News about Quality / GMP

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 |  1107

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 |  854

Strides Pharma's Bengaluru facility receives EIR from US FDA

The abbreviated Quality System Inspection Technique (QSIT) drug pre-approval on-site inspection was specifically conducted by the US FDA

Quality / GMP | 18/01/2023 | By Sudeep Soparkar |  817

Celadon Pharma's UK-based facility bags GMP registration by MHRA

Celadon's medicinal cannabis product will be supplied in oil form as an API

Quality / GMP | 17/01/2023 | By Sudeep Soparkar |  964

Lupin gets two observations from US FDA for Somerset facility

The inspection closed with the issuance of a Form-483 with two observations

Quality / GMP | 17/01/2023 | By Sudeep Soparkar |  730

Piramal Pharma's Lexington facility gets six observations from US FDA

The observations were classified under VAI (Voluntary Action Indicated) and do not relate to data integrity<br />

Quality / GMP | 17/01/2023 | By Sudeep Soparkar |  535

US FDA issues warning letter to Sun Pharma's Halol unit

Among other violations, the pharma major failed to thoroughly investigate any discrepancy or failure of a batch and failed to clean, maintain, sanitise, sterilise equipment and utensils at appropriate intervals

Quality / GMP | 17/01/2023 | By Sudeep Soparkar |  1040

Lupin, Exeltis bag reimbursement approval for NaMuscla in Spain

NaMuscla is Europe's first and only licensed product for this indication, and it will be commercialised in Spain by Lupin's partner Exeltis

Quality / GMP | 11/01/2023 | By Sudeep Soparkar |  921

Lupin receives US FDA approval for Fesoterodine Fumarate extended-release tabs

The product will be manufactured at Lupin’s facility in Goa

Quality / GMP | 09/01/2023 | By Sudeep Soparkar |  817

Gland Pharma's Dundigal facility gets EIR from US FDA

The US drug regulator inspected the facility from August 22 to August 25, 2022

Quality / GMP | 04/01/2023 | By Sudeep Soparkar |  951