Sun Pharma, one of the leading global generic drug companies, will stop releasing batches from its Punjab-based Mohali facility to the US market. However, this halt is temporary and is in line with corrective actions directed by the US healthcare regulator FDA.
In your regulator on Sunday, Sun Pharma informed that it has received a letter from the US FDA titled “Consent Decree Correspondence/Non-Compliance Letter”.
through letter US FDA Directed the company to take certain corrective actions at the Mohali facility before releasing the final product batch to the US.
“These actions include retaining an independent cGMP expert to conduct batch certification of drugs manufactured at the Mohali facility,” Sun Pharma’s filing said.
Therefore, Sun Pharma said, the company is taking necessary corrective steps, but there will be a temporary halt in releasing the batch from Mohali till the US FDA-mandated measures are implemented.
Accordingly, US shipments from Mohali will resume once these measures are in place.
Sun Pharma’s Mohali plant came under the US regulator’s radar in August last year. The FDA inspected the plant from August 3 to August 12, 2022. The inspection was classified as an “Official Action Indication” (OAI).
At that time in August, as part of the findings of the inspection, the FDA issued a Form-483 with 6 observations. Sun Pharma said, it is committed to working closely with the US FDA and continuing to enhance its compliance on an ongoing basis.
Sun Pharma share price on Friday last week 989.15 on BSE, marginally up from the previous session’s print. its m-cap is over 2.37 lakh crore.
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