US FDA completes inspection at Stride Pharma’s Singapore facility

Strides Pharma’s formulation facility at Singapore underwent a US Food and Drug Administration (FDA) inspection that ended yesterday. The inspection was completed successfully with Zero 483 observations, a statement from Strides Pharma said.

The US is one of the key focus markets for Strides and the company has given a growth outlook of $250 million in FY23 for the US business. The company has set a target to launch approximately 20 new products every year in the US. It has 279 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with FDA of which 259 ANDAs have been approved and 20 are pending approval.

The company has a diversified manufacturing base with five FDA-approved facilities which are capable of catering to multiple dosage formats, including niche capabilities in controlled substances, hormones, nasal sprays, gels, modified release products and liquids.