Double US FDA audit for Granules India ends with one observation

By Staff Reporter

- Last updated on GMT

Granules India has received a US FDA Form 483 with one observation at a Telangana API and finished formulation facility.

The Indian drug and ingredient maker announced the result of US Food and Drug Administration (FDA) audits at two of its facilities in India in a Bombay Stock Exchange filing this morning.

“[The] Company’s Gagillapur and Jeedimetla facilities located at Hyderabad, Telangana, India has completed the US FDA inspection from 19th​ March 2018 to 23rd​ March 2018 without any 483 observations for Gagillapur facility and with 1 (one) 483 observation for Jeedimetla facility.”

Details of the observation at Jeedimetla have not been divulged, but according to the firm it will respond to the observation within the stipulated time period.

The facility makes both active pharmaceutical ingredients (APIs) and pharmaceutical formulation intermediates (PFIs).

However, the facility is only FDA approved to make APIs and currently manufactures the ingredients metformin for type 2 diabetes drugs, guaifenesin for cough medicines, and the central muscle relaxant methocarbamol.

The FDA previously audited the facility in December 2015, resulting in a 483 with three (non-data integrity-based) observations. But concerns over quality and safety observed during the inspection were ended with the issuing of an Establishment Inspection Report (EIR) in May 2016​.

The Gagillapur finished formulation and PFI facility has capacity for 18 billion tablets and capsules.

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