News|Articles|July 22, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

  • PTSM: Pharmaceutical Technology Sourcing and Management-08-06-2014
  • Volume 10
  • Issue 8

Novasep Passes FDA Inspections on Two Sites

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


Related to this article

PharmTech Weekly Roundup—October 2, 2026
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
CPHI Milan 2026: Nitrosamine Risk Mitigation, Part 1
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
Regulatory Roundup—September 2026
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.