Granules India’s Gagillapur facility classified as “Official Action Indicated” following US FDA…
Company responds to observations and initiates improvements in collaboration with external experts
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Browsing Tag
US FDA
Lupin receives tentative U.S. FDA approval for Raltegravir tablets
Lupin may secure 180-day exclusivity to market a generic version of Merck’s Isentress HD
Alembic secures USFDA approval for Diltiazem Hydrochloride extended-release capsules
Approval covers 120 mg, 180 mg, and 240 mg formulations for the treatment of hypertension and chronic stable angina
US FDA approves Eli Lilly’s drug for eczema
Eli Lilly’s Ebglyss, a new eczema treatment, gains US FDA approval for patients 12 and older, offering a monthly dosing option and…
FDA issues warning letters to two Chinese firms over data integrity concerns
Agency flags nonclinical testing data and animal care violations, review ongoing
Lupin receives U.S. FDA approval for Brimonidine Tartrate Ophthalmic Solution
Lupin to market generic version of AbbVie's Alphagan P for elevated intraocular pressure, manufactured at its Pithampur facility
US FDA approves AstraZeneca’s non-small cell lung cancer treatment
Imfinzi gains expanded use, and AstraZeneca’s shares rise after a priority review for small cell lung cancer
Atul Bioscience receives US FDA EIR with zero observations for Ambernath facility
Atul Bioscience’s Ambernath manufacturing site earns US FDA approval with zero 483 observations, highlighting the company’s…
Dr Reddy’s Labs gets US FDA clearance: Visakhapatnam facilities classified as VAI
USFDA concludes inspection of Dr Reddy's Visakhapatnam units with Voluntary Action Indicated status
Granules India gains ANDA approval for Trazodone tablets
The current annual US market for Trazodone tablets is approximately $128 million, according to MAT Jun 2024, IQVIA/IMS Health