StockWatch
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Pharmaceuticals
Regulatory21 Oct 2026, 11:34 am

Smruthi Organics Unit II Passes ANVISA GMP Inspection

AI Summary

Smruthi Organics Ltd has received an inspection report from the Brazilian Health Regulatory Agency (ANVISA) for its Unit II in Solapur, Maharashtra. The inspection, conducted from June 7-11, 2026, classified the facility as "Complies with Good Manufacturing Practices with Corrective Action." The report indicates conditions for certification for the inspected active pharmaceutical ingredient. This is a significant step towards obtaining the final GMP certificate, although it has not yet been received. Further disclosures will be made upon receipt of the certificate.

Key Highlights

  • ANVISA inspection report received for Unit II.
  • Facility classified as 'Complies with GMP with Corrective Action'.
  • Conditions met for API certification.
  • Step towards obtaining final GMP certificate.
  • Final certificate not yet received.