It seems to be two steps forward, one step back for India's Lupin in its efforts to build its business in the U.S. A week after the drugmaker closed a deal that gets it its first U.S. manufacturing facility, another of its plants in India has been found lacking by the FDA.
The drugmaker reported to the Bombay Stock Exchange on Tuesday that the FDA had written up its plant in Goa with 9 observations following an inspection. Lupin said the plant was cited for its "inadequacy and adherence" to standard operating procedures. Lupin explained it is responding to the FDA about how it will address the issues.
In February 2015, Lupin disclosed the FDA had inspected two of its other facilities in India, finding one in good shape but citing the other. It said that its plant in Pune was approved with no observations but that its facility in Indore received a Form 483 citing half a dozen concerns.
Lupin, which claims to be the fastest-growing top 10 U.S. generics company, last week 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.
- here's the BSE filing