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ALEMBIC USFDA
Alembic Pharma gets USFDA tentative nod for generic prostate cancer drugAlembic Pharmaceuticals has secured tentative approval from the USFDA for its generic version of Darolutamide tablets, targeting prostate c...14 May, 2026, 04.32 PM IST- Alembic Pharma gets USFDA nod for generic cancer, arthritis injectionAlembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic methotrexate injection, used t...16 Apr, 2026, 01.06 PM IST
- Alembic Pharmaceuticals gets USFDA nod for anti-depressant drugThe approved product is therapeutically equivalent to the reference listed drug product Norpramin tablets of Validus Pharmaceuticals LLC.08 Jul, 2021, 01.53 PM IST
- Alembic Pharma gets five observations from USFDA for Gujarat facilityAs per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any cond...08 Feb, 2021, 12.15 PM IST
- Alembic Pharma gets USFDA nod for bipolar disorder treatment drugIn a regulatory filing, Alembic Pharmaceuticals said it has received approval from the US Food and Drug Administration (USFDA) for its abbr...11 Dec, 2020, 11.49 AM IST
- Alembic Pharma gets tentative USFDA nod for breast cancer treatment drug"The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (AND...09 Nov, 2020, 11.22 AM IST
- Alembic Pharma gets VAI classification from USFDA for its Panelav facilityAs per the USFDA, VAI classification means that though objectionable conditions or practices were found, the agency is not prepared to take...04 May, 2020, 05.01 PM IST
- Alembic Pharma gets USFDA nod for Febuxostat tabletsShares of Alembic Pharmaceuticals were trading 3.86 per cent higher at Rs 523 apiece.02 Jul, 2019, 10.56 AM IST
- Alembic Pharma gets USFDA nod for 2 generic productsThe product is generic version of Sanofi-Aventis US LLC's Aubagio tablets in the same strengths.22 Apr, 2019, 03.13 PM IST
- Alembic Pharma gets USFDA nod for erectile dysfunction drugThe company currently has a total of 89 ANDA approvals (77 final approvals and 12 tentative approvals) from USFDA, it added.27 Mar, 2019, 01.51 PM IST
- Alembic Pharma gets USFDA nod for Alembic PharmaThe approved product is therapeutically equivalent to AstraZeneca Pharmaceuticals' Xylocaine ointment, 5 per cent.26 Nov, 2018, 12.52 PM IST
- Alembic Pharma gets tentative USFDA nod for ophthalmic solutionAlembic said it is currently in litigation with Allergan in District Court of New Jersey and the launch of this product will depend on the ...06 Aug, 2018, 12.33 PM IST
- Alembic Pharma surges 20% on USFDA nod for anti-depression drugBupropion Hydrochloride tablets USP have an estimated market size of $37 million.11 Jun, 2018, 02.03 PM IST
- Alembic Pharma gets US FDA nod for anti-migraine drug"The company has received approval from the USFDA for its Abbreviated New Drug Application for Zolmitriptan Orally Disintegrating Tablets, ...05 Dec, 2016, 11.27 AM IST
- Alembic Pharma gets USFDA nod for hypertension tabletsUSFDA approves Alembic Pharma's Telmisartan and Amlodipine tablets, generic version of Boehringer Ingelheim Pharmaceuticals Inc's Twynsta t...18 Nov, 2016, 05.52 PM IST
- Alembic Pharma says plants successfully inspected by USFDAThe company, however, did not provide any details about the observations it has received from the United States Food and Drug Administratio...30 Jun, 2016, 11.48 AM IST
- Alembic Pharma gets 4 USFDA observations for Panelav plantDrug firm Alembic Pharmaceuticals today said it has received four observations from the US health regulator after the inspection of Panelav...18 Apr, 2016, 06.34 PM IST
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