The firm expects the company to get clearance for the Halol plant in the next 4-6 months adding that the US FDA observations are not very serious. It is of the view that observations 2 and 3 are procedural in nature while observation 1 relates to aseptic processing of drug products.
Shares of Sun Pharmaceutical Industries were trading lower by 0.4 percent intraday on Tuesday, hitting a high of Rs 561 per scrip.
Global research house Credit Suisse has come out with a report on pharma major Sun Pharmaceutical Industries wherein the house feels that the Halol facility observations require remediation, but likely no re-inspection.
The firm expects the company to get clearance for the Halol plant in the next 4-6 months adding that the US FDA observations are not very serious. It is of the view that observations 2 and 3 are procedural in nature while observation 1 relates to aseptic processing of drug products.
US FDA issued three Form 483 observations for its Halol site in Gujarat. The company didn't disclose the nature of these observations. It conducted Good Manufacturing Practices (GMP) inspection of Sun Pharma's Halol facility from February 12 - 23.
"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," said Sun Pharma in a statement to stock exchanges.
At 09:24 hrs Sun Pharmaceutical Industries was quoting at Rs 552.95, up Rs 5.10, or 0.93 percent. It has touched an intraday high of Rs 562.00 and an intraday low of Rs 552.10. The share touched its 52-week high Rs 728.45 and 52-week low Rs 433.15 on 14 March, 2017 and 14 August, 2017, respectively.
The latest book value of the company is Rs 86.99 per share. At current value, the price-to-book value of the company was 6.36. The dividend yield of the company was 0.63 percent.
