The products will be manufactured at the company’s facility in Bengaluru and conversion of this tentative approval to a full approval is expected upon expiry of the constraining patents.
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The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with the USFDA, of which 230+ ANDAs have been approved. The company is eyeing around 60 new product launches over the next three years in the US.