The US Food and Drug Administration (USFDA) has banned Ranbaxy's Punjab-based Toansa Active Pharmaceutical Ingredients (API) plant.
The US drug regulator added this plant to ongoing consent decree. With this, Toansa is the fourth unit of the company that will be banned and added to consent decree.
With this, all of the company's India-based plants supplying to US are banned.
US FDA has found major current good manufacturing practice (cGMP) violation in Toansa inspection. The regulator inspected this plant on January 11, 2014.
"Toansa retested drugs even after failed initial tests. Retesting was done for producing acceptable findings and so as to not report initial failures," USFDA statement said.
After the ban, the company cannot sell drugs manufactured in Toansa unit in the US and cannot export API for any purpose.
Ranbaxy also can't provide API from Toansa to other companies' making products for US.
Its Ohm Laboratories, which is based in New Jersey and the only plant that has USFDA approval, manufactures drugs using API from Toansa.
Prabhudas Lilladher feels this ban on Toansa unit is a huge negative for Ranbaxy and expects Ranbaxy to report negative EBITDA.
"Toansa unit is accounted for 70 percent API for company's US business. So the prospect is bleak for the company in near to mid-term," the brokerage house said.
Prabhudas said it will buy Ranbaxy in `200-250/sh range in long-term while Espirito Santo Securities said it will continue to avoid Ranbaxy until clarity emerges.
Ranbaxy Labs stock price
On January 24, 2014, at 09:20 hrs Ranbaxy Laboratories was quoting at Rs 344.00, down Rs 73.15, or 17.54 percent. The 52-week high of the share was Rs 490.15 and the 52-week low was Rs 253.95.
The latest book value of the company is Rs 45.34 per share. At current value, the price-to-book value of the company was 7.59.
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