Indoco Remedies’ AnaCipher gets ANVISA approval for clinical and bioanalytical facilities
The approval authorises the CRO to conduct bioavailability and bioequivalence studies for submission to Brazil, with associated bioanalytical support
Indoco Remedies has announced that its Clinical Research Organisation (CRO), AnaCipher, has received approval from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) for its clinical and bioanalytical facilities. The inspection was conducted from March 30 to April 7, 2026.
With this approval, AnaCipher is authorised to conduct bioavailability and bioequivalence studies for submission to Brazil, along with associated bioanalytical support in accordance with ANVISA’s regulatory requirements.
Commenting on the development, Aditi Panandikar, Managing Director, Indoco Remedies, 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 further strengthens AnaCipher’s international regulatory footprint and reinforces its position as a trusted partner for global clinical research programmes.
Headquartered in Hyderabad, India, AnaCipher provides bioequivalence and bioavailability studies, bioanalysis, clinical operations, regulatory affairs, data management and biostatistics services to pharmaceutical companies worldwide.
The CRO has been accredited by 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.