Orchid says US FDA has closed PADE inspection
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.
