Indoco Remedies jumped by 4.08 per cent to Rs 368.95 after the announcement that its clinical research organization (CRO) AnaCipher has cleared United States Food and Drug Administration (USFDA) inspection with zero 483 observations.
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On Monday, the drug maker said that the company’s CRO AnaCipher was inspected by the United States Food and Drug Administration (US FDA) from 12 Sep to 16 Sep 2022. The clinical phase of inspection covered three BA/BE studies submitted by clients to the US FDA and concluded with zero 483 observations.
Also, the CRO has expertise in Bioanalytical work for new chemical entities (Phase I-III studies) for pharmaceutical companies. The CRO has successfully completed more than 500 studies in multiple therapeutic areas such as diabetes, cardiovascular, antacids, oncology and antiretrovirals.
Aditi Kare Panandikar, managing director, Indoco Remedies, “This is the seventh successive US FDA inspection with zero 483s for AnaCipher CRO. We are committed to strict adherence to all applicable guidelines and regulations and maintaining the highest quality standards in delivering quality services to our clients.”
Across 55 countries, the company has fully integrated and research-oriented pharma. Indoco Remedies’ shares fell by 2.7 per cent and the net profit to Rs 38.57 crore also the net sale of the company to Rs 395.21 crore in the first quarter of FY23 as compared with the first quarter of the last year 2022 on a consolidated basis.