USFDA, Pharmaceuticals

USFDA gives nod to Alembic Pharma for its generic formulation to treat hypertension
Alembic has a cumulative total of 218 ANDA approvals (191 final approvals and 27 tentative approvals) from USFDA, it added.
Alembic Pharmaceuticals receives USFDA approval for Ivabradine Tablets
Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg and 7.
Alembic Pharma gets USFDA approval hypertension drug
Alembic Pharmaceuticals stated that it gained final FDA approval for the Diltiazem Hydrochloride Extended-Release capsules, which are used to treat hypertension.
USFDA gives nod to Alembic Pharma’s genetic formulation to treat heart failure
Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 145.3 million for twelve months ending September 2024 according to IQVIA.
Alembic Pharma gets USFDA nod for generic heart medication
Alembic Pharmaceuticals Limited announced today it has received final approval from the US Food & Drug Administration (USFDA) for its generic version of Diltiazem Hydrochloride Extended-Release Capsules. The approval covers five dosage strengths ...
Alembic Pharma gets USFDA nod for hypertension treatment drug
These capsules will be available in dosages of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, offering a generic alternative to the brand-name Cardizem CD capsules marketed by Bausch Health in the United States,
Alembic Pharmaceuticals gets USFDA nod for hypertension treatment capsules
Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Diltiazem Hydrochloride extended-release capsules indicated for the treatment of hypertension.
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Granules India Secures USFDA Approval for Andhra Facility
Granules India Ltd received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration ...
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USFDA says specific type of onions used in McDonald’s hamburgers likely linked to E. coli outbreak
Fresh-slivered onions used on McDonald’s Quarter Pounder hamburgers appear to be the likely source of a recent E. coli ...
Biocon shares surge 5% after USFDA classifies Bengaluru site as VAI
Biocon shares surged 5.4% after FDA classified its Bengaluru facility as Voluntary Action Indicated (VAI). The stock is up 47 ...
Biocon shares gain 9 per cent after USFDA inspection of Bengaluru unit
Shares of Biocon gained over 8 per cent after the US Food and Drug Administration (USFDA) classified its Bengaluru unit as ...
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If you bought soft cheese from this NJ store: toss it
Six types of brie cheese sold at Aldi stores in New Jersey and 11 other states have been recalled due to possible listeria ...
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Biocon shares surge 8.5% as USFDA classifies Bengaluru unit as VAI
Biocon Ltd shares jumped 8.4% on Monday after receiving a ‘Voluntary Action Indicated’ status from the USFDA for its ...