FDA bans import of active ingredients from factory in Toansa, India
The US Food and Drug Administration (FDA) has banned Indian drugmaker Ranbaxy from importing active pharmaceutical ingredients produced at its plant at Toansa, India, into the US. The ban will remain in force until the company can prove that it has remedied its procedural failings and quality control issues.
This is the fourth Ranbaxy plant in India to fall under the ban, which cites failure to comply with Good Manufacturing Practice (GMP) requirements among other indictments. It follows increasing regulatory oversight of overseas manufacturing facilities by both European and US regulators, which has led to restrictions on several producers.
However, the company’s US manufacturing facilities are faring better, receiving approval to produce generic versions of the Alzheimer’s disease drug donepezil (Eisai and Pfizer’s Aricept) for distribution in Canada.
Ranbaxy is also aiming to produce generic versions of autoimmune disease antibody treatment infliximab (Johnson & Johnson’s Remicade) in India for the local market. The company has joined forces with Swiss firm Epirus, which is aiming to establish local production of infliximab and other biosimilar products in emerging markets. Epirus brings regulatory and manufacturing know-how, based on its proprietary Scale manufacturing platform for biosimilars, to enable its partner companies to produce complex biosimilars for their own regional markets.