Sun Pharma rises again with FDA cholesterol drug approval

pharmafile | June 13, 2017 | News story | Manufacturing and Production Sun Pharma 

Sun Pharma has had a rough time of late, the FDA has become more aggressive in its overseeing of manufacturing facilities around the world and the company has been on the receiving end of several warnings. With bans in place stopping facilities exporting drugs to the US, such as its Halol plant, it has experienced a massive drop in sales.

Now, it has finally had some good news from the FDA – one of its subsidiary’s has gained approval to produce a generic version of MSD’s anti-cholesterol drug, Zetia. The tablets had annual sales of $2.7 billion in the US last year and Sun Pharma will be hoping to take a chunk of that market.

Glenmark Pharmaceuticals had already launched the first generic version of the tablets and, in that 180-day period of exclusivity, suggested that it had achieved approximately $200 million in revenue from the drug.

Cadila Healthcare was also given approval by the FDA to release its own generic version so the marketplace will become increasingly crowded.

Regardless of competition, it will provide Sun Pharma with a much needed sales boost, as it grapples with its struggles in the US. Revenue in the US was down 34% in the fourth quarter, as a result of the FDA’s inspection and citation of its facilities. The US remains a huge market for Sun Pharma, representing 50% of sales for the company.

Founder and Managing Director of Sun Pharma, Dilip Shanghvi, has been particularly hit by the company’s ailing fortunes. His personal net worth has plummeted by $14.1 billion in just two years. This has seen him drop from his previous position as India’s wealthiest man to sixth in the standings.

The positive news regarding Zetia generics should come as a welcome balm to the series of bumps the company has received recently. Share price in the company rose by 3.65% on the news.

Ben Hargreaves

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