Indoco Remedies soars after its CRO clears US FDA inspection with zero 483s

Indoco Remedies jumped 4.08% to Rs 368.95 after the company announced that its clinical research organisation (CRO) AnaCipher has cleared US FDA inspection with zero 483 observations.

In an exchange filing made during market hours today, the drug maker said that the company's CRO AnaCipher was inspected by the United States Food and Drug Administration (US FDA) from 12 September to 16 September 2022.

The clinical phase of inspection covered three BA/BE studies submitted by clients to the US FDA and was successfully concluded with zero 483 observations.

Hyderabad-based AnaCipher CRO is a clinical research facility and is spread over 40,000 sq. ft area with 98 beds and staffed by experienced professionals providing clinical trial solutions and conducts bioequivalence and bioavailability (BA/BE) studies at its facility.

The CRO also has expertise in Bioanalytical work for new chemical entities (Phase I-III studies) for pharmaceutical companies globally. The CRO has successfully completed more than 500 studies in multiple therapeutic areas such as, cardiovascular, diabetes, oncology, anti-retrovirals and antacids.

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.

Indoco Remedies is a fully integrated, research-oriented pharma company with presence in 55 countries.

The company reported 2.7% fall in consolidated net profit to Rs 38.57 crore despite of 3.6% rise in net sales to Rs 395.21 crore in Q1 FY23 over Q1 FY22.

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