Sun Pharma receives USFDA approval for generic Glumetza

02 Aug 2016 Evaluate

Sun Pharmaceutical Industries’ subsidiary has received final approval from USFDA for its Abbreviated New Drug Application (ANDA) for generic version of Glumetza, Metformin Hydrochloride extended release tablets 500 mg and 1000 mg.

These Metformin Hydrochloride extended release tablets are therapeutic equivalents of Santarus Inc.’s Glumetza tablets. As per IMS MAT June 2016, these tablets have annual sales of approximately $1.2 billion in the US. The commercial launch of these tablets in the US is expected over the next few weeks.

Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

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