RUBICON RESEARCH : US FDA INSPECTION OF MANUFACTURING FACILITY

• US FDA conducted an unannounced inspection of the company's manufacturing facility at Plot No. A-17, Special Economic Zone, Phase- II, Industrial Area, Pithampur, District Dhar, Madhya Pradesh. • The inspection took place from Monday, 29 June 2026 to Friday, 3 July 2026. • This was the first US FDA inspection of this facility since its acquisition by the company last year. • Upon conclusion, a Form 483 containing 2 observations was issued, which are procedural in nature and do not relate to data integrity. • The company is confident of working closely with the regulator to successfully conclude the evaluation. • Commercial operations at this facility are expected to ramp up from Q1 of calendar year 2027.

Rubicon Research Ltd

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