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Alembic Pharma gets US FDA approval for timolol maleate expresspharma
October 27, 2020
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) timolol maleate ophthalmic gel forming solution, 0.25 per cent and 0.5 per cent.
Alembic Pharmaceuticals gets USFDA nod for Fenofibrate Capsules expresspharma
October 22, 2020
They are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia, mixed dyslipidemia and hypertriglyceridemia.
Alembic Pharma gets tentative US FDA nod for generic Rivaroxaban tablets expresspharma
June 23, 2020
The tablet is the generic of Janssen Pharmaceuticals's reference listed drug product Xarelto.
Alembic Pharma Q4 results: Net profit up 81 per cent to Rs 225 crore expresspharma
April 24, 2020
The company had posted a net profit of Rs 124 crore for the corresponding period of the previous fiscal, Alembic Pharmaceuticals said in a regulatory filing.
Alembic gets US FDA nod for generic ophthalmic solution expresspharma
April 22, 2020
The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Alcaftadine Ophthalmic Solution, Alembic Pharmaceuticals said in a regulatory filing.
Alembic Pharma gets EIR from US FDA for Karakhadi API facility expresspharma
March 18, 2020
Alembic Pharmaceuticals on Tuesday said it has received an EIR from the US health regulator after inspection of its active pharmaceutical ingredient (API) facility at Karakhadi in Gujarat.
Alembic Pharma receives four observations from USFDA for Panelav facility expresspharma
March 17, 2020
"The US Food and Drug Administration (USFDA) had conducted an inspection at Alembic Pharmaceuticals general oral solid formulation facility located at Panelav from 9-13 March, 2020," the drug firm said in a filing to the BSE.
Alembic Pharmaceuticals announces USFDA Final Approval for Travoprost Ophthalmic Solution USP, 0.004% firstwordpharma
December 24, 2019
Alembic Pharmaceuticals Limited (Alembic) today announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Travoprost Ophthalmic Solution USP, 0.004%.
Alembic Pharmaceuticals gets US FDA nod for ophthalmic solution expressbpd
December 11, 2018
The approved product is therapeutically equivalent to the reference listed drug product Patanol ophthalmic solution, 0.1 per cent, of Novartis Pharmaceuticals Corporation