Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
UTD2 is the world's first oral epothilone microtubule inhibitor
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
The new API plant is set up to meet all domestic and international regulatory standards and will manufacture niche molecules that have a global requirement
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
Agreement provides customers in the majority of Europe* access to supply through Univar Solutions distribution network
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