Sanofi CEPiA API Supply, Custom Synthesis, API and Pharma Contract Manufacturing Solutions

Active pharmaceutical ingredients

Within the industrial affairs of Sanofi, CEPiA (Commercial and External Partnership, Industrial Affairs) is an organisation fully dedicated to third-party activities.

The mission of the CEPiA sales activity is to promote the use of Sanofi’s industrial network for active pharmaceutical ingredients (API) sales and custom synthesis.

Supply of intermediates and active pharmaceutical ingredients

Sanofi has high-performance quality units, including 16 chemistry, biochemistry and biotechnical facilities, for the production of high-quality APIs and advanced intermediates.

Sanofi manufactures and offers through CEPiA a regular product list (about 200 intermediates and APIs), including:

  • Steroids
  • Cobalamins
  • Antibiotics
  • Prostaglandins
  • Opiates
  • Opioids
  • Fermentation derivatives

CEPiA’s commercial offer also includes a dedicated quality assurance and regulatory affairs support. Our manufacturing plants are frequently inspected by health authorities, with GMP customer audits being performed regularly.

Custom synthesis and API contract manufacturing

CEPiA also provides custom synthesis and API contract manufacturing services, offering both toll manufacturing and tailor-made synthesis of API ingredients, or multistep cGMP intermediates.

Exclusive synthesis often concerns compounds that are still in the clinical development stage. CEPiA offers tailored services, working on process development for ensuring:

  • Identification of industrial synthetic route, taking into account all of the parameters required for future industrialisation, such as existing patents, HSE, quality and cost
  • Process optimisation
  • Physical quality studies
  • Process safety studies
  • Process chemical engineering studies
  • Scaling-up with the production of batches in pilot workshops, including technical, clinical, primary stability and registration
  • Development and validation of analytical methods
  • Necessary regulatory support for drafting the CMC sections of the dossiers

Toll manufacturing commonly involves molecules that are pending registration or those that have already been marketed. After the transfer of your manufacturing process, toll manufacturing can be applied, in accordance with the specifications provided, without modification of the necessary quantities. Alterations to the process will only be made with your consent.

Quality assurance and regulatory affairs support

A dedicated quality assurance and regulatory affairs support is part of the CEPiA offer.

Quality is one of the pillars of the CEPiA commercial strategy. The products we market are manufactured in Sanofi facilities and all comply with the same high-quality standards as those applied for the Sanofi branded products.

All our manufacturing plants are frequently inspected by health authorities (ANSM, FDA, PMDA, KFDA, ANVISA, etc.) and many GMP customer audits are performed regularly without any concern.

Our core are of expertise includes:

  • Corticosteroids
  • Hormones
  • Multi-steps chemistry
  • Opiates and opïoids
  • Prostaglandins
  • High active products (taxanes)
  • Oligosaccharides
  • Peptides
  • Oligonucleotides
  • Biotechnologies
  • Therapeutic proteins
  • Monoclonal antibodies
  • Viral vectors
  • Plasmids

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Press Release

Upcoming Events Sanofi CEPiA

Sanofi CEPiA has announced a number of upcoming events where the company will be showcasing its products and services.

White Papers

CEPiA White Papers: Production of Biologics Expression Systems

Within Sanofi Industrial Affairs, we can offer external partners looking for a CDMO / CMO (contract dupt and manufacturing organisation / contract manufacturing organisation) the excellence of our industrial network to produce custom APIs.

Address
Sanofi CEPiA

20, avenue Raymond Aron

92160 Antony Cedex

Ile-de-France

France

+33 1 55 71 26 34 +33 1 55 71 23 63 www.cepia-sanofi.com

Sanofi CEPiA Images

Products and Services

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Press Release

15 May 2017

Sanofi CEPiA has announced a number of upcoming events where the company will be showcasing its products and services.

Read more
19 October 2016

Sanofi has experience with industrial development of all kinds of projects and brings new chemical entities to market.

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19 April 2016

The Life Science Leader magazine has awarded CEPiA-Sanofi as a worldwide CMO Leader for the third year running.

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12 April 2015

CEPIA-Sanofi has been awarded the CMO leadership award within the categories quality, reliability, productivity and innovation by Life Science Leader.

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Regional Offices

Sanofi CEPiA

20, avenue Raymond Aron

92160 Antony Cedex

Ile-de-France

France

+33 1 55 71 26 34 +33 1 55 71 23 63 www.cepia-sanofi.com
CEPiA US and Canada

55 Corporate Drive

08807 Bridgewater

New Jersey

United States of America

+1 908 981 4986
CEPiA Japan

20-2, Nishishinjuku 3-chome

Shinjuku

163-1488 Tokyo

Japan

+81 3 6301 3450
CEPiA Eastern Europe and Turkey

Nitrianska 100

920 27 Hlohovec

Slovakia

+421 33 736 2810
CEPiA India

Aventis House

54/A, Sir Mathuradas Vasanji

400 093 Mumbai

Maharashtra

India

+91 22 28278089
CEPiA China

Floor 30, Phase II, Plaza 66, No.1366 Nanjing

200040 Shanghai

China

+86 21 6288 1616 (Ext. 2804)
CEPiA Eastern Europe and Turkey

130 U Kabelovny

PRAGUE 10

102 37

Prague

Czech Republic

CEPiA China

Kerry Center Tower 3

20F, 1228 Yan’An Road

Jing An District

200040

Shanghai

China

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