The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
United States Food and Drug Administration (USFDA) has conducted a good manufacturing practices (GMP) inspection of Sun Pharmaceutical Industries' Halol facility (Gujarat, India) from December 03-13, 2019, as per company release.
At the conclusion of the inspection, the agency issued a Form 483, with eight observations.
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days, it said in release.
The company is committed to addressing these observations promptly.
The company remains committed to working closely with the USFDA and continues to enhance its GMP compliance on an ongoing basis, it added.
On December 13 share price of Sun Pharmaceutical Industries ended 1.12 percent higher at Rs 438.65 on the BSE.
The share touched its 52-week high Rs 484.10 and 52-week low Rs 350.40 on 01 April, 2019 and 13 May, 2019, respectively.Currently, it is trading 9.39 percent below its 52-week high and 25.19 percent above its 52-week low.Get access to India's fastest growing financial subscriptions service Moneycontrol Pro for as little as Rs 599 for first year. Use the code "GETPRO". Moneycontrol Pro offers you all the information you need for wealth creation including actionable investment ideas, independent research and insights & analysis For more information, check out the Moneycontrol website or mobile app.