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Indoco Aims To Leave Regulatory Woes Behind

Indian Firm Sees Third-Quarter Profit Jump By Over 70%

Executive Summary

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.

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Biocon Pharma’s solid-dosage plant has received FDA inspection approval but its parent company was not so lucky, with one of its sites getting hit with five observations. Indoco, Strides, and Lupin were also in the regulatory spotlight while MedPharm has moved into a new, expanded facility and Coripharma has signed a packaging deal with Stada.

Indoco Grows By Over A Fifth

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.

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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