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Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI
Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure
The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
The company has been issued ‘Form 483’ with two observations
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company will respond to these observations within the stipulated time period.
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
None of the observations are related to data integrity and management believes that they are addressable
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