This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
This innovative product eliminates two manufacturing steps and simplifies equipment setup
GL0034 is a novel, investigational glucagon-like peptide 1 receptor agonist (GLP-1RA) being studied for the treatment of type 2 diabetes and obesity
The company expects to capture a 10 per cent share in Spain’s $6.34 million meropenem market and consolidate its position in other European countries
Sajjan India Limited is looking for expansion, both organically and through acquisitions, to achieve the planned growth
Cullgen will have the option during the initial stages of clinical development to participate equally in the costs, profits and losses
Acquisition delivers industry-leading research capability, and strengthens pipeline with a novel candidate for ulcerative colitis, Crohn’s disease and other autoimmune conditions
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
Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.
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