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Drug firm Zydus Cadila on Tuesday said it has received final nod from the USFDA to market generic Bosentan tablets and Trientine Hydrochloride capsules in the US.
The company has received final approval from the US heath regulator to market Bosentan tablets USP in strengths of 62.5 mg and 125 mg and Trientine Hydrochloride capsules USP in the strength of 250 mg, Zydus Cadila said in a statement. “Both products will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad,” it added.
While Bosentan tablets are generic version of Tracleer tablets, Trientine Hydrochloride capsules are generic version of Syprine capsules, Zydus Cadila said. Bosentan is used to treat high blood pressure in the lungs, it added. Trientine works by removing copper from the blood. It is used to treat Wilson’s disease, a genetic metabolic defect that causes excess copper to build up in the body. It is recommended to patients who cannot take penicillamine, Zydus Cadila said.
The group now has 265 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added. Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 322 per scrip on BSE, down 1.80 per cent from the previous close.
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