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
Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
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's long-term strategy is on science, technology and innovation and the company's strategy relating to this is on track
Gland Pharma Q2 FY2023 consolidated net profit up at Rs. 241.24 Cr
Oncodesign Services (ODS ), with 600 clients in 33 countries and 227 employees worldwide, provides services from target identification to hit-to-lead and lead optimization through to IND filing.
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Pluvicto and Scemblix launches are progressing well and we are awaiting data in earlier lines of therapy.
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