Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility

The United States Food & Drug Administration (USFDA) today completed a GMP inspection at Dr. Reddy's Laboratories Limited's API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. The inspection was conducted from May 30, 2024 to June 7, 2024. The company has been issued a Form 483 with four observations, which we will address within the stipulated timeline.

Ami Organics' Unit I, Sachin, Surat cleared PMDA Japan, GMP inspection

Ami Organics Limited's manufacturing facility, Unit I situated at Sachin, Surat which is involved in manufacturing of various intermediates for Active Pharmaceuticals Ingredients, has undergone a Good Manufacturing Practices (GMP) inspection by Pharmaceutical and Medical Devices Agency, Japan (PMDA) starting June 4, 2024. The inspection has concluded successfully on June 7, 2024 without any critical/major observation.