Last Updated on December 31, 2023 by The Health Master
Strides Pharma’s formulation facility in Singapore underwent a US Food and Drug Administration (USFDA) inspection that ended yesterday.
The inspection was completed successfully with Zero observations on Form 483, 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 a 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 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.
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