update

Wockhardt says Ireland's HPRA has recommended GMP cert renewal for Shendra site

By Gareth Macdonald contact

- Last updated on GMT

iStock/Ruskpp
iStock/Ruskpp

Related tags: Food and drug administration

Wockhardt says Irish regulators have recommended renewal of its Shendra, Aurangabad facility's GMP certificate.

The Indian drug firm announced the HPRA recommendation in a filing on the Bombay Stock Exchange (BSE) today, explaining that it followed an inspection.

According to Wockhardt “The Health Products Regulatory Authority of Ireland has inspected our Shendra, Aurangabad facility and have recommended the renewal of certificate based on the general compliance with the principles and guidelines of Good Manufacturing Practice​.”

The facility produces injectable drugs for several international markets.

The HPRA did not respond to a request for comment ahead of publication.

Untitled letter

The announcement comes just over a month after the US Food and Drug Administration (FDA) sent Wockhardt an untitled letter after inspecting the Shendra facility.

An agency spokeswoman told us "Wockhardt Shendra, FEI 3009278506, received an Untitled Letter on January 27, 2017, for manipulating and deleting data and poor aseptic practices in the manufacture of sterile drugs​."

The US FDA uses Untitled Letters for violations that are not as significant as those that trigger warning letters.

Unlike a Warning Letter, an Untitled Letter does not include a statement warning that failure to promptly correct a violation may result in an enforcement action

Other news

The announcment comes the same day as the US Food and Drug Administration (FDA) published a warning letter​ it sent to Wockhardt after an inspection at a plant run by its US subsidiary, Morton Grove​.

The headline and introduction to this article has been ammended to make clear that Wockhardt announced the HPRA recommendation.

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