Drug Approval | November 07, 2022
Lupin receives tentative approval from USFDA for Drospirenone Tablets
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
The laboratory is equipped to perform high-volume diagnostic testing services
API platform to comprise of RA Chem Pharma, ZCL Chemicals and Avra Laboratories
Menon has over 41 years of diverse experience in some of the premier multinational and Indian companies in the chemical and power industry
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
Once the unit is made fully functional, it will help the company in increasing its API and intermediate production capacity
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