Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)
Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)
Injectafer is now the first and only intravenous (IV) iron replacement therapy indicated for adult patients with heart failure who have iron deficiency
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).
For the treatment of Superficial Femoral Artery
The product is expected to be launched in June 2023
This is the second US FDA GMP inspection of this facility within one year
Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States
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