Key Event Details

The UK Medicines and Healthcare products Regulatory Agency (MHRA) conducted a current Good Manufacturing Practices (cGMP) inspection at Indoco Remedies Limited's manufacturing facility at Plant I (solid oral dosage form) located at Goa. The inspection took place from 07th September, 2026 to 09th September, 2026. The inspection concluded with no critical or major observations.

Facility Details and Regulatory Approvals

The inspected facility manufactures solid dosages and liquid dosages and holds multiple regulatory approvals:

  • USFDA approval for solid dosages, creams and capsules
  • TGA-Australia approval for solid dosages, liquid orals, creams and ointments
  • EU Malta approval (MMA - Malta Medicine Authority) for solid dosages
  • WHO-GMP approval
  • Successful audit by SAHPRA for solid dosages

Business Significance

According to Ms. Aditi Panandikar, Managing Director, the plant has been consistently catering to regulated markets including UK, Europe, South Africa, New Zealand, Australia and Canada for several years. The facility is expected to contribute approximately 30% of the company's total international business.

Management Commentary

Ms. Aditi Panandikar stated: "The successful completion of the UKMHRA cGMP inspection with no critical or major observations is a strong validation of our robust quality systems. This further testifies our unwavering commitment to Good Manufacturing Practices and world class quality standards. The accolade not only reinforces the trust our global partners place in us, but strengthens our ability to serve patients worldwide."

Company Background

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

  • Turnover of US$ 175 million
  • Over 6000 employees including over 300 skilled scientists and field staff
  • 10 manufacturing facilities (6 for FDFs and 4 for APIs)
  • State-of-the-art R&D Centre and CRO facility
  • Facilities approved by most Regulatory Authorities including USFDA and UK-MHRA
  • Generates more than 109 million prescriptions annually from over 2,50,000 doctors
  • 10 domestic marketing divisions with strong brand portfolio across therapeutic segments

Filing Details

  • Disclosure made to: National Stock Exchange of India Limited and Bombay Stock Exchange Limited