US bans drugs and all but one API made at three IPCA Labs plants

By Gareth Macdonald contact

- Last updated on GMT

iStock/daboost
iStock/daboost

Related tags: Federal food drug and cosmetic act, Food and drug administration

The US FDA has banned all drugs and all but one of the APIs made by Ipca Laboratories at its facilities in Ratlam, Indore and Piparia.

The Indian firm announced the ban in a series of Bombay Stock Exchange (BSE) filings last week (here​, here​ and here​).

All three facilities have been the subject of US Food and Drug Administration (FDA) concern for several years.

In 2014​, the US agency issued IPCA with a Form 483 detailing an unspecified number of observations made during an inspection of the Ratlam site.

Shortly after IPCA suspended the shipment of all APIs made at the plant. The following year the US FDA imposed an import alert on ingredients made ar Ratlam, with the exception of hydroxychloroquine sulfate, propanolol hydrochloride, trimethoprim and ondansetron.

The Indore and Piparia finished dosage form plants were also banned from supplying the US in March 2015​.

Supplies

The supply situation that prompted the US FDA to let Ipca to keep supplying some drugs and APIs has now changed.

According to Ipca the new import ban was issued “was due to the change in drug shortage situation in the US market.​”

It said: "We also wish to further clarify that US FDA has not carried out any new inspection / reinspection of Company's above manufacturing units​."

The firm added that only one product– the API chloroquine phosphate which is made at Ratlam – had escaped the ban.

IPCA did not respond to a request for comment.

Related topics: Ingredients

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