AnaCipher Receives ANVISA Brazil Approval for Clinical and Bioanalytical Facilities to Support BA/BE Studies for Brazilian Submissions

• AnaCipher, the Hyderabad, India-based CRO of Indoco Remedies Ltd., has received approval from Brazil’s National Health Surveillance Agency (ANVISA) for both its clinical and bioanalytical facilities, following an inspection conducted from March 30 to April 7, 2026.

• The approval authorizes AnaCipher to conduct bioavailability and bioequivalence studies for submission in Brazil, with associated bioanalytical support in line with ANVISA requirements, extending the CRO’s international regulatory footprint.

AnaCipher, the clinical research organization of Indoco Remedies Ltd., has received approval from the National Health Surveillance Agency of Brazil (ANVISA) for its clinical and bioanalytical facilities. The approval was announced on October 27, 2026. It follows an ANVISA inspection that ran from March 30 to April 7, 2026. AnaCipher is headquartered in Hyderabad, India.

The approval authorizes the CRO to conduct bioavailability and bioequivalence (BA/BE) studies for submission to Brazil. It also covers the associated bioanalytical support, which must be delivered in accordance with ANVISA regulatory requirements. Approval of both the clinical and bioanalytical sites means a sponsor can run the clinical and analytical phases of a BA/BE study for Brazil with the same CRO.

AnaCipher provides BA/BE studies, bioanalysis, clinical operations, regulatory affairs, data management, and biostatistics services to pharmaceutical companies worldwide. The CRO holds accreditations from CDSCO, USFDA, WHO, EMA, UK MHRA, and MoH-Oman. It has also received project-based approvals from TPD-Canada, NMPA-China, MCC-South Africa, and MoH-Iraq. ANVISA is the latest addition to that list. The company said the approval strengthens its international regulatory footprint.

Indoco Remedies is a fully integrated, research-oriented pharmaceutical company with turnover of US$175 million and more than 6,000 employees. It operates 10 manufacturing facilities, six for finished dosage forms and four for APIs, alongside an R&D center and the CRO facility. The company said the approval enhances its ability to support pharmaceutical companies conducting studies for Brazil and expanding across Latin America.

“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.”

Aditi Panandikar, Managing Director, Indoco Remedies Ltd.