Successful completion of US FDA inspection of Strides' Singapore facility
Indian drugmaker Strides Pharma Science (BSE: 532531) today announced that its formulation facility at Singapore underwent a US Food and Drug Administration (FDA) inspection that ended on August 8, 2022.
The inspection was completed successfully with Zero 483 observations. Strides notes that the USA is one of the key focus markets for Strides and the company has given a growth outlook of $250 million in fiscal year 2023 for the US business.
The company has set a target to launch ~20 new products every year in the USA. The company has 279 cumulative abbreviated new drug application (ANDA) filings (including recently acquired portfolio from Endo at Chestnut Ridge) with the US FDA of which 259 ANDAs have been approved and 20 are pending approval.
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