News | February 11, 2023
Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules
The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product
The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product
The approval for Glycopyrrolate clears the path for more internally manufactured injectable products
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure
DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- and middle-income countries
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam
The company will engage with the agency to resolve the import alert at the earliest.
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
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