Strides receives FDA warning letter and defers 10 ANDAs
Strides Pharma Science, an Indian-based generics manufacturer, formerly known as Strides Shashun, announced the news to investors today, after having previously stated that the Puducherry site required action on May 6, 2019.
The company noted that the warning letter from the US Food and Drug Administration (FDA) would lead to 10 abbreviate new drug applications (ANDAs) pending approval to be deferred until after the site is reclassified. However, six ANDAs currently manufactured at the site would not be impacted.
In a statement, the company said that “[It] is committed to the highest standards of quality and compliance and will work collaboratively with the FDA to resolve all issues addressed in the warning letter.”
The US market is a ‘strategic geography’ into which Strides sells prescription, OTC and consumer health products, according to the company.
Its range of products focuses on niche, ‘low volume’ and ‘low competition’ products, delivered through modified release technology, soft-gel capsules, topicals and liquids.
Despite the warning letter, the company maintains its growth guidance for the US market.
Last year, Strides was on the receiving end of a Form 483 for the FDA for its Bangalore facility, which produces potassium chloride extended-release tablets.