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

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.

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

Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations

The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023

Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village

Aurobindo will respond to the US FDA within the stipulated timelines

Ipca Laboratories receives 8 observations from USFDA

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

Hikal announces USFDA audit with zero observations

This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites

Ipca Laboratories gets 3 observations for Piparia, Silvassa unit

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

Granules Consumer Health concludes FDA audit with zero observations

The audit is a pre-approval inspection for three products filed from the facility

Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit

The observations are procedural in nature