News about Quality / GMP

Sun Pharma recalls more than 34,000 bottles of generic medication in US

The lot was manufactured at the Mumbai-based drugmaker's Halol-based manufacturing facility in Gujarat that has failed dissolution testing

Quality / GMP | 13/02/2023 | By Sudeep Soparkar |  895

Lupin bags US FDA approval for Glycopyrrolate injection

This is the first approval from Lupin’s injectable facility in Nagpur

Quality / GMP | 13/02/2023 | By Sudeep Soparkar |  572

Chennai-based Global Pharma Healthcare in radar for exporting contaminated eye drops

The company has exported two consignments of 24 batches of ‘Artificial Tears’ to the US which were manufactured in 2021 and 2022<br />

Quality / GMP | 06/02/2023 | By Sudeep Soparkar |  1061

US FDA completes inspection of Natco's Vizag formulation facility

The facility received two observations, one on the written production process control procedure and the other on the investigation procedure

Quality / GMP | 06/02/2023 | By Sudeep Soparkar |  1363

US FDA concludes inspection of Gland Pharma's Visakhapatnam facility with zero observations

The inspection was conducted at the company's API Facility at JNPC, Visakhapatnam, from January 23 to 27, 2023

Quality / GMP | 30/01/2023 | By Sudeep Soparkar |  931

US FDA places Glenmark Pharma's Baddi facility under import alert

The company will engage with the agency to resolve the import alert at the earliest

Quality / GMP | 27/01/2023 | By Sudeep Soparkar |  1154

Solara Active Pharma Sciences' Cuddalore facility completes WHO PQ inspection

The Cuddalore API site is a multi-product facility
<br />

Quality / GMP | 27/01/2023 | By Sudeep Soparkar |  1624

Torrent Pharma gets US FDA warning letter for Gujarat facility

The company said that this inspection classification will not have an impact on existing supplies or revenues from this facility

Quality / GMP | 25/01/2023 | By Sudeep Soparkar |  1840

US FDA inspects Indoco Remedies' solid oral formulation facility in Goa

The inspection was conducted from January 16 to 20, 2023

Quality / GMP | 24/01/2023 | By Sudeep Soparkar |  626

Strides Pharma completes WHO PQ inspection at Puducherry facility

The inspection was carried out between January 16-20, 2023

Quality / GMP | 23/01/2023 | By Sudeep Soparkar |  1168