News about Quality / GMP

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 |  1031

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 |  1333

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 |  917

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 |  1122

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 |  1559

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 |  1381

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 |  621

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 |  1120

Stelis Biopharma's facility receives EIR from US FDA

The company received the EIR from USFDA for the drug-device combination to be commercialised from the company's flagship facility in Bengaluru<br />

Quality / GMP | 20/01/2023 | By Sudeep Soparkar |  1093

Switzerland, US in agreement on pharma GMP

Under the agreement, both countries will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections

Quality / GMP | 19/01/2023 | By Sudeep Soparkar |  837