Drug Approval | February 24, 2023
SERDA therapeutics submits IND for wound debridement agent
Clinical studies are expected to start in Q2 2023.
Clinical studies are expected to start in Q2 2023.
Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
The agreement between Eli Lilly and Janssen was established to allow the two companies to share resources for the goal of accelerating the evaluation of the respective companies’ assets, mirikizumab and Tremfya (guselkumab).
India formulation sales at Rs. 3,391.9 crore, up 7.1% over Q3 last year
The only robotic-arm assisted surgical device to conduct joint replacement with accuracy and better clinical outcomes
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection
Granules now have a total of 53 ANDA approvals from USFDA
The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid
The company will submit an action plan on the observations and will engage with US FDA for next steps.
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