Indoco FDA Warning Letter Will Take 12 Months To Resolve
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.
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Difficulties at two of its manufacturing facilities in Goa have led to a disappointing Q1 for Indoco, as the firm saw milestone payments delayed after receiving official action indicated status from the FDA.
India’s Indoco Remedies is looking for healthy revenue growth in the coming fiscal year after beating market estimates with a 70.4% year-on-year jump in after-tax profit in its financial third quarter, propelled by strong revenues from domestic and international markets.
Indoco has reported 21% sales growth in its financial second quarter and is awaiting a string of ANDA approvals after successfully completing FDA inspections of a Goa steriles plant and its Hyderabad-based clinical research organization. However, an FDA warning letter hangs over another facility.