Dispatches from CPhI

Novasep granted US FDA approval at two EU API facilities

Novasep receives US FDA approval at two EU API sites

French CMO Novasep has received the thumbs up from US regulators at two of its European API manufacturing facilities.

Novasep’s site in Le Mans, France manufactures highly potent active pharmaceutical ingredients (HPAPI) and antibody drug conjugate (ADC) payloads, whilst the plant in Leverkusen, Germany, makes formulated nitroglycerine.

Talking with Director of Marketing, Sophie Baudouin, at CPhI in Frankfurt last week, Outsourcing-Pharma.com learned Novasep “had two audits within a month” from the US Food and Drug Administration (FDA) which proved successful in meeting US standards.

Regarding the Leverkusen facility, “hazardous chemistry is a speciality of [the] site and is used to produce formulated nitroglycerine," used in cardiovascular treatments, she added.

As for Le Mans, the “audit related to paclitaxel which is an API well known for years to treat cancer. The brand name used to be Taxol from BMS but now it’s a generic API” and Novasep has held FDA drug master file (DMF) since 1996, she said. “It’s not an extension but a preapproval audit” for the cancer API, she added.


Le Mans was subject to a €3m ($4.1m) expansion in 2012 in order to offer customers ADC capabilities, with HPLC chromatography and drying to support commercial scale production.

Amongst the recent CMO investors in ADC capacity (SAFC and Carbogen Amcis this month alone), Novasep is a relative veteran. Baudouin told us the facility was able to “handle very highly potent products which perfectly fit with the payloads for ADC.

“With ADCs, the most successful ones are the ones that have very efficient payloads, so the competitive advantage is being able to handle this very toxic very potent product.”

Awaiting Audit for Amarin

These two facilities may have passed FDA inspection but Novasep, through its subsidiary Finorga, is still awaiting an audit at its Mourenx, France, API facility, to manufacture Vascepa for Irish drugmaker Amarin.

Amarin asked the FDA to approve the site, currently being built, in order to bring the number of Vascepa API suppliers to four, with Nisshin Pharma, BASF and Chemport being the others.

A spokesperson for Novasep, told this publication the facility is on track and, is set to “supply Vascepa API to Amarin starting in 2014.”

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