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
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.
The company has been issued ‘Form 483’ with two observations
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)
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