Indoco Grows By Over A Fifth
Indian Firm Waits For ANDA Approvals After FDA Inspection
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.
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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.
Aurobindo has received further Form 483s from the FDA, while Biocon has received an EIR for its Bengaluru facility. The FDA has also successfully concluded inspections for Indoco and Lupin, while ANI, Aptar and MicroSphere have made strategic moves.
Dr Reddy’s, Ipca Labs and Yino have received Form 483s over quality control issues. Meanwhile, Bora Pharma, Unichem and Laurus Labs have successful FDA inspections and Indoco Remedies gets its GMP status fully reinstated.