Drug Approval | January 17, 2025
FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure
Lonza to develop spray-dried formulations for an intranasally-delivered biologic for Iconovo at its Center of Excellence for bioavailability enhancement and inhaled delivery in Bend (US)
According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually
The certification marks a new chapter in Windlas Biotech’s growth trajectory,
The site’s GMP Certification has been successfully renewed
The project is set to attract significant manufacturing investments of approximately Rs. 10,500 crore and is also projected to create around 1 lakh direct and indirect jobs
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
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