In an exchange filing, the company said the current Good Manufacturing Practices (cGMP) inspection was conducted by the US Food and Drug Administration (USFDA) at the facility between 17 December and 23 December 2025. At the conclusion of the inspection, the regulator issued a Form 483 containing four observations.
The company clarified that the observations are procedural in nature and are not expected to have any impact on the supply of its commercial products. SPI will submit a comprehensive response to the USFDA within the stipulated timeframe and expressed confidence in addressing all the observations to the regulator’s satisfaction.
Strides Pharma further stated that it will keep the stock exchanges informed of any further developments in this matter. The official announcement was made on 24 December 2025, after market hours.
Strides Pharma Science is a global pharmaceutical company headquartered in Bangalore, India. It develops and manufactures a wide range of niche and technically complex pharmaceutical products.
The company’s consolidated net profit jumped 81.98% to Rs 131.52 crore on a 4.62% increase in revenue from operations to Rs 1,220.83 crore in Q2 Sept 2025 over Q2 Sept 2024.