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Home / About Novasep / Media & Events / Press releases / Three Novasep custom manufacturing sites renew FDA approval in 2016

Three Novasep custom manufacturing sites renew FDA approval in 2016

Three Novasep custom manufacturing sites renew FDA approval in 2016
20 Dec 2016

Successful FDA inspections confirm Novasep’s longstanding reputation in maintaining
quality assurance systems fully compliant with the highest world standards

Lyon, France, December 20, 2016 – Novasep, a leading supplier of services and technologies for
the life sciences industry, today announces that three of its custom manufacturing sites individually
passed the general inspection process of the US Food and Drug Administration (FDA) free of any
483 form.

All three FDA general inspections have taken place at Novasep’s manufacturing sites in France
(Mourenx and Le Mans), and in Germany (Leverkusen) over the course of 2016.

Novasep’s manufacturing site in Le Mans, France, produces highly potent cytotoxic active
pharmaceutical ingredients (HPAPI) and registered advanced intermediates for commercial or
clinical development use. The site also provides customers with regulatory and containment
evaluation support. It produces paclitaxel, for which Novasep holds a valid Drug Master File and a
European CEP (Certificate of Suitability). The site is also renowned for Antibody Drug Conjugate
(ADC) payload production services that will soon be extended to ADC conjugation.

The manufacturing site in Mourenx, France, produces APIs and advanced intermediates.

Novasep’s site in Leverkusen, Germany, amongst its set of technical expertise, can handle
hazardous chemicals at industrial scale. This know-how is particularly suitable for designing
shorter, cost-effective synthetic routes for producing APIs and advanced intermediates. The site
also produces and sells pre-formulated nitroglycerin products for the pharmaceutical market.

In each case, the FDA inspection confirmed that commercial APIs produced at each site are
suitable for drugs marketed in the US.

This success has been made possible by the day-to-day good practices adopted by every
colleague involved in operations. The robust system implemented by Novasep’s quality assurance
team ensures these high standards,” said Jean-Claude Romain, VP quality at Novasep. “These
three successful inspections reward this long-term teamwork and commitment.”

Global professional juries have recognized Novasep several times for the reliability and the
robustness of its quality system.


About Novasep
Novasep is a global provider of cost-effective and sustainable manufacturing solutions for life
sciences molecules and fine chemicals. Novasep's unique offering includes process development
services, purification equipment and turnkey processes, contract manufacturing services and
complex active molecules to serve pharmaceutical, biopharmaceutical, fine chemical, food and
functional ingredients as well as fermentation and chemical commodities industries.

Andrew Lloyd & Associates
Carol Leslie
UK and US: +44 1273 675 100
France: +33 1 56 54 07 00

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