January 26, 2012
Eisai India Plant (EPM) was established in Andhra Pradesh, India in December, 2009. EPM is a high-quality and low-cost manufacturing facility with high cost-competitiveness, supplying medicinal products mainly to emerging and developing countries. There is a formulation research laboratory, as well as manufacturing facilities for drug substance (active ingredients) and medicinal products. Eisai products manufactured at the Eisai India Plant are already distributed within India and released to Japan. GMP audits, training and technology transfers are currently ongoing, as it is intended for this plant to also supply products to developed world markets, including those of the USA, Europe and Japan. Eisai India Plant has already been inspected by the US regulatory authority (FDA) for GMP compliance and received US FDA approval as an additional manufacturing site of Aricept, an Alzheimer's disease treatment.
Information (15th December, 2011)
Eisai's Indian Manufacturing Base Receives Approval from US FDA to Manufac Alzheimer's Disease Treatment Aricept
Eisai India Plant also houses the Procurement Strategy Unit where raw material vendors which can supply high quality materials are selected from India for all over the world. A guideline for global selection of raw material vendors is being prepared.
By fully utilizing the potential of the Eisai India Plant with its cost-competitiveness, Eisai wishes to contribute to access to medicines around the world, by realizing affordable pricing with more products.
It is also planned that the Eisai India Plant will be the manufacturing site of the 2.2 billion DEC tablets containing diethylcarbamazine citrate, an anti-filarial medication which will be provided to WHO “at price zero” over seven years. Development of the manufacturing process is currently ongoing. The DEC tablets manufactured at the Eisai India Plant are planned to be distributed in 37 countries. They will be manufactured under the same facility and the same GMP conditions as those for the US/EU market products and high-quality products will be stably manufactured in accordance with the manufacturing plan. As many Eisai India staff are familiar with this very devastating disease, they take great pride and motivation in being directly engaged in manufacturing DEC tablets provided to WHO.
For further details of the DEC Provision Program for WHO, please see “Status of DEC Provision Program for WHO” via the link below.