The consolidated profit in addition to revenue may also be adversely impacted due to certain expenses/ charges arising out of integration and remedial actions.
Ranbaxy has first-to-file status, meaning eligibility for six months of generic sales exclusivity for both AstraZeneca's heartburn drug Nexium & Roche's antiviral drug Valcyte drugs. However, the final approvals for these drugs were delayed because of the compliance issues at Ranbaxy's plants.
Ranbaxy has recalled tablets of atorvastatin calcium, the generic name for Lipitor's active ingredient, after a pharmacist found a 20-milligram tablet in a sealed bottle marked for 10-milligram tablets, the US Food and Drug Administration (FDA) said.
The drug major said that it is a voluntary decision as a precautionary measure to better to assess and review the processes and controls. It has also formed ‘quality & integrity committee'.
In January, the US Food and Drug Administration banned the Toansa plant, a key supplier of ingredients to the generic drugmaker's US factory, from sending its products to the United States due to manufacturing violations.
In a conference call, the company, now owned by Japanese Daiichi Sankyo, said it was committed to resolving issues with the FDA, which has now banned imports from all four its plants in India.
Total income from operations grew 6.7 percent to Rs 2,894 crore during the quarter as against Rs 2,711.2 crore in a year ago period.
Analysts are worried about the guidance (Rs 13,000-13,500 crore - with no first-to-file included) after the US Food and Drug Administration (USFDA) banned manufacturing and distributing active pharmaceutical ingredients from its Toansa facility. Toansa was the fourth plant that was banned by USFDA after Mohali, Dewas and Poanta.
RANBAXY-BAN-DAIICHISANKYO:Daiichi Sankyo pledges bold action on Ranbaxy production problems
UBS maintains sell rating and reduced target price to Rs 300 from 500. Stating that downside risks remain, UBS is concerned that USFDA action removes US as a potential earnings driver and may take three to five years for issues to get resolved.
Bank and IT shares gained during the week, while those from capital goods, metal, auto, power and oil & gas shares finished lower.
Toansa is the fourth unit of the company which is banned and added to consent decree. With this, all of the company's India-based plants supplying to US are banned. Its Ohm Laboratories, the only plant which has USFDA approval, manufactures drugs using API from Toansa.
Ranbaxy tanks on USFDA blow. The US FDA bans Ranbaxy's Toansa API plant and added it to consent decree.
Arvind Bothra, VP of Religare Enterprises says even with an average multiple of 7 to 8 times sales on the domestic business, the value will be higher than the current market cap.
Ranbaxy‘s Toansa plant supplies 70 percent of US-based Ohm Laboratories‘ Active Pharmaceutical Ingredients (API) requirement. This in turn means the company will soon have to go in for outsourcing, incurring a huge costs.
Toansa is the fourth unit of the company that is banned and added to consent decree. With this, all of the company's India-based plants supplying to US are banned.
Ranbaxy has received a form 483 with certain observations from the USFDA on its Toansa bulk drug plant in Punjab.
Ranbaxy has said that it is assessing the observations and will respond to the USFDA at the earliest. This matter is critical for Ranbaxy since 70-75 percent of the company‘s manufactured active pharmaceutical ingredients (APIs) are from there, reports CNBC-TV18.