The tariffs on pharmaceuticals would have a grace period of up to a year and a half to give drugmakers the opportunity to move their manufacturing operations to the U.S.
After touring the Fishers facility, William Blair analysts say demand for syringes is “healthy and robust” with a sequential utilization ramp-up expected in coming quarters.
Alessandro Maselli, who took the helm in 2022, has navigated the global CDMO through the COVID-19 pandemic and the landmark $16.5 billion acquisition by Novo Holdings.
While jobs dropped 3.7% last year, the state is still home to the largest number of manufacturing-related life science jobs in the U.S., according to Biocom California.
The strategic realignment is aimed at better serving customers across the drug development lifecycle, from research and discovery to clinical and commercial manufacturing.
The company is working with the CDMO partners in the U.K. and Spain to prepare for potential launch of MYR-101 for Canavan disease, pending regulatory approvals.
The new 194,000-square-foot lab complex will house chemical, microbiological and biological testing facilities to support the growing Tianjin plant’s output.
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