Drug and ingredient maker Eisai has entered into a strategic partnership and ingredient supply deal aimed at expanding and growing fellow Japanese firm Nichi-Iko Pharmaceutical’s generic pharmaceutical business.
The deal will see active pharmaceutical ingredients (APIs) produced from Eisai’s site in Visakhapatnam (Vizag), Andhra Pradesh, India.
Eisai already supplies APIs to Japan for generic makers using the Vizag plant, spokesperson Yasuko Minamida told this publication, and will now begin providing APIs to Nichi-Iko based on this collaboration.
“First item will be epalrestat API, a carboxylic acid derivative which inhibits aldose reductase,” we were told.
The ingredient is formulated for drugs to treat diabetic neuropathy, a common long-term complications in patients with diabetes mellitus. “Eisai will supply it to Nichi-Iko in the fourth quarter of fiscal 2018.”
The Vizag site comprises 14 individual buildings across 33 acres, including an API lab, an API building, a drug substance facility, a drug product facility and a QA/QC research lab. Since its completion in 2009, the firm has invested over $20m in expansions and it now boasts annual production capacity to 60t of formulations and two billion tablets.
It is also fulfils Eisai’s ‘high quality price competitive API’ strategy, which according to Minamida fulfils the growing demand for generic API in a tightly-regulated Japanese market.
“Maximizing the use of the various functions at the core of the Vizag plant, including research and development, manufacturing, quality management and auditing, we will achieve the supply of high quality price competitive API.”
Total Inclusive Ecosystem
Under terms of the deal, all shares of Eisai subsidiary Elmed Eisai will be transferred to Nichi-Iko and a new business model – called ‘Eisai's Total Inclusive Ecosystem’ – will be set up.
This will allow Eisai to deliver various solutions to address patients’ needs in specific areas with its partners, Minamida said.
“Through the collaboration with Nichi-Iko, who has a wide range of generic pharmaceuticals, we have gained the ability to provide more comprehensive solutions.”