 "Lupin Pharma")
Lupin has dipped almost 8% to Rs 1,525 on the BSE in early morning trade on the BSE, as analyst concerns about observations from the US drug regulator continue to remain an overhang for the near-term on the stock.
Lupin had received USFDA 483’s for Goa plants with 9 observations during March 2016. The company said it has responded to these observations and awaits US Food and Drug Administrator (USFDA) response.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Meanwhile, analysts ar Sharekhan maintain ‘Hold’ rating on the stock with revised price target of Rs 1,850.
“We have revised downwards our estimates for FY2017 and FY2018 by 6.3% and 4.4% respectively mainly due to increase in interest cost (due to increase in debt on account of acquisition) and higher tax rate (30% vs earlier 28%). Also, 483 observations from the USFDA continue to remain overhang for near term and poses an upside risk to our valuation,” the brokerage house said in stock update.
"Around 30 products are pending approval from Goa plant and around 70 from Pithampur (Indore) site. It has initiated site transfer from Goa to other FDA approved sites," added the report.
At 09:53 am, the stock was down 6% at Rs 1,556 on the BSE compared to 0.12% rise in the S&P BSE Sensex. A combined 1.07 million shares changed hands on the counter on the BSE and NSE so far.
Lupin had received USFDA 483’s for Goa plants with 9 observations during March 2016. The company said it has responded to these observations and awaits US Food and Drug Administrator (USFDA) response.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Meanwhile, analysts ar Sharekhan maintain ‘Hold’ rating on the stock with revised price target of Rs 1,850.
“We have revised downwards our estimates for FY2017 and FY2018 by 6.3% and 4.4% respectively mainly due to increase in interest cost (due to increase in debt on account of acquisition) and higher tax rate (30% vs earlier 28%). Also, 483 observations from the USFDA continue to remain overhang for near term and poses an upside risk to our valuation,” the brokerage house said in stock update.
"Around 30 products are pending approval from Goa plant and around 70 from Pithampur (Indore) site. It has initiated site transfer from Goa to other FDA approved sites," added the report.
At 09:53 am, the stock was down 6% at Rs 1,556 on the BSE compared to 0.12% rise in the S&P BSE Sensex. A combined 1.07 million shares changed hands on the counter on the BSE and NSE so far.
