Indoco Works To Unblock Barriers To Growth
India’s Indoco Remedies must address facility deficiencies highlighted by authorities in both the US and EU before it can revive its flagging formulations exports operation and restore top-line growth.
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India’s Indoco Remedies has received a new warning letter from the US Food and Drug Administration over its Goa manufacturing site. The company says it will take a year to fix the problems and the warning letter will delay approval of four ANDAs from the plant.
Germany’s off-patent industry association, Pro Generika, is finding ample support for its position that by awarding tender contracts to exclusive suppliers, health insurance funds are contributing to drug shortages in the country.
A patent-litigation settlement that Teva has reached with Ironwood and Allergan over Linzess will allow the Israeli firm to enter the US market with the linaclotide-based constipation treatment ahead of major rivals Mylan, Sandoz, Sun Pharma and Aurobindo.