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USFDA ALEMBIC PHARMA
Alembic, Aurobindo recall drugs in US marketAlembic Pharmaceuticals and Aurobindo Pharma are recalling products in the US due to manufacturing problems. Alembic is recalling 82,400 bo...21 Aug, 2023, 05.03 PM IST- Alembic Pharma gets USFDA nod for bipolar depression drugThe approved product is therapeutically equivalent to the reference listed drug product (RLD) Latuda tablets of Sunovion Pharmaceuticals In...14 May, 2021, 02.22 PM IST
- Alembic Pharma's JV Aleor Dermaceuticals gets American regulator nod for Testosterone GelAleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its ANDA for its abbreviated new drug...04 Mar, 2021, 12.57 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 JV gets USFDA nod for antifungal topical solutionAleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application ...22 Oct, 2020, 12.02 PM IST
- Alembic Pharma gets USFDA nod for cholesterol lowering drugIn a regulatory filing, Alembic Pharma said "it has received final approval from the US Food and Drug Administration (USFDA) for its abbrev...21 Oct, 2020, 12.05 PM IST
- Alembic Pharma's JV gets USFDA nod for skin disorder treatment drugDesonide lotion is low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of cortic...25 Aug, 2020, 01.05 PM IST
- Alembic Pharma gets USFDA nod for generic acne treatment gelAlembic Pharmaceuticals on Friday said its joint venture has received nod from the US health regulator for generic Adapalene gel used for t...19 Jun, 2020, 02.48 PM IST
- Alembic Pharma gets USFDA nod for generic chronic iron overload treatment tabletsThe company has received the final approval from the United States Food & Drug Administration (USFDA) for its abbreviated new drug applicat...16 Jun, 2020, 01.32 PM IST
- Alembic Pharma JV gets USFDA nod for plaque psoriasis treatment drugAlembic has a cumulative total of 103 ANDA approvals (91 final approvals and 12 tentative approvals) from USFDA.04 Oct, 2019, 11.42 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 receives EIR from USFDAUSFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determine...15 Jun, 2018, 11.13 AM 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
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