The United States Food & Drug Administration (USFDA) concluded a pre-approved inspection at Lupin’s biotech manufacturing facility in Pune. Following the inspection, the regulator has issued a form 483 with 17 observations.
However, the company does not expect an impact to existing revenues from this facility post the observations. The pre-approved inspection was conducted earlier this month.
Lupin has been under the regulatory lens recently with the company’s Tarapur plant receiving a warning letter last month for an inspection conducted between March and April this year. The unit had received an Official Action Initiated (OAI) status in January 2020, followed by four observations on reinspection in April this year.
The company’s Goa plant had also received a warning letter in 2017 which was lifted in December last year. Its unit in Somerset, New Jersey received an Establishment Inspection Report (EIR) in July this year with a Voluntary Action Initiated (VAI) status.
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Among other pending regulatory issues for the company, its Pithampur Unit 2 was issued a warning letter in November 2017, followed by six observations during the reinspection in January 2019. Lupin’s Mandideep Unit 1 formulation + API unit is also under a warning letter from the USFDA since September 2019.
The management said that it remains committed to resolving the issues with the regulator expeditiously.
Lupin had reported weak results during the June quarter, dragged by a 30 percent sequential decline in its US business, whose sales came in at a multi-year low. The company’s margins also fell to single digits during the quarter.
However, the street is estimating a sharp recovery for Lupin’s US sales in the September quarter. Operating margin is also likely to improve this quarter due to the potential recovery in the US business along with cost-cutting measures.
Shares of Lupin are down nearly 30 percent this year and rank among the worst performers on the Nifty Pharma index.
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HomeBusiness NewsCompanies NewsUS Regulator Asks ICICI Bank’s New York Branch To Enhance Secrecy Act Processes
US regulator asks ICICI Bank’s New York branch to enhance secrecy act processes
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ICICI Bank’s New York federal branch has entered into a consent order with its federal banking supervisor. The consent order requires the branch to enhance certain processes in its Bank Secrecy Act/Anti-Money Laundering program
ICICI Bank Ltd’s New York federal branch has entered into a consent order with its federal banking supervisor, the Office of the Comptroller of the Currency (OCC) on October 3, the company said in an exchange filing.
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The consent order requires the New York branch to enhance certain processes in its Bank Secrecy Act/Anti-Money Laundering program and establish and maintain an effective Sanctions Compliance program.
The consent order does not involve any monetary penalty.
The observations made by the OCC are restricted only to the NY Branch of the bank, the company stated in an exchange filing. The New York branch constitutes 0.6 percent of the bank’s total assets as on June 30.
The consent order will not have a material adverse effect on the bank’s business and does not restrict any of the branch’s existing activities, apart from requiring the corrective actions as specified under the consent order.
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First Published: Oct 21, 2022, 09:09 AM IST
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