Zydus receives USFDA nod for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg
Ahmedabad: Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9
mg (USRLD: Invega Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg).
Paliperidone extended-release tablets are indicated for the acute and maintenance treatment of
schizophrenia, acute treatment of schizoaffective disorder as monotherapy and acute treatment
of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants.
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at
SEZ, Ahmedabad.
Read Also: Zydus Lifesciences bags tentative USFDA nod for Enzalutamide Tablets for prostate cancer
(IQVIA MAT July 2024).
The group now has 400 approvals and has so far filed over 465* ANDAs since the
commencement of the filing process in FY 2003-04.
Read Also: USFDA issues EIR for Zydus Lifesciences Pharmez transdermal patch manufacturing facility
