News about Quality / GMP

Alembic Pharma receives EIR from US FDA for solid oral formulation facility at Jarod

The inspection carried out by them at our Solid Oral Formulation Facility (F-4) at Jarod, Vadodara during the period from December 6 to 16, 2022

Quality / GMP | 11/05/2023 | By Sudeep Soparkar |  1187

Nexus Pharmaceuticals receives FDA inspection of pharma manufacturing facility in Wisconsin

The Pleasant Prairie facility, which spans more than 84,000 square feet, is equipped with state-of-the-art isolator technology and adheres to the highest current good manufacturing practice (CGMP) standards

Quality / GMP | 08/05/2023 | By Sudeep Soparkar |  1226

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 |  1013

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 |  604

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 |  1699

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 |  2181

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 |  1067

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 |  998

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 |  902

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 |  985