Key Quantitative Figures and Dates

  • Inspection Period: 30th March, 2026 to 7th April, 2026
  • Approval Date: Received on 27th October, 2026 (date of press release)
  • Company Turnover: US$ 175 million
  • Employee Count: Over 6000 employees, including over 300 skilled scientists and field staff
  • Annual Prescriptions: More than 105 million prescriptions annually
  • Doctor Network: Over 2,39,000 doctors across various specialties

Parties Involved

  • Primary Entity: Indoco Remedies Limited (Scrip Code: 532612, NSE Code: INDOCO-EQ)
  • Subsidiary: AnaCipher (Clinical Research Organisation)
  • Regulatory Authority: National Health Surveillance Agency of Brazil (Agência Nacional de Vigilância Sanitária – ANVISA)
  • Company Representatives: Ramanathan Hariharan (Company Secretary & Lead Legal), Ms. Aditi Panandikar (Managing Director)

Approval Details and Authorization

AnaCipher received approval from ANVISA Brazil for both its clinical and bioanalytical facilities. With this approval, the CRO is authorized to:

  • Conduct Bioavailability & Bioequivalence studies for submission to Brazil
  • Provide associated bioanalytical support in accordance with ANVISA regulatory requirements

Management Commentary

Ms. Aditi Panandikar, Managing Director, stated that the approval reflects:

  • Robust quality management systems
  • Qualified scientific and clinical teams
  • Validated analytical capabilities
  • Adherence to international regulatory and Good Clinical Practice standards

She noted this reinforces the company's commitment to global quality standards and enhances ability to support pharmaceutical companies conducting studies for Brazil and expanding across Latin America.

Company Background - Indoco Remedies Limited

Indoco is a fully integrated, research-oriented pharmaceutical company with:

  • 10 manufacturing facilities (6 for FDFs, 4 for APIs)
  • State-of-the-art R&D Centre
  • CRO facility (AnaCipher)
  • Facilities approved by most Regulatory Authorities including USFDA and UK-MHRA
  • 8 domestic marketing divisions
  • Strong brand portfolio across multiple therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infectives, Stomatologicals, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gynaecology
  • Top brands include: Cyclopam, Febrex Plus, ATM, Rexidin M, Karvol Plus, Oxipod, Cital, Sensodent-K, Cital-Uti, Dropizin, Dentogel, Oxipod CV, Turbocort, Febrex, Cloben G, Tuspel LS, Noxa, MCBM 69
  • International tie-ups with large generic companies across the globe

AnaCipher Background

AnaCipher is a clinical research organisation headquartered in Hyderabad, India providing:

  • Bioequivalence and bioavailability studies
  • Bioanalysis
  • Clinical operations
  • Regulatory affairs
  • Data management
  • Biostatistics services

Existing Regulatory Accreditations

AnaCipher has been accredited by:

  • CDSCO
  • USFDA
  • WHO
  • EMA
  • UKMHRA
  • MoH-Oman

Project-based approvals have been received from:

  • TPD-Canada
  • NMPA - China
  • MCC-South Africa
  • MoH-Iraq

Strategic Impact

The ANVISA Brazil approval further strengthens AnaCipher's international regulatory footprint and reinforces its position as a trusted partner for global clinical research programmes.