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Apr
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ragupathyrenganathan
FDA cites Lupin Indian facilities for what drugmaker calls ‘minor’ issues
Pharma News
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The manufacturing facility that India’s Lupin Pharmaceuticals recently picked up in the U.S. is looking even more valuable as FDA concerns mount at some of its Indian plants.

The drugmaker said in a Bombay Stock Exchange filing on Tuesday that it had received four observations for two plants at its Mandideep site following a two-week inspection by the FDA in February. The drugmaker received two observations for an API plant and two for a dosage form plant, but one observation was common to both facilities; so, as Lupin sees it, that was just three observations.

It called the citations “minor in nature” and said it believes the FDA will rank them as Voluntary Action Needed and that no remediation will be required. Lupin said one observation had to do with the use of a “non-conforming” intermediate used before 2015 and which Lupin said met standards after it was further processed. While the batches released to the market using the ingredient met specifications, Lupin said it recalled some of the products last year “out of an abundance of caution.”

Lupin last year also received a Form 483 with 9 observations for a plant in Goa, and the year before the FDA cited a facility in Indore with half a dozen.

Lupin, which claims to be one of the fastest-growing generics companies selling in the U.S., earlier this month completed a $900 million deal to buy New Jersey-based Gavis Pharmaceuticals. With the deal, Lupin got a 45,000-square-foot manufacturing and R&D site and a 124,000-square-foot packaging and distribution operation in Somerset, NJ. It also got a portfolio of 120 marketed products and 62 ANDA filings.

With its Gavis acquisition, Lupin joined other Indian drugmakers like Cipla, Glenmark Pharmaceuticals and others in nailing down $1.5 billion in deals for U.S. companies or new manufacturing sites in 2015. Dow Jones Business News, citing Dealogic, has reported that Indian companies have announced or completed 31 deals in the U.S. since 2010.

While having U.S. manufacturing helps with building share in the world’s largest market, some analysts believe the Indian companies see U.S. operations also as a way to offset disruptions at plants in India as the FDA has stepped up inspections there.

Glenn Saldanha, managing director of Glenmark, told Dow Jones that while the cost of doing business is much higher in the U.S., the company can manufacture more sophisticated, higher quality products here. “That is the trade-off,” he said.



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