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Lupin gets US health agency warning over shortcomings at Tarapur plant

Lupin gets US health agency warning over shortcomings at Tarapur plant

Lupin gets US health agency warning over shortcomings at Tarapur plant
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By Nishtha Pandey  Nov 3, 2022 4:36:25 PM IST (Published)

Lupin's "failure to create acceptable documented processes for cleaning equipment and its release for use in the manufacture of intermediates and API" was cited by the health authorities in the warning notice.

Drug manufacturer Lupin has received a warning notice from the US Food and Drug Administration (USFDA) for manufacturing errors, including failing to establish proper written procedures for cleaning equipment at its Maharashtra-based plant.

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In a warning letter, the USFDA has pointed out various lapses at the Tarapur (Thane) plant which produces active pharmaceutical ingredients (API). Earlier in September, the company had received another letter for the same plant. 
"This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API)," Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated," said USFDA.
The manufacturing facility was inspected by the USFDA from March 22 to April 4, 2022.
When the US health agency determines that a manufacturer has flagrantly broken its rules, a warning letter is sent.
Lupin's "failure to create acceptable documented processes for cleaning equipment and its release for use in the manufacture of intermediates and API" was cited by the health authorities in the warning notice.
The failure of the drugmaker to create documented processes to track the development and regulate the execution of processing stages that can cause variation in the quality attributes of intermediates and API was also highlighted.
The USFDA also said the plant administration failed to investigate all critical deviations.
"We acknowledge your commitment to suspend production of drugs for the US market. In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility in the future," it said.
If the company plans to resume manufacturing drugs for the US market, notify this office before resuming operations, the letter said.
"The warning letter notifies you of our findings and provides you with an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence," said USFDA.
With inputs from PTI.
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