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    • TABLET, ORALLY DISINTEGRATING;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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    The silver lining in Ipca’s Import Alert blues

    The silver lining in Ipca’s Import Alert blues

    Ipca Laboratories finished dosage facilities at Silvasa and Pithampur (India) were put on the FDA Import Alert List this week, an outcome of Ipca running into problems in yet another FDA inspection. The latest alert comes after Ipca’s API facility in Ratlam (India) was banned from exporting to the U.S. in January this year. However, when reviewing the details of Ipca’s alert, is there a business opportunity which can be capitalized upon? The FDA Import Alert, while banning all imports from the Pithampur facility, has stopped everything coming out of the Silvasa plant except Hydroxychloroquine Sulfate & Propranolol Hydrochloride. Ipca’s Ratlam facility had received a similar exemption earlier for the following APIs: Sulfamethoxazole, Trimethoprim, Ondansetron, Hydroxychloroquine Sulfate, Propranolol Hydrochloride and Furosemide. Given all the details that have been published about the observations at Ipca’s various facilities, a complete shutdown of all imports into the U.S. would have been expected.   Why did a few of Ipca’s products get an FDA import alert exemption? Business Standard reported, at the time of covering the initial Ratlam ban that “Given the acute shortage in the US, the FDA, however, has exempted four APIs from the import ban.” The article also mentions the market growth of Hydroxychloroquine from $30 million to $120 million in the last few years. While the FDA hasn’t yet put Hydroxychloroquine on their drug shortage list, concerns regarding supply disruption are already being felt. Wyeth’s branded Propranolol Hydrochloride was a $215 million product in 2006, before intense generic competition reduced the market to about 10% of its original size in less than two years. While almost every major generic company has some variant of Propranolol Hydrochloride on the market, the number of API suppliers are extremely limited. Pharma Compass’ database shows that as Ipca, Albemarle (USA) and Cosmo Spa (Italy) are the only active Drug Master Files in the FDA database, capacity expansion constraints in Europe and United States could provide an opportunity for compliant API manufacturing of Propranolol Hydrochloride.  With API manufacturers looking for new horizons, Ipca’s exemptions of old products like Sulfamethoxazole, Trimethoprim, Ondansetron, Hydroxychloroquine Sulfate, Propranolol Hydrochloride and Furosemide should provide an manufacturing and marketing opportunity worth examining. Search our database for Sulfamethoxazole, Trimethoprim, Ondansetron, Hydroxychloroquine Sulfate, Propranolol Hydrochloride and Furosemide to study the competitive landscape of manufacturers, pricing information and a lot more. 

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    https://www.pharmacompass.com/radio-compass-blog/the-silver-lining-in-ipca-s-import-alert-blues

    #Phispers by PHARMACOMPASS
    27 Mar 2015
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