US FDA has concerns about Granules - Ajinomoto OmniChem's Vizag API plant

By Gareth Macdonald

- Last updated on GMT


Related tags Andhra pradesh Pharmaceutical drug Food and drug administration Fda

US FDA inspectors have raised questions about an API manufacturing facility in India that is operated by Granules India and Ajinomoto OmniChem.

Granules confirmed the US Food and Drug Administration (FDA) had inspected the plant in Vizag - Visakhapatnam - in Andhra Pradesh, India in Bombay Stock Exchange (BSE) filing this week.

It said the facility had “completed its first inspection by US FDA with seven (7) observations​” but did not provide any details.

The news saw​ Granules' share price fall 4%.

Granules' head of investor relations, Sumanta Bajpayee, was upbeat despite the FDA observations, telling us “This the first inspection for the site and we believe it is positive step towards getting the site approval."

He added: “Teams have already acted upon some of these observations and will send the response to the FDA within stipulated time period. We cannot disclose the observations till we submit our response to the FDA.

This echoes comments by Granules chairman C Krishna Prasad, CMD, Granules, who told the Economic times that "in our opinion this has been a very good audit.

"There were no serious issues or no data integrity issues and all the issues are observations, mainly procedural in matter, and most of the issues have been acted upon​."

JV ownership

The Vizag plant is owned by the 50:50 joint venture between Granules India Limited and Ajinomoto OmniChem.

It was set up in 2011​ as a production hub for low volume, high value active pharmaceutical ingredients (APIs) and intermediates for the US and European markets.

In 2015​ Granules predicted the facility would be approved to supply customers serving the US and European markets within two years. 

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