Alembic receives FDA 483, but no repeat observations nor data issues

22-Mar-2018 - Last updated on 22-Mar-2018 at 10:42 GMT

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Alembic Pharmaceuticals has received a US FDA Form 483 with three observations at a finished formulation plant in Gujarat, India.

The US Food and Drug Administration (FDA) inspected the facility in Panelav – about 20km northeast from Vadodara – between March 12 and 20, issuing a Form 483, according to a filing with the Bombay Stock Exchange.

“This was a scheduled inspection and at the end of the inspection, the US FDA issued a Form 483 with 3 observations,” the firm said.

The oral solids facility is one of four FDA-approved manufacturing facilities owned by Alembic, but the only one that makes finished formulations for US export, rather than active pharmaceutical ingredients (APIs).

The plant was previously inspected in March 2016, resulting in a 483 with four observations but the firm said this time: “None of the observations are related to data integrity or repetitive in nature.”

Alembic is preparing to respond to the latest observations, and will submit them to the FDA in due course.

Last year, the firm inaugurated a new manufacturing facility in Panelav to make generic oncology products for international markets.