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)
The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient and finished drug at its facilities approved by USFDA
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