Drug Approval | March 13, 2023
Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division
The company will be submitting the responses to US FDA observations within stipulated timeline
The company will be submitting the responses to US FDA observations within stipulated timeline
Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.
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
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