Sanofi. As part of its growth strategy in diabetes, Sanofi’s Frankfurt, Germany site, its principal manufacturing center for diabetes
products, is being equipped with a new aseptic processing area that uses isolator technology to improve the aseptic-filling
process. This investment will be operational in 2016. Sanofi’s Frankfurt site is one of three dedicated biotechnology hubs
that the company is developing in Europe. In 2012, its facility in Vitry-sur-Seine, France, the company’s largest integrated
cell-culture facility, produced the first technical batches of aflibercept, the API in the company’s anticancer drug Zaltrap.
Its facility in Lyon Gerland, France, is a new world center dedicated to the production of thymoglobulin, a drug to prevent
and treat transplant rejection. During 2012, teams at Lyon prepared a dossier for the healthcare authorities as part of the
process of transferring production to this site.
Table I: Top 50 pharmaceutical companies (Rankings 26-50)
In the United States, Sanofi, through its subsidiary Genzyme, has major investments underway, including at its Framingham,
Massachusetts biologics site, which was approved by FDA and EMA in 2012 for the manufacture of Fabrazyme (agalsidase beta)
to treat Fabry disease. Its site at Allston, Massachusetts moved forward with a major investment program in connection with
the implementation of a compliance-remediation workplan approved by FDA in January 2012. Also, in 2012, Sanofi’s Genzyme acquired
the Bayer Healthcare facility in Lynnwood, Washington, which specializes in the manufacture of Leukine (sargramostim).
On the vaccine side, Sanofi Pasteur, the company’s vaccine arm, is undergoing a major investment phase, which includes a new
dedicated dengue fever vaccine facility in Neuville, France scheduled to produce its first batches in 2014. In response to
observations made by FDA during routine inspections conducted in 2012 at Sanofi’s facilities in Toronto and Marcy l’Etoile,
France, Sanofi Pasteur initiated a compliance program to address quality issues.
Sanofi is moving forward with other investments in emerging markets. Two new dedicated influenza vaccine-manufacturing facilities
are in the start-up phase. Sanofi’s facility in Shenzhen, China is testing its production processes, and its facility in Ocoyoacac,
Mexico was approved by Mexican regulatory authorities at the start of 2012 and began production in time for the Mexican influenza
vaccination program in September 2012.
The Sanofi diabetes industrial network also is expanding its manufacturing footprint in emerging markets in Russia as well
as in China (Beijing), where a new facility that was inaugurated in 2012 began assembly and packaging of SoloSTAR, the prefilled
injection system for Lantus (insulin glargine). Also, during 2012, Sanofi’s pharma site in Ankleshwar, Gujarat State, India,
handled packaging and quality control through to release for the first commercial batches of AllSTAR, the company’s insulin
pen specifically intended for the India market.
Earlier this year, Sanofi began construction for a new $75-million manufacturing in Saigon, Vietnam. The plant, which is scheduled
to be operational by the end of 2015, will have an initial capacity of 90 million units per year with a possible extension
up to 150 million units. In the Middle East, Sanofi is investing in a new solid-dosage manufacturing facility in Saudi Arabia;
products from the facility are expected in 2015. The company is also investing in a new hormonal- products facility in Brasilia,
Brazil. The company’s Goa site in India expanded solid dosage production capacity to approximately 2.5 billion pills a year.
And in Algeria, Sanofi signed an agreement with the local authorities for a major industrial investment that will lead to
the construction of a large industrial complex in the Africa-Middle East region.