Sanofi Active Ingredient Solutions API Supply, Custom Synthesis, API and Pharma Contract Manufacturing Solutions

Active pharmaceutical ingredients

Within the industrial affairs of Sanofi Active Ingredient Solutions is an organisation fully dedicated to third-party activities.

The mission of Sanofi Active Ingredient Solutions’ 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 around 200 intermediates and API through Sanofi Active Ingredient Solutions’ regular product list, which includes steroids, cobalamins, antibiotics, prostaglandins, opiates, opioids and fermentation derivatives.

The company’s commercial offer also includes a dedicated quality assurance (QA) and regulatory affairs support. Its manufacturing plants are frequently inspected by health authorities, with good manufacturing practice (GMP) customer audits being performed regularly.

Custom synthesis and API contract manufacturing

Sanofi Active Ingredient Solutions also provides custom synthesis and API contract manufacturing services, offering both toll manufacturing and customised synthesis of API ingredients, or multistep current good manufacturing practice (cGMP) intermediates.

Exclusive synthesis often concerns compounds that are still in the clinical development stage. Sanofi Active Ingredient Solutions offers customised services, working on process development to ensure:

  • Identification of industrial synthetic route, taking into account all of the parameters required for future industrialisation, such as existing patents, 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 chemistry, manufacturing, and control (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

Dedicated QA and regulatory affairs support is part of the Sanofi Active Ingredient Solutions offer.

Quality is one of the pillars of Sanofi Active Ingredient Solutions’ commercial strategy. The products it markets are manufactured in Sanofi facilities and all comply with the same high-quality standards as those applied for the Sanofi branded products.

The company’s manufacturing plants are frequently inspected by health authorities, including Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the US Food and Drug Administration (FDA), the Pharmaceuticals and Medical Devices Agency (PMDA), Korea Food and Drug Administration (KFDA) and the Brazilian Health Regulatory Agency (ANVISA).

Many GMP customer audits are performed regularly without any concern.

Sanofi Active Ingredient Solutions’ core 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

About Sanofi Active Ingredient Solutions

Sanofi Active Ingredient Solutions is the new branding of Sanofi API’s third-party business that was previously known as Sanofi CEPIA.

The company’s dedicated experts develop, manufacture and supply API and technological solutions. Through its catalogue of high-quality active ingredients and contract development and manufacturing services, the company delivers expertise and innovative, customised solutions that support customers in more than 80 countries worldwide.

Sanofi Active Ingredient Solutions’ products contribute to key therapeutic solutions that help millions of people. Its customers range from start-ups to big pharmaceutical companies.

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Press Release

Sanofi and NH TherAGuIX to Produce AGuIX® Nanoparticle in Oncology

AGuIX® is an innovative nanoparticle discovered by NH TherAGuIX, a French start-up based in Lyon and created in 2015 by Géraldine Le Duc and Olivier Tillement.

White Papers

SANOFI Active Ingredient Solutions

Sanofi Active Ingredient Solutions have more than 2,000 people developing, manufacturing and supplying active pharmaceutical ingredients and technological solutions to external customers and partners in 80 countries.

Address
Sanofi Active Ingredient Solutions

20, avenue Raymond Aron

92160 Antony Cedex

Ile-de-France

France

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

Sanofi Active Ingredient Solutions Images

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Press Release

19 February 2019

AGuIX® is an innovative nanoparticle discovered by NH TherAGuIX, a French start-up based in Lyon and created in 2015 by Géraldine Le Duc and Olivier Tillement.

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2 October 2018

Sanofi CEPiA has announced that the company will now be known as Sanofi Active Ingredient Solutions.

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10 May 2018

Sanofi has announced it will be attending a number of events this year.

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15 May 2017

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

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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 Active Ingredient Solutions

20, avenue Raymond Aron

92160 Antony Cedex

Ile-de-France

France

+33 1 55 71 26 34 +33 1 55 71 23 63 www.activeingredientsolutions-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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