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Aurobindo Pharma has received final approval from the US Food & Drug Administration to manufacture Guaifenesin extended-release tablets, 600 mg and 1,200 mg. The product is expected to launch during the fourth quarter of FY20. The product has an estimated market size of $301 million for the 12 months ending July 2019. Aurobindo now has a total of 419 ANDA approvals (392 final approvals, including 21 from Aurolife Pharma LLC and 27 tentative approvals) from the USFDA.
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