News | June 21, 2023
DGCI grants Emergency Use Authorisation to Gennova mRNA Covid booster vaccine
The booster vaccine can be administered safely to individuals who have received two doses of either Covaxin or Covishield
The booster vaccine can be administered safely to individuals who have received two doses of either Covaxin or Covishield
The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma
Laurus will also provide funding for the clinical trials and will launch these products in India and emerging markets
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
Acquisition delivers industry-leading research capability, and strengthens pipeline with a novel candidate for ulcerative colitis, Crohn’s disease and other autoimmune conditions
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
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
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
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