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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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.
India’s Strides has received a warning letter from the US Food and Drug Administration over compliance issues at its Puducherry plant. However, the firm has told investors the regulatory action will not affect its forecast of 20% US sales growth for this financial year.