美国 FDA 发布2025 年第一份指南草案，题为“遵循 21 CFR 211.110 的考量因素”，协助制药商遵守这一章节的法规条款，以确保批次一致性和药品可靠性。

The FDA's Good Manufacturing Practice (GMP) regulations provide a framework of essential requirements for the methods, facilities and controls used in manufacturing, processing and packaging of a drug ...

Granules India receives FDA approval for generic ADHD drug, expanding portfolio and reinforcing presence in treatment space.

NMD Pharma A/S, a clinical-stage biotech company dedicated to developing novel and improved treatments for patients living with neuromuscular diseases, announces that the US Food and Drug ...

Of India’s 10,000 MSME drug companies, only 2,000 are WHO GMP-certified ... president of the Federation of Pharmaceutical Entrepreneurs (FOPE). Manawat said FOPE welcomed the one-year extension ...