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.

ADCs

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.”

Related News

Novasep to keep supplying Amarin with Vascepa API

Novasep to keep supplying Amarin with Vascepa API

Encap says more firms are using HPAPIs

Encap selected to formulate Lipocine's HPAPI oral testosterone

Patheon upgrades UK facility due to HPAPI demand

Demand for HPAPIs drives Patheon to invest $1m in UK facility

Novasep riding on downstream tech and services in 2013

Continuous chromatography tech part of 'facility of the future,' says Novasep

Novasep's Chasse-sur-Rhone, France site will produce the API

USFDA approves Novasep facilities for kinase inhibitor contract

Paclitaxel could be used to treat bile duct cancer

Bile duct cancer breakthrough will not stretch paclitaxel supplies says analyst

Dynamite for cancer treatment? Nitroglycerin can improve chemotherapy say researchers

Cure not kill: Dynamite ingredient can improve cancer treatment says study

Novasep’s HPAPI plant gets SafeBridge certification

Going Up? People on the Move

People: Waters' CEO to Step Down; Novasep Welcomes CFO

Key Drugmaking Reagent Burns Like Gunpowder Warns Novasep

Key Drugmaking Reagent As Inflammable as Gunpowder Warns Novasep

Novasep invests in French API production

Novasep to invest €30m in large-scale API production plant

Amarin Asks FDA to OK Novasep as Vascepa Supplier

Amarin Asks US FDA to OK Novasep as Vascepa API Supplier