近日，美国FDA检查官对通用技术中国医药所属天方科技辛伐他汀原料药进行了为期五天的GMP现场检查，最终“零缺陷”通过美国FDA GMP现场检查。此次检查是公司全体系首次接受FDA现场检查，并是以零缺陷通过检查，这是公司发展过程中的一个重要里程碑。

近日，汇宇制药收到美国FDA（即美国食品药品监督管理局）出具的现场检查报告（即 EIR），涉及多西他赛注射液10 mg/mL（由Meridian Laboratories, INC委托公司生产）。本次通过检查的生产线为注射剂车间（I）生产线，该生产线的代表产品除多西他赛注射液外，还有 ...

PARSIPPANY, N.J., July 21, 2025 /PRNewswire/ -- Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, has announced it successfully passed the U.S. Food and Drug ...

Fewer field offices and inspectors will increase reliance on manufacturers to ensure product and process quality. The US Food and Drug Administration plans to shut down its regional offices and some ...

The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance aims to ...

Dublin, July 17, 2025 (GLOBE NEWSWIRE) -- The "GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries" training has been added to ResearchAndMarkets.com's offering. Auditing ...

The regulations for food and drugs in the United States, described in Title 21 of the Code of Federal Regulations (CFR), are critical in ensuring safe and ethical drug administration. Whether you are ...

FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities. The need to inspect a growing volume of overseas pharmaceutical manufacturers, but limited FDA resources ...

作为生命科学领域当今最热的“显学”，前沿性的基因研究正吸引越来越多的全球跨国巨头加入。日前，澳交所上市公司EZZ生命科学宣布战略签约领先的跨国制药公司GMP Pharmaceuticals(GMP)和Natural Innovations Group(NIG).据悉，三方协议达成战略合作伙伴关系，旨在开发新 ...

Protracted correspondence between drugmakers and the FDA in sorting out the fixes to GMP violations is likely becoming a high-risk undertaking. The FDA has indicated that from here on in, it will have ...

The US Food and Drug Administration (FDA) has warned South Korean drugmaker Celltrion for good manufacturing practice (GMP) issues at the site where it produces its Remicade biosimilar, Inflectra ...