Novasep Passes FDA Inspections on Two Sites
PTSM: Pharmaceutical Technology Sourcing and Management
Novasep gains approval from FDA to produce new molecular entity for US market.
Novasep has successfully completed FDA pre-approval inspections carried out at two of its sites in France. Novasep is now an authorized producer of a new molecular entity already approved in the US. The inspection concerned a multi-site project Novasep manages for synthesizing and purifying a kinase inhibitor active ingredient.
The FDA inspections took place during June 2014 at Novasep’s Chasse-sur-Rhone and Pompey sites in France. The Chasse-sur-Rhone site is responsible for the synthesis of late stage intermediates and API, while the Pompey site takes charge of the last purification step.
Source: Novasep
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
