Leading pharma major, Sun Pharmaceutical Industries Ltd has said that one of its subsidiaries has received final approval from US FDA 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 USD 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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