US FDA pulls 27 ANDAs for drugs made at banned Ranbaxy plants

By Gareth Macdonald

- Last updated on GMT

US FDA pulls 27 ANDAs for drugs made at banned Ranbaxy plants

Related tags: Consent decree, Food and drug administration, Pharmaceutical drug

Ranbaxy has asked the US FDA to withdraw 27 ANDAs for products previously made at Indian manufacturing facilities hit with consent decree earlier this year.

The Indian firm told the Bombay Stock Exchange​ (BSE) the ANDAs in question “do not pertain to current business and will have a negligible impact on…business in USA,”​ adding that the withdrawal will allow it to focus on applications that are of “greater importance​.”

The withdrawal – detailed in the US Federal Register​ – is the latest stage in Ranbaxy’s efforts to address quality problems at its plants in Dewas, Batamandi and Paonta, which have been the subject of a US Food and Drug Administration (FDA) import ban since 2008​.

In the years since, Ranbaxy has both accused rival pharmaceutical companies of mudslinging​ and faced accusations of submitting falsified data​ to the FDA in an increasingly acrimonious dispute, which culminated in the firm’s receipt of a consent decree​ in January this year.

Under the decree Ranbaxay was required to stop distributing drugs made at the plants, hire third-party reviews to assess operations, adopt strict data integrity policies and withdraw any applications that contained untrue statements.

At the time CEO Arun Sawhney said: “We are pleased with the progress we have made in upgrading and enhancing the quality of our business and manufacturing processes and remain committed to ensuring that all of our facilities and products meet the high standards that patients, prescribers and the public have come to expect from Ranbaxy​.” 

Related topics: Markets & Regulations, QA/QC, Regulations

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