Orchid says US FDA has closed PADE inspection

By Staff reporter

- Last updated on GMT

Gettyimages/gpointstudio
Gettyimages/gpointstudio

Related tags: Bombay stock exchange, Pharmaceutical drug

Orchid Pharma Ltd has received an Establishment Inspection Report (EIR) from the US FDA for its Chennai facility.

The Indian drug firm shared details in a Bombay Stock Exchange (BSE) filing yesterday​, telling investors it is “pleased to inform that Orchid received the Establishment Inspection Report (EIR) from USFDA based on the successful inspection​.”

The US Food and Drug Administration (FDA) team visited Orchid’s headquarters in Nungambakkam, Chennai in June to conduct a post-marketing adverse drug experience reporting inspection (PADE​).

Bankruptcy

Orchid is currently going through bankruptcy proceedings initiated against it by investors last August.

A resolution professional (RP) appointed in October​ to manage the insolvency process is assessing solutions to Orchid's financial woes, including seeking expressions of interest from companies interested in a takeover.

In December, Aurobindo Pharma Limited denied rumours it is interested in buying Orchid telling​ the Bombay stock Exchange (BSE) an Economic Times story ​ suggesting it is one of seven firms looking at Orchid is “factually incorrect.”

Dr Reddy's, which was also rumoured to be a potential suitor, told​ the BSE the reports are “purely speculative.”

Orchid Assets

Orchid makes injectable drugs and active pharmaceutical ingredients (API) for the domestic and export markets.

The Nungambakkam-headquartered firm has ingredient plants in Alathur, Chennai and a finished dosage form site in neighbouring Irungattukottai.

According to its website – have all passed inspections by the US Food and Drug Administration (FDA) and the UK MHRA.

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