Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time

USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam

The company will submit its comprehensive response on these observations to the US FDA

USFDA issues Form-483 for Lupin's Nagpur Unit-2

The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US

USFDA issues Form 483 for Parawada unit of Laurus Labs

The observation is procedural in nature and the company will address the observation within stipulated timelines.

Briefs: Indoco Remedies and Panacea Biotec

Panacea Biotec receives LoA from CMSS

Orbis India Partners Meet 2026 focuses on sustainable, climate-resilient eye care

Green Vision Centres cut emissions, expand community coverage as partners align on resilient eye health systems

APL Healthcare’s Unit-IV classified as VAI by the USFDA

This inspection is now closed

Lupin receives two observations from USFDA for Ankleshwar facility

The company will address the observations and respond to the U.S. FDA within the stipulated timeframe

Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility

Inspection included drug device combinations covering our recent filing in nasal sprays domain