News about Quality / GMP

Indoco receives EIR for its manufacturing facility in Goa

Indoco expects the change in compliance status to pave the way for approvals of ANDAs submitted from this site

Quality / GMP | 04/05/2023 | By Sudeep Soparkar |  999

Biocon Biologics mAbs facility bags EU GMP Certification for bBevacizumab

The approval reflects Biocon Biologics’ compliance with the highest international regulatory standards

Quality / GMP | 02/05/2023 | By Sudeep Soparkar |  586

Kwality Pharmaceuticals' HP facility bags EU GMP approval

The GMP inspection of the site was conducted between April 18 to April 22, 2023

Quality / GMP | 25/04/2023 | By Sudeep Soparkar |  1662

Cadila Pharma facility in Dholka passes US FDA audit

US FDA Inspector Vivin George conducted the facility’s audit from April 3 to 7

Quality / GMP | 20/04/2023 | By Sudeep Soparkar |  2088

Zydus receives final approval from US FDA for Estradiol Transdermal System

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (US FDA) to manufacture and market Estradiol Transdermal System USP, 0.014 mg/day (weekly) (USRLD: Menostar® Transdermal System).

Quality / GMP | 19/04/2023 | By Sudeep Soparkar |  1026

Piramal Pharma gets EIR from US FDA for Sellersville, USA facility

The inspection has now been successfully closed by the US FDA

Quality / GMP | 19/04/2023 | By Sudeep Soparkar |  984

Zydus receives US FDA approval for Tavaborole Topical Solution, 5%

The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad

Quality / GMP | 13/04/2023 | By Sudeep Soparkar |  891

Granules Consumer Health completes US FDA audit with zero 483s

The packaging facility in Manassas is spread over 79,000 sq ft

Quality / GMP | 22/03/2023 | By Sudeep Soparkar |  969

Bliss GVS Pharma gets three minor observations from US FDA for Palghar unit

The company will prepare a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines

Quality / GMP | 20/03/2023 | By Sudeep Soparkar |  1488

US FDA conducts Pre-Approval Inspection of oral oncology manufacturing facility in Gujarat

The company has been issued a Form 483 with 1 observation, which is procedural

Quality / GMP | 20/03/2023 | By Sudeep Soparkar |  874