Indoco Remedies has added Brazil to the list of regulators that recognise its contract research business. The Mumbai-based drugmaker said on 27 October 2026 that AnaCipher, its Hyderabad-headquartered Clinical Research Organisation (CRO), has received approval from Brazil’s National Health Surveillance Agency, Agência Nacional de Vigilância Sanitária (ANVISA), for both its clinical and bioanalytical facilities.

The approval follows an ANVISA inspection carried out between 30 March and 7 April 2026. It authorises AnaCipher to conduct bioavailability and bioequivalence (BA/BE) studies intended for submission to the Brazilian regulator, together with the associated bioanalytical support, in line with ANVISA’s requirements.

Why a Brazil nod matters for a generics CRO

BA/BE studies sit at the heart of generic drug approvals. They show that a generic version delivers the active ingredient into the bloodstream at the same rate and to the same extent as the reference medicine, and regulators typically accept such data only from sites they have inspected or otherwise recognised. A site-level clearance from ANVISA therefore lets AnaCipher take on studies for sponsors that are building dossiers for Brazil, the largest pharmaceutical market in Latin America, and positions the CRO to support filings across the wider region.

For Indian generics companies that already run studies for the US, European or UK markets, the ability to place Brazil-bound work with an approved Indian CRO could simplify programme planning and keep more of the clinical and bioanalytical value chain within the country.

Management view

Aditi Panandikar, Managing Director, Indoco Remedies, said the approval reflects the CRO’s quality management systems, its qualified scientific and clinical teams, validated analytical capabilities and adherence to international regulatory and Good Clinical Practice (GCP) standards. She added that it strengthens the company’s commitment to global quality standards and enhances its ability to support pharmaceutical companies conducting studies for Brazil and expanding across Latin America.

A growing regulatory footprint

The ANVISA clearance adds to an existing set of credentials. According to the company, AnaCipher is accredited by India’s 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, China’s National Medical Products Administration (NMPA), South Africa’s Medicines Control Council and Iraq’s Ministry of Health.

AnaCipher offers BA/BE studies, bioanalysis, clinical operations, regulatory affairs, data management and biostatistics services to pharmaceutical clients worldwide. Indoco describes the CRO, a division of the company, as a facility spread over about 40,000 sq ft in Hyderabad, with capabilities spanning bioanalytical method development and validation, sample processing and analysis, statistical analysis and reporting.

Indoco has not disclosed any financial impact, study volumes or validity period linked to the approval.

The bigger picture

As Indian drugmakers look beyond the US for growth in regulated and semi-regulated generics markets, Latin America has become an increasingly important destination, and ANVISA’s standards are among the more demanding in emerging markets. Approvals such as this one show how India’s CRO ecosystem is evolving from a cost-led service base into a multi-regulator, quality-led partner for global generic development, a shift that will shape how Indian companies take products to new markets in the years ahead.

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