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
Dr. Mandaviya urged the stakeholders to capitalize on the current opportunities
The product is expected to be launched in June 2023
The company has reported total income of Rs. 11303.95 crores during the period ended March 31, 2023
The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans
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
Subscribe To Our Newsletter & Stay Updated
