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usfda: Sun Pharma tanks on USFDA observations on Halol plant

MUMBAI: Sun Pharma announced on Tuesday the US drugs regulator, US Food and Drug Administration has issued a ‘Form 483’, after inspecting its Halol facility in Gujarat. The action led to a near 3% fall in the company’s scrip to close at Rs 861.60 on the BSE.
“At the conclusion of the inspection, the USFDA issued a Form-483, with 10 observations,” the company said in a BSE filing.
The issuance of Form 483 implies that the USFDA found certain procedural lapses at the plant, and would seek corrective action from the company.
Exports to the US from Halol, as of March 2020, contributed approximately 3-4% of the company’s consolidated revenues.
The company said the US FDA conducted a good manufacturing practices (GMP) inspection of the Halol plant from April 26 to May 9.
“The company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days. It is committed to addressing these observations promptly and remains committed to working closely with the US FDA and continues to enhance its GMP compliance on an ongoing basis,” it added.
Troubles at the Halol facility have been there for a while now. The plant was last inspected by USFDA in December 2019, after which an official action indicated (OAI) was issued in March 2020. An OAI means that the USFDA expects more corrective actions to be undertaken by the company for that particular facility.
The plant has been under regulatory glare since December 2015, when the warning letter to the company was issued. This was resolved after nearly three years in June 2018, after multiple USFDA inspections. However, after an inspection in the following year, USFDA issued eight observations, leading to the March development.
Under the existing status, the company can continue with its exports of essential drugs– previously approved — to the US, but no new medicines can be shipped. Till the issue is resolved, no fresh drug filings can be made from the plant.

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