The Hindu Business Line : USFDA nod opens up revenue opportunity

The USFDA has granted approval for Sun Pharmaceutical’s Abbreviated New Drug Application (ANDA) to market generic Sinemet®, carbidopa and levodopa tablets. Used in the treatment of Parkinson’s disease and syndrome, these drugs enjoy annual sales of approximately $70 million (about Rs 330 crore) in the US.

Besides opening a revenue opportunity for Sun Pharma, this announcement may provide investors with some relief as far as the company’s business prospects are concerned as only a couple of days back the company’s subsidiary in the US, Caraco Pharmaceutical Laboratories had received a warning letter from the FDA.

The warning letter, which was issued as a follow up to the last FDA inspection of the Caraco’s manufacturing facility in Detroit, may not hold any near-term revenue impact for Sun.

However, it needs to be seen how Caraco clarifies the issues raised by the FDA, for on failure to resolve the concerns raised by the FDA, the latter will reserve the right to withhold approval of pending new drug applications, which list the Detroit facility as the manufacturer.

That Caraco currently has 19 pending new drug applications of a total of 96 may also put in perspective what could be at stake for Sun Pharma if it fails to resolve the issue.

Caraco accounted for over $125 million of manufactured sales in FY08.

That said it however may not have any impact on Sun Pharma’s revenue projections from its two “at risk” launches in the US – Protonix, the heart-burn drug and Ethyol, the cancer-related drug – as they are manufactured from facilities in India.

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‘Caraco warning letter not to impact revenues of Sun Pharma’
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