A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
The U.S. Centers for Medicare & Medicaid Services (CMS) issued the final rule for data interoperability and prior authorization (PA) for health plans, which is designed in part to improve the PA process used by payers.
Glucometrics Co. Ltd. is rolling out its self-developed application programming interface (API) for diabetes care in steps, and the latest partnership with G2E Co. Ltd. is underway to develop a smart insulin pen loaded with the interface.
In a historic first, the European Commission (EC) sanctioned a pharmaceutical cartel focused on controlling an active pharmaceutical ingredient (API) in the European Economic Area.
The U.S. is making strides in addressing the drug and device supply chain vulnerabilities revealed by the COVID-19 pandemic, but there’s still a lot of work to do to reduce dependance on sole source suppliers and foreign manufacturing, according to a new Health and Human Services (HHS) report.
With COVID-19 taking a toll on the U.S. FDA’s inspection program, warning letters stemming from drug facility inspections have been few and far between for the past two years. Aurobindo Pharmaceutical Ltd., of Hyderabad, India, was one of the exceptions.
A new rule published by India’s Central Drug Standards Control Organization that would require additional tests, trials or even approvals for drugs after changes in their active substances is likely to have only limited impact on companies and the market, despite evoking memories of a bruising patent dispute eight years ago.
Drug regulators throughout China cracked down last year on companies manufacturing and selling counterfeit and substandard drugs and active pharmaceutical ingredients.