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FOCUS ON
- June 2010
Isochem’s Vitamin E TPGS (Vitamin E, D-alpha-tocopheryl
polyethylene glycol 1000 succinate) last updates:
- Drug master files (DMF type II) filed with the US Food and
Drug Administration (FDA)
- GMP certificate from AFSSAPS
Following the certificate of GMP compliance that Isochem was granted for by the Drug French Authority, AFSSAPS (Agence Française de
Sécurité Sanitaire des Produits de Santé) in September 2009, ISOCHEM has filed at the FDA on May 19, 2010 and in CTD format, a DMF type II for Vitamin E TPGS. Isochem’s customers may from now on benefit from Isochem’s technological confidential property information contained in the open part and the entire DMF file to include it into their marketing authorisation application dossier.
This filing comes as a continuation of Isochem’s constant efforts to deliver high standard of services to its customers. Beyond the delivery of a high quality Vitamin E TPGS, Isochem’s primary objective is to provide relevant technical competence and capability in custom synthesis, and regulatory support to its clients to serve their innovation.
Vitamin E TPGS is a multi-task excipient used in the pharmaceutical and nutraceutical fields. Vitamin E TPGS has shown proven and recognized utility to improve bioavailability of poorly absorbed drugs acting as a solubilizer and as an absorption and permeability enhancer. As a water soluble compound, Vitamin E TPGS is also used as an efficient source of Vitamin E, for therapeutic purposes and in the food industry.
With 3 c’GMP approved production sites Isochem serve various international customers strengthening its position as a key partner of major actors in the pharmaceutical markets.
- April 2010
Dear Client
We are delighted to inform you that ISOCHEM S.A. has been successfully
acquired by AURELIUS Group on March 31, 2010. This closing follows a share
capital sale agreement signed between SNPE GROUP and AURELIUS AG
on 22 February 2010. The final closing encompasses the whole of ISOCHEM S.A.
and its subsidaries, exisiting operations and personnel including the Hungarian
facility FRAMOCHEM.
The finalisation of these negotiation provides a challenging and dynamic
opportunity for ISOCHEM Group to expand it's future activities.
Our operational organization and your current contacts within ISOCHEM
remain unchanged.
-
Oct 2009: Chemistry Today
- Growing challenges of API process development
in custom
manufacturing - Yves Robin,Catherine Mercier.
(Download
PDF file)
- October 2009: Isochem
receives a GMP certificate from AFSSAPS for
Vitamin E TPGS (Vitamin E, D-alpha-tocopheryl
polyethylene glycol 1000
succinate)
manufacture
Isochem
was granted a GMP compliance certificate for Vitamin
E TPGS
production
by the Drug French Authorities, AFSSAPS (Agence Française
de
Sécurité
Sanitaire des Produits de Santé). The GMP certificate
granted after an
audit
in Gennevilliers, France during July 2009 reflects the
merit of the company’s
good
manufacturing practices and guarantees value to Isochem’s
customers
who
rely on high quality Vitamin E TPGS.
Vitamin
E TPGS is a multi-task excipient used in nutraceutical
and pharmaceutical
fields.
It has proved its acknowledged utility to improve the
bioavailability of poorly
absorbed
drugs acting as a solubilizer, absorption and permeability
enhancer.
As
a water soluble compound, Vitamin E TPGS is also used
as an efficient source
of
Vitamin E, for therapeutic purposes and in the food
industry.
Over
the last two years Isochem has manufactured large quantities
of Vitamin E
TPGS
for customers worldwide thus strengthening its position
as a key partner of
the pharmaceutical market’s major actors.
- ISOCHEM invests at its
Vert-le-Petit site
The
ISOCHEM Vert-le-Petit site is a GMP site, specialized
in phosgenation,
amino
acid and peptide chemistry. It groups R&D forces and
ISOCHEM’s main
pilot
workshop. The c-GMP investment underway at the Vert-Le-Petit
pilot plant
will
equip the site with a controlled atmosphere clean room
(class 10,000)
as
well as airlocks for product, for equipment and staff,
and a washing facility
for
small equipment. ISOCHEM thus equips its pilot workshop
with a
state-of-the-art
environment for the routine production of active pharmaceutical
ingredients
(API).ISOCHEM also plans to be audited by the FDA before
the end
of
2010. This represents a nearly 600 K€ investment.
ARCHIVES
2010 EXHIBITIONS & EVENTS
| Village de la Chimie Parc
Floral de Paris (Vincennes) |
12-13 February |
n°- |
| INFORMEX
San Francisco (USA) |
16+17-19
February |
n°1028 |
| CPhI EUROPE Paris Nord Villepinte (France) |
5-7 October |
Hall 6 / n° 6K28 |
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| New pilot facility in Vert-le-petit |
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