United States Food and Drug Administration (USFDA) has asked Sun Pharmaceutical Industries to take certain corrective actions at the Mohali facility before releasing further final product batches into the US, the company said in the notification to the BSE on Sunday.
"The company is taking the required corrective steps, but there will be a temporary pause in the release of batches from Mohali until USFDA-mandated measures are implemented," Sun Pharma said.
US shipments from Mohali will resume once these measures are in place, it added.
Corrective actions include retaining an independent current good manufacturing practice (CGMP) expert to conduct batch certifications of drugs manufactured at the Mohali facility.
US shipments from Mohali will resume once these measures are in place, it added.
Corrective actions include retaining an independent current good manufacturing practice (CGMP) expert to conduct batch certifications of drugs manufactured at the Mohali facility.
Sun Pharma got a consent decree correspondence/non-compliance letter from the US Food and Drug Administration for Mohali Facility.
The consent decree sets a strict timetable and requirements for the firm to ensure it obtains compliance with current good manufacturing practice (CGMP) requirements under the Federal Food, Drug, and Cosmetics Act (FD&C Act).
The facility at Mohali, Punjab was inspected from August 3 to August 12, 2022, and the USFDA classified the inspection as 'Official Action Indicated' (OAI).
“We now wish to inform you that the Company has received a letter titled 'Consent Decree correspondence/non-compliance letter’ from the US FDA. US FDA has directed the Company to take certain corrective actions at the Mohali facility before releasing further final product batches into the US,” Sun Pharma said.
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The plant was under OAI status already, which is expected to impact approvals pending for products, but does not impact the current business from the facility. Last November, Sun Pharma had said that the OAI status is not likely to have any material adverse impact on the current business from the facility. It continued to manufacture and distribute existing products for the US market.
