Drug Approval | November 21, 2022
Aurobindo Pharma receives 10 observations for Unit IX
The company had responded to the agency and carried out the required corrective actions.
The company had responded to the agency and carried out the required corrective actions.
Formulation revenue decreased by 7.6% YoY to Rs. 4,770 crore whereas in Q2 FY23, API business posted a growth of 24.2% YoY with revenue of Rs. 969.4 crore
Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.
Investment in R&D was Rs. 337.6 crore (8.3% of sales) for Q2 FY2023 as compared to Rs. 330 crore (8.2% of sales) for Q2 FY2022.
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
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint
MoCD Type A is a rapidly progressive autosomal recessive inborn error of metabolism resulting in toxic sulfite levels causing neurologic sequelae
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