International regulatory collaboration has passed an important early test, providing the faintest glimmer of hope that the FDA might actually be able to achieve some of the conflicting goals ...

WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, today announced that its ...

Manufacturing FDA dings Piramal API plant with Form 483 detailing problems tied to quality control, equipment cleaning and more By Fraiser Kansteiner Feb 26, 2025 10:22am Piramal U.S. FDA Form 483 ...

Aurobindo Pharma's API facility in Hyderabad receives 10 observations from U.S. FDA, impacting parent company's stock price.

Dr. Reddy’s Laboratories active pharmaceutical ingredients (API) plant in Srikakulam, Andhra Pradesh, has been issued a Form 483 with four observations by the U.S. Food and Drug Administration.