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
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
Two biopharmaceutical experts join SK bioscience to strengthen the future strategies
Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions
Multilateral collaborations will serve to strengthen knowledge sharing to formulate framework for accessible, affordable, and quality healthcare
The company has been issued ‘Form 483’ with two observations
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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