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Drug Approval | February 10, 2025
Briefs: Caplin Point Laboratories, Hikal and Cipla
Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
During the quarter, US formulations revenue decreased by 2.3% YoY to Rs. 3,671 crore.
Itolizumab achieved key secondary endpoint of endoscopic remission of 16.7% compared to 16.7% for adalimumab and 6.7% for placebo
Consolidated manufacturing volumes for Q3 FY25 remained stable at 132,187 KL, while for 9M FY25 it stood at 372,505 KL
This innovative formulation combines cutting-edge ingredients is a first of its kind in India to have a Duo-Lipo technology
Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)
The company is committed to revolutionizing API development by advancing synthesis and analytical processes that enhance quality and impact lives
The inspection was carried out from January 28 to February 1, 2025
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years
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