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New Delhi, Zydus Lifesciences Ltd on Friday stated it has acquired ultimate approval from the US well being regulator to fabricate and market its generic Isosorbide Mononitrate extended-release tablets used to forestall chest ache in sufferers with a sure coronary heart situation. The approval by the US Meals and Drug Administration (USFDA) is to fabricate and market Isosorbide Mononitrate Prolonged-Launch, of strengths 30 mg, 60 mg, and 120 mg, Zydus Lifesciences stated in a regulatory submitting.
Isosorbide mononitrate is used to forestall chest ache (angina) in sufferers with a sure coronary heart situation, coronary artery illness, it added.
The product might be manufactured on the group’s formulation manufacturing facility at Ahmedabad SEZ, the corporate stated.
Isosorbide Mononitrate extended-release tablets 30 mg, 60 mg, and 120 mg had annual gross sales of USD 47 million within the US, Zydus stated citing IQVIA December 2023 knowledge.
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