USFDA warning letter to Lupin’s US facility

Our Bureau. Mumbai | Updated on June 14, 2021

Lupin now has 5 sites under warning letters from the USFDA

Drugmaker Lupin has received a warning letter from the US Food and Drug Administration for its Somerset, (New Jersey) facility.

The US regulator had inspected the Lupin Somerset site between September 10, 2020 and November 5, 2020, the drugmaker said. The development was unlikely to have an impact, disrupt supplies or existing revenues from this facility, it added.

Also read: Lupin shares drop nearly 3% on USFDA warning letter for Somerset facility

The said the plant is Lupin’s only manufacturing facility in the US, and the impact on revenues due to the warning letters was minimal, said a report from Motilal Oswal Financial Services., adding however, that the development would prolong the process for future approvals from this site.

With this, Lupin has five sites under warning letters or OIAs (Official Action Indicated), from the USFDA. “The near-to-medium term earnings trajectory remains unperturbed as critical inhaler products are manufactured at the site that is USFDA-compliant. However, the extended period to resolve regulatory issues at the five sites (partly due to the pandemic) is impacting the overall utilisation of assets for the US market,” the analyst report said.

Somerset issues

Lupin’s Somerset facility was inspected in December 2018 and the facility was subsequently issued an OAI in March 2019, the report said. With the Covid-19-led lockdown easing and efforts implemented to address the issues highlighted by the USFDA, Lupin faced an inspection at this site in September2020. “The USFDA issued Form 483 with 13 observations at this site post the inspection. Due to inadequate remediation measures to address the observations, the USFDA has recently issued a WL (warning letter) for this site,” the report said. “The revenue contribution from this site is less than 5 per cent of LPC’s (Lupin’s) global revenues. Also, while the issuance of the WL has not halted ongoing business from this site, new approvals may get delayed,”the report said.

Other plants

Giving an overview, the report said, Lupin’s Mandideep Unit 1 had been inspected in December 2018, after which the facility was issued a WL in September 2019. “No ANDA (abbreviated new drug application) is pending approval from this site.” The company’s Goa plant was inspected in March 2017 and the Pithampur Unit 2 in May 2017. Subsequently, the company received WLs for both facilities; these were inspected again in January-February 2019 and issued a “Form 483” with two-to-six observations.

The OAI classification at Goa / Pithampur Unit 2 implies that remediation measures are not satisfactory, the report said, adding, “The company has since implemented further measures to address the concerns raised by the USFDA. The ongoing pandemic has partly delayed inspector visits to the site (due to travel restrictions). Overall, this has led to a reduction in the commercial benefits, thereby impacting returns on investment.”

Published on June 14, 2021

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