Alembic Pharma gets final USFDA nod for Bosentan tablets to treat pulmonary arterial hypertension Medical Dialogues Bureau25 Jan 2020 12:11 PM ISTNew Delhi: Alembic Pharmaceuticals (Alembic) on Friday said it has received final nod from US health regulator for Bosentan tablets, used for...
Alembic Pharma gets two USFDA observations for Karkhadi facility Medical Dialogues Bureau21 Jan 2020 12:50 PM ISTNew Delhi: Drugs maker, Alembic Pharma recently announced that the company's API facility located at Karkhadi has received Form 483 with two...
Alembic Pharma gets USFDA nod for spasticity drug Tizanidine MD bureau15 Jan 2020 10:15 AM ISTNew Delhi: Drug firm Alembic Pharmaceuticals on Wednesday said it has received final nod from the US health regulator for Tizanidine hydrochloride...
Alembic JV Aleor Derma gets USFDA nod for therapeutic equivalent of Clobex Spray Farhat Nasim4 Oct 2019 12:40 PM ISTClobetasol Propionate Spray, 0.05% is indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA)...
NPPA notices worth Rs 101 crore sent to Biocon, Lupin, Dr Reddys, others for skipping regulatory nod-Minister Medical Dialogues Bureau24 July 2019 12:16 PM ISTNPPA has so far issued demand notices for an amount of Rs 101 crore against defaulting companies. Out of this, an amount of Rs 5.56 crore has been...
Alembic Pharma gets USFDA nod for generic version of Uloric tablets Farhat Nasim2 July 2019 11:49 AM ISTThe approved product, Febuxostat tablet is therapeutically equivalent to the reference listed drug Uloric tablets of Takeda Pharmaceuticals USA, Inc....
Alembic Pharma gets USFDA nod for Clonazepam orally disintegrating tablets Farhat Nasim1 July 2019 12:25 PM ISTThe approval from the United States Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Clonazepam...
Alembic Pharma clears USFDA inspection at oncology unit in Panelav Farhat Nasim29 Jun 2019 10:02 AM ISTThis was a first scheduled inspection and Alembic Pharma passed the inspection without any Form 483 Observation.New Delhi: Alembic Pharmaceuticals...
Alembic Pharma gets USFDA nod for Bromfenac Ophthalmic Solution Farhat Nasim24 Jun 2019 12:25 PM ISTThe approved product, Bromfenac Ophthalmic Solution is therapeutically equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution,...
Alembic Pharma gets USFDA approval for Olopatadine Hydrochloride Ophthalmic Solution Farhat Nasim2 May 2019 4:04 PM ISTOlopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis.New...
Alembic Pharma gets USFDA nod toTeriflunomide tablets, Tobramycin ophthalmic solution Farhat Nasim22 April 2019 11:55 AM ISTTeriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis while Tobramycin ophthalmic solution is a...
Alembic Pharma JV Aleor gets USFDA nod for Clobetasol Propionate ointment Farhat Nasim6 March 2019 9:45 AM ISTThe company's JV, Aleor Dermaceuticals Ltd, has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug...
