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

US import ban imposed on Indian pharma firm

16 July 2015 Business

news image

Concerns over manufacturing processes at Emcure facility prompts Food and Drug Administration to block drug shipments

Most Read

Flushing advice is flawed

24 August 2015 Research

news image

Protocols to restore contaminated water supplies are not based on science

Simple chemistry saving thousands of gold miners from mercury poisoning

25 August 2015 News and Analysis

news image

Basic apparatus is cutting mercury pollution and helping Indonesian miners go for gold

Most Commented

A risky business

28 August 2015 In the Pipeline

news image

Graduate research is likely the most risky time of a chemist’s career, says Derek Lowe

Exploiting the data mine

13 August 2015 Feature

news image

Chemists must embrace open data to allow us to collectively get the best out of the masses of new knowledge we unearth, repor...