INDIA—Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market its generic version of Paliperidone extended-release tablets, which are used to treat schizophrenia.
According to a regulatory filing by the company, the USFDA has given the green light for Paliperidone extended-release tablets in four strengths: 1.5 mg, 3 mg, 6 mg, and 9 mg.
These tablets are set to be manufactured at Zydus Lifesciences’ production facility located at the Special Economic Zone (SEZ) in Ahmedabad, India.
The company noted that Paliperidone extended-release tablets are indicated for several therapeutic purposes, including the acute and maintenance treatment of schizophrenia, as well as the acute treatment of schizoaffective disorder, either as a standalone therapy or in combination with mood stabilizers and/or antidepressants.
This approval allows Zydus to expand its portfolio of treatments for mental health conditions in the U.S. market.
This recent approval follows other regulatory updates for the company, whereby Zydus Lifesciences announced that it had received an Establishment Inspection Report (EIR) from the USFDA.
This report came after an inspection of its transdermal patch manufacturing facility in Pharmez, Ahmedabad, conducted between July 15 and 19, 2024.
The inspection resulted in a classification of ‘voluntary action indicated’ (VAI), which suggests that while some issues were noted, they do not require immediate regulatory action.
However, the company has faced some regulatory challenges in recent months.
In August 2024, the FDA issued a warning letter to Zydus Lifesciences concerning its drug manufacturing facility in Jarod, Gujarat.
This followed an inspection in April 2024, during which the FDA identified deficiencies related to Current Good Manufacturing Practices (CGMP), specifically citing concerns about cross-contamination, particulate contamination, and substandard aseptic procedures.
These findings highlight the need for the company to address critical manufacturing process issues to meet regulatory standards.
Despite these setbacks, the approval of the Paliperidone tablets is a positive development for Zydus Lifesciences.
According to data from IQVIA MAT, as of July 2024, Paliperidone extended-release tablets had annual sales of approximately US$47.1 million in the United States.
This approval enables Zydus to capture a share of this market, providing a more affordable option for patients who rely on this medication for managing schizophrenia and schizoaffective disorder.
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