Indoco Remedies' AnaCipher Gets Brazil ANVISA Approval for Clinical, Bioanalytical Facilities

With the approval, AnaCipher is authorised to conduct bioavailability and bioequivalence (BA/BE) studies for submission in Brazil, along with associated bioagtrmnalytical support, in accordance with ANVISA’s regulatory requirements.

Commenting on the development, Aditi Panandikar, Managing Director of Indoco Remedies Ltd., said, “The approval reflects our CRO’s robust quality management systems, qualified scientific and clinical teams, validated analytical capabilities, and adherence to international regulatory and Good Clinical Practice standards. It reinforces our commitment to global quality standards and enhances our ability to support pharmaceutical companies in conducting studies for Brazil and expanding across Latin America.”

The approval strengthens AnaCipher’s international regulatory footprint and its ability to support global clinical research programmes.

Headquartered in Hyderabad, India, AnaCipher provides bioavailability and bioequivalence studies, bioanalysis, clinical operations, regulatory affairs, data management and biostatistics services to pharmaceutical companies worldwide.

According to the company, AnaCipher has received accreditations from the Central Drugs Standard Control Organisation (CDSCO), the US Food and Drug Administration (USFDA), the World Health Organization (WHO), the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the Ministry of Health of Oman. It has also received project-based approvals from Health Canada’s Therapeutic Products Directorate (TPD), China’s National Medical Products Administration (NMPA), South Africa’s Medicines Control Council (MCC) and the Ministry of Health of Iraq.