Zydus Gets US Nod for Generic Schizophrenia Drug

11 Oct 2024 , 12:52 PM

On Thursday, Zydus Lifesciences said that the US health agency has given it the go-ahead to start producing its generic version of the schizophrenia treatment drug paliperidone extended-release tablets.

According to a regulatory filing by Zydus Lifesciences, the USFDA approved Paliperidone extended-release tablets with dosages of 1.5 mg, 3 mg, 6 mg, and 9 mg. It further stated that the tablets will be manufactured in the group’s SEZ, Ahmedabad, manufacturing facility.

According to the manufacturer, paliperidone extended-release tablets can be used to treat schizophrenia both acutely and as a maintenance medication. They can also be used to treat schizoaffective disorder acutely as a monotherapy or as an addition to mood stabilizers and/or antidepressants.

Zydus Group is located in Ahmedabad, India, and is ranked fourth among the Indian pharmaceutical businesses. The group has production and research facilities in five Indian states (Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim), as well as the United States and Brazil.

Zydus’ global business is well-established in the regulated markets of the United States, Europe (France and Spain), and the high-profile markets of Latin America and South Africa. It is also widely distributed in 25 additional emerging markets throughout the world.

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