This story first appeared in DNA Money edition on Tuesday, January 14, 2014
Troubles do not seem to end for Ranbaxy Laboratories, which saw its shares tank 9.47% on Monday after one of its key facilities at Toansa, Punjab, was slapped with Form 483 by the US Food and Drug Administration (FDA).
Form 483 is issued at the conclusion of an inspection when investigators observe any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.
The shares of Ranbaxy, the biggest Indian drugmaker by sales, opened at Rs 466 on Monday and reached a low of Rs 420 before closing the day at at Rs 438.80, down 5.58% from the previous close.
This is the second biggest fall since September 2013 when the stock had lost 30.27% of its value following an import alert on its Mohali plant by the US FDA for violation of current good manufacturing practices.
In a note to the exchanges, Ranbaxy said, “It is assessing the observations, and will respond to the US FDA in accordance with the agency’s procedure to resolve the concerns at the earliest.”
While Ranbaxy management did not share any production related details, industry experts said the plant manufactures around 70-75% of its API requirements.
Under the Form 483 process, the company would now have to respond with its corrective action plan and implement it expeditiously or face an import alert.
Sarabjit Kour Nangra, vice-president, research-pharma, Angel Broking, said, “During the second quarter of calendar year 2013, its other key facility at Mohali came under US FDA import alert. With this plant also under scanner, it would have impact on the operations of the company in the US, unless it can compensate for the same at the earliest and mange a smooth supply of key raw materials,” said Nangra.
She said more clarity is awaited from the Ranbaxy management in order to ascertain the exact impact on the financials, especially operating profit margins.
“Until then, the company could trade at a huge discount to its peers,” said Nangra.
Getting US FDA clearance will be crucial for Ranbaxy considering all of its India-based factories are currently banned by the regulator from exporting medicines to the US, its largest market.
Last week Ranbaxy inked a licensing pact with EPIRUS Switzerland GmbH for BOW015, a biosimilar version of Infliximab, prescribed to treat rheumatoid arthritis, and said the product will be introduced in India and other emerging markets.
Ranjit Kapadia, senior vice-president - pharma, Centrum Broking, said the molecule has only completed Phase 3 studies. “It would take 12-18 months to get regulatory approval and commercialise the product in India,” he said.
Troubles do not seem to end for Ranbaxy Laboratories, which saw its shares tank 9.47% on Monday after one of its key facilities at Toansa, Punjab, was slapped with Form 483 by the US Food and Drug Administration (FDA).
Form 483 is issued at the conclusion of an inspection when investigators observe any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.
The shares of Ranbaxy, the biggest Indian drugmaker by sales, opened at Rs 466 on Monday and reached a low of Rs 420 before closing the day at at Rs 438.80, down 5.58% from the previous close.
This is the second biggest fall since September 2013 when the stock had lost 30.27% of its value following an import alert on its Mohali plant by the US FDA for violation of current good manufacturing practices.
In a note to the exchanges, Ranbaxy said, “It is assessing the observations, and will respond to the US FDA in accordance with the agency’s procedure to resolve the concerns at the earliest.”
While Ranbaxy management did not share any production related details, industry experts said the plant manufactures around 70-75% of its API requirements.
Under the Form 483 process, the company would now have to respond with its corrective action plan and implement it expeditiously or face an import alert.
Sarabjit Kour Nangra, vice-president, research-pharma, Angel Broking, said, “During the second quarter of calendar year 2013, its other key facility at Mohali came under US FDA import alert. With this plant also under scanner, it would have impact on the operations of the company in the US, unless it can compensate for the same at the earliest and mange a smooth supply of key raw materials,” said Nangra.
She said more clarity is awaited from the Ranbaxy management in order to ascertain the exact impact on the financials, especially operating profit margins.
“Until then, the company could trade at a huge discount to its peers,” said Nangra.
Getting US FDA clearance will be crucial for Ranbaxy considering all of its India-based factories are currently banned by the regulator from exporting medicines to the US, its largest market.
Last week Ranbaxy inked a licensing pact with EPIRUS Switzerland GmbH for BOW015, a biosimilar version of Infliximab, prescribed to treat rheumatoid arthritis, and said the product will be introduced in India and other emerging markets.
Ranjit Kapadia, senior vice-president - pharma, Centrum Broking, said the molecule has only completed Phase 3 studies. “It would take 12-18 months to get regulatory approval and commercialise the product in India,” he said.
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