News about Quality / GMP

GEODIS Strengthens Pharma Capabilities in the Americas With Seven IATA CEIV Pharma Certifications

GEODIS, a world leader in transport and logistics, announced today it has strengthened its air freight temperature-controlled pharma shipment capabilities across the Americas region by earning IATA's Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) certification across seven sites in the United States.

Quality / GMP | 08/06/2023 | By Sudeep Soparkar |  593

Intas gets USFDA Import Alert but allowed to supply 24 critical drugs

Intas Pharmaceuticals Limited has informed that its manufacturing facility SEZ (Pharmez) near Ahmedabad has been listed under ‘Import Alert’ by the US Food and Drug Administration (USFDA).

Quality / GMP | 06/06/2023 | By Sudeep Soparkar |  1068

Indoco Remedies Ltd's Sterlie Facility at Goa receives Form 483 with 4 observations from USFDA

The United States Food and Drug Administration (USFDA) had inspected Indoco Remedies Limited's Sterile Facility (Plant II) located at Goa("Facility"), from February 20, 2023 to February 28, 2023.

Quality / GMP | 06/06/2023 | By Sudeep Soparkar |  833

Lupin receives approval from U.S. FDA for Diazepam Rectal Gel

Global pharma major Lupin Limited (Lupin) today announced that its wholly-owned subsidiary, Novel Laboratories Inc., based in Somerset, New Jersey, has received approval from the United States Food and Drug Administration (U.S. FDA)

Quality / GMP | 02/06/2023 | By Sudeep Soparkar |  795

US FDA inspection completed at Caplin Steriles Injectable site at Gummidipoondi

Caplin Point Laboratories Limited has announced that the United States Food and Drug Administration (USFDA) had completed its GMP and PAI inspection of Caplin Steriles Limited's (a subsidiary of Caplin Point Laboratories Limited) Sterile Injectable site at Gummidipoondi between May 22nd to 31st.

Quality / GMP | 02/06/2023 | By Sudeep Soparkar |  1275

Belgium's UCB Pharma hit with FDA Form 483 after April inspection

UCB Pharma, a Belgium-based biopharma company, has been slapped with a Form 483 from the FDA following an inspection that uncovered issues with its quality control unit and product storage.

Quality / GMP | 31/05/2023 | By Sudeep Soparkar |  687

USFDA Inspects Aurobindo Pharma's API Unit, Issues 'Form 483' With Four Observations

On 19 May, Aurobindo Pharma's Unit XIV, an API Non-antibiotic Manufacturing facility situated at Paravada Industrial Area, Anakapalli District got inspected by the United States Food and Drug Administration (USFDA) from 15th May to 19th May 2023, the company stated in an exchange filing on Friday.

Quality / GMP | 23/05/2023 | By Sudeep Soparkar |  778

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 |  1057

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 |  1125

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 |  963