Mfg News: Novartis, Aurobindo Pharma, & Sun Pharma
A roundup of manufacturing news from Novartis, Aurobindo Pharma, and Sun Pharma. Highlights below.
Novartis Suspends Mfg of Two Radioligand Drugs
Novartis has temporarily suspended production of two radioligand drugs, Lutathera (lutetium Lu 177 dotatate) and Pluvicto (lutetium Lu 177 vipivotide tetraxetan), at its production sites in Ivrea, Italy, and Millburn, New Jersey, due to potential quality issues identified in its manufacturing processes.
As a result, the company is temporarily suspending delivery of Lutathera in the US and Canada, and Pluvicto in the US. Some doses of Lutatherawill be available in Europe and Asia from Novartis’ radioligand therapy production site in Zaragoza, Spain, although the company says there may be some delays in supply.
Novartis is conducting a review of the situation and expects to resolve the issues and resume some supply in the next six weeks (as reported on May 5, 2022). In addition, Novartis is putting a temporary hold on screening and enrollment of clinical trials for Pluvicto globally, and Lutathera clinical trials in the US and Canada.
FDA Cites Aurobindo Pharma’s Oral Dose Mfg Facility
Aurobindo Pharma, a Hyderabad, India-based a manufacturer of generic pharmaceuticals and a contract manufacturer, reports that the US Food and Drug Administration (FDA) has issued six observations in a Form 483 after concluding an inspection of the company’s oral dose manufacturing facility in Jedcherla, Hyderabad, India.
The inspection was carried out between May 2, 2022 and May 10, 2022. The company says it will respond to the FDA within the stipulated timeline and work closely with the agency to close the observations.
Source: Aurobindo Pharma
FDA Cites Sun Pharma’s Mfg Facility
The US Food and Drug Administration (FDA) has issued 10 observations in a Form 483 after concluding an inspection at Sun Pharmaceutical Industries’ manufacturing facility in Halol, Gujarat, India.
The inspection was carried out between April 29, 2022 and May 9, 2022. The company says it is preparing its response to the observations, which will be submitted to the FDA within 15 business days (as reported on May 10, 2022).
Source: Sun Pharma