Alembic Pharmaceuticals receives USFDA EIR for API-III facility in Gujarat
The inspection at the Karakhadi-based manufacturing site was conducted by the USFDA from 17 to 21 March 2025
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US FDA
Trump’s move to transform US pharma manufacturing raises doubts over its effectiveness: GlobalData
GlobalData analysts highlight uncertainty around new FDA directives as pharma giants ramp up US-based manufacturing investments…
What US FDA’s new surprise foreign inspections plan means for India
Pharma companies exporting to the US should now rightly be on guard and start preparing for the inevitable “knock on the factory…
US Health Dept may ask fired staff to keep working, reinstate others
Some laid-off staff may be asked to work until June; CDC programme reinstated as HHS adjusts course following mass federal health…
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
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