News | February 10, 2023
Lupin receives approval from USFDA for Glycopyrrolate Injection USP
The approval for Glycopyrrolate clears the path for more internally manufactured injectable products
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
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
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 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
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
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