Zydus Cadila gets USFDA nod for generic Syprine, Tracleer drugs

Pharmaceutical manufacturer Zydus Cadila said it received approval from the United States Food and Drug Administration for the sales of a generic version of Valeant Pharmaceuticals’ Syprine capsules and a generic version of Actelion Pharmaceuticals’ Tracleer tablets.

Trientine Hydrochloride capsules are chelating agents used for the treatment of Wilson’s disease, a genetic metabolic defect that causes excess copper to build up in the body. It works by removing copper from the blood.

Bosentan tablets, a generic version of Tracleer pills, are used to treat pulmonary arterial hypertension or high blood pressure in the lungs. This condition is thought to be caused by increased levels of a certain natural substance called endothelin—l. Bosentan pills block the effects of endothelin—1, which helps lower blood pressure in the lungs, slow the worsening of symptoms from the disease and improves ability to exercise.

Both medications will be manufactured at Zydus’ manufacturing facility in Ahmedabad.

With the latest nods, Zydus has so far received 265 approvals and filed over 350 application for the sales of its generic drugs.

Headquartered in Ahmedabad, Zydus Cadila has manufacturing sites and research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim and in the United States and Brazil.