Tag: Gland Pharma Form 483 observations

Gland Pharma’s Visakhapatnam facility gets 3 observations after USFDA inspection – CNBC TV18

[ad_1] Gland Pharma Ltd on Tuesday (February 25) announced that America’s drug regulatory watchdog has completed a crucial inspection of its Andhra Pradesh facility. Company Value Change %Change In a regulatory filing, Gland Pharma said, “…the United States Food and Drug Administration (USFDA) has conducted a pre-approval inspection (PAI) for Sterile APIs at the company’s […]

US FDA issues Form 483 with 3 observations for Gland Pharma’s Hyderabad facility – CNBC TV18

[ad_1] Hyderabad-based pharmaceutical company Gland Pharma Ltd on Friday (August 2) said the United States Food and Drug Administration (US FDA) conducted an unannounced inspection of its Pashamylaram facility in Hyderabad between July 25, 2024, and August 2, 2024, to assess Good Manufacturing Practices (GMP). “This is to inform you that the United States Food […]

Back To Top
Translate »