The newest FDA Form 483 says Zhejiang Huahai Pharmaceutical made production changes to valsartan API without thoroughly testing them.
Cambrex finalizes $425 million acquisition of dosage-form CDMO Halo Pharma and its two manufacturing plants.
Rubius Therapeutics kicked off a $155 million renovation of a former Alexion facility that was shuttered last year.
Polisano Pharmaceuticals is now under the control of rail freight group Grampet after the company upped its stake in the drugmaker from 20% to 74%.
GlaxoSmithKline has made a small investment in a manufacturing site in Canada in part to make an OTC pain reliever.
Jiangsu Yew Pharma had its European marketing authorization suspended for refusing to allow inspectors into a manufacturing facility.
The FDA said it uncovered a second and unexpected cancer-causing impurity in three batches of the blood pressure medicine valsartan that were sold by Torrent…
Drug manufacturers were shaking off the remnants of Hurricane Florence on Monday after the dangers from the storm morphed into hazardous flooding.
India’s Sun Pharmaceuticals, which is working to shift its focus to novel and specialty drugs, has won FDA approval of a new treatment for glaucoma.
Cook Pharmica, a biologics manufacturing company Catalent bought last year, was hit with a Form 483 by the FDA.