USFDA issues form 483 to Sun Pharma Halol unit with 10 observations

10 May 2022 , 12:29 PM

Shares of Sun Pharma trading lower in the noon trade after the US FDA issued a Form-483, with 10 observations.

In the regulatory filing, the USFDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited’s Halol facility (Gujarat, India) from April 26 to May 9, 2022. At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations.

The Company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days. The Company is committed to addressing these observations promptly.

The stock is currently trading at Rs862.15 down by Rs23.2 or 2.62% from its previous closing of Rs885.35 on the BSE.

The Company remains committed to working closely with the USFDA and continues to enhance its GMP compliance on an ongoing basis, it added.

The scrip opened at Rs879.20 and has touched a high and low of Rs890.55 and Rs846.35 respectively.