US blocks imports from fourth Ranbaxy plant


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.


Related Content

Sun set on Ranbaxy rescue

9 April 2014 Business

news image

Acquiring beleaguered firm will create India’s biggest pharmaceutical company

Generic problems

22 November 2013 Premium contentFeature

news image

The Indian pharmaceutical industry has been hit by recent problems. Angeli Mehta investigates

Most Read

First pictures of hydrogen bonds unveiled

26 September 2013 Research

news image

Observation of intermolecular interactions in quinolines could help to settle the nature of this kind of bonding

Flowing rivers of mercury

7 January 2015 Feature

news image

Philip Ball investigates claims that the burial chamber of China’s first emperor contains rivers of shimmering mercury

Most Commented

Oh, the humanities!

20 April 2015 The Crucible

news image

Science and the arts are equally essential to society, says Philip Ball. Don’t divide them by their differences

Relativity behind mercury's liquidity

21 June 2013 Research

news image

First evidence that relativistic effects are indeed responsible for mercury's low melting point