AnaCipher, the contract research organisation (CRO) of Indoco Remedies Limited, has received approval from Brazil’s National Health Surveillance Agency (ANVISA) for its clinical and bioanalytical facilities. The approval authorises the facilities to conduct bioavailability and bioequivalence studies for submissions in Brazil, along with the associated bioanalytical support required under ANVISA regulations.
The regulatory inspection was conducted between March 30 and April 7, 2026. The approval covers both the clinical and bioanalytical operations of AnaCipher and allows the organisation to support pharmaceutical companies seeking regulatory submissions in the Brazilian market.
The authorisation adds Brazil to AnaCipher’s international regulatory network and supports its work with companies developing generic medicines for overseas markets. Bioavailability and bioequivalence studies are used to establish how a drug is absorbed and whether a generic formulation performs comparably to its reference product. These studies form an important part of regulatory submissions for generic medicines.
Indoco Remedies Managing Director Aditi Panandikar said the approval reflected the organisation’s quality systems, qualified scientific and clinical teams, validated analytical capabilities and adherence to international regulatory and Good Clinical Practice requirements. She said the recognition strengthened the company’s ability to support customers in Brazil and other Latin American markets while expanding its international regulatory presence.
Headquartered in Hyderabad, AnaCipher provides services across bioavailability and bioequivalence studies, bioanalysis, clinical operations, regulatory affairs, data management and biostatistics. Its work supports pharmaceutical companies through different stages of clinical research and regulatory development.
The organisation has received approvals and accreditations from several regulatory agencies, including 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 in Oman.
Its project approvals also include regulatory authorities in Canada, China, South Africa and Iraq, including Health Canada’s TPD, China’s NMPA, South Africa’s MCC and the Ministry of Health in Iraq. The ANVISA approval expands AnaCipher’s ability to support clinical and bioanalytical requirements for pharmaceutical companies entering Brazil. It also provides customers with access to study facilities operating under the regulatory expectations of another major international market.
Indoco Remedies is a pharmaceutical company with operations spanning formulations and active pharmaceutical ingredients. With a presence in domestic and international markets, the company provides pharmaceutical products and research services to customers across several regions. Its CRO operations form part of its broader services for pharmaceutical development and regulatory submissions.
