The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2
Decision on EU marketing authorisation for this population expected by September 2024
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The inspection was concluded with two 483 observations
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
The product is bioequivalent and therapeutically equivalent to the reference listed drug
Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
The inspections concluded with no Form 483 observations or significant critical findings
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
The company will address these observations within the stipulated timeline
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