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Strides Pharma Science Limited (Strides) announced that its step‐down wholly‐owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has entered into a definitive asset transfer and licensing agreement with Pharmaceutics International, Inc.(Pii) to acquire 18 ANDAs for the US market.
With access to these products, Strides will significantly expand its niche offerings on its front end, which has grown multi‐folds to attain a quarterly revenue size of $66 million. Of the 18 products successfully developed by Pii with their Pharmaceutics Know How™, 11 are currently approved by USFDA while the remaining seven (7) products are submitted and are under different stages of review with the Agency.
Out of the 11 approved ANDAs, Strides is currently commercializing two (2) ANDAs with product supply from Pii, while the remaining approved ANDAs will be transferred to Strides’ global manufacturing facilities and commercialized over the next 18‐24 months.
In addition, Strides will also have exclusive marketing rights for Levothyroxine Sodium Tablets, a narrowniche micro dose product indicated as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism with a market opportunity of $2.5 billion. Pii has developed the product(s) for submission as ANDA(s) and has completed the bioequivalence studies for four (4) reference listed drugs ‐ Synthroid®, Unithroid®, Levoxyl®, and Thyro‐tabs® covering the entire addressable market opportunity
