Strides Pharma passes US FDA inspection at Singapore facility

Published: 10-Aug-2022
Regulatory Finance Pharmaceutical

The global pharma company has completed the inspection with zero 483 observations

Strides Pharma Science has announced that its formulation facility in Singapore underwent a US FDA inspection that ended in early August 2022.

The inspection was completed successfully with Zero 483 observations.

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

The company has a diversified manufacturing base with 5 USFDA-approved facilities which are capable of catering to multiple dosage formats including niche capabilities in controlled Substances, Hormones, Nasal Sprays, Gels, Modified Release products, Liquids.

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  • US Food and Drug Administration (FDA)
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