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  • 6 medicines of Alembic...

6 medicines of Alembic Pharma received USFDA nod during Q2FY24

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-10-04T12:30:14+05:30  |  Updated On 13 Oct 2023 4:19 PM IST
Alembic Pharma arm incorporates wholly-owned subsidiary in USA
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Mumbai: Alembic Pharmaceuticals Limited has announced that it has received US Food & Drug Administration (USFDA) approvals on six of its Abbreviated New Drug Application (ANDA) during Q2FY24. The Company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, Brimonidine Tartrate Ophthalmic Solution, 0.1%, Guanfacine Extended-Release Tablets USP, 1 mg, 2 mg, 3 mg, and 4 mg, Erythromycin Tablets USP, 250 mg and 500 mg, Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg.

Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg of Upsher-Smith Laboratories, LLC., is to manage the symptoms of psychotic disorders and treatment of schizophrenia, control nausea and vomiting, relief of restlessness and apprehension before surgery, acute intermittent porphyria, adjunct in the treatment of tetanus, to control the manifestations of the manic type of manic-depressive illness and for relief of intractable hiccups.

Brimonidine Tartrate Ophthalmic Solution, 0.1% with the brand name Alphagan P Ophthalmic Solution is from the innovator AbbVie, Inc. The medication is indicated to lower elevated intraocular pressure (IOP) in patients suffering with open-angle glaucoma or ocular hypertension.

Guanfacine Extended-Release Tablets USP, 1 mg, 2 mg, 3 mg, and 4 mg by Takeda Pharmaceuticals U.S.A., Inc. and with brand name Intuniv Extended-Release Tablets is indicated for individuals suffering from Attention Deficit Hyperactivity Disorder (ADHD). The tablets can be used alone or alongside stimulant medications.

Erythromycin Tablets USP, 250 mg and 500 mg by Azurity Pharmaceuticals, Inc. is for treatment of various infections caused by certain microorganisms.

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% by AbbVie,Inc. is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The brand name for the product is Combigan Ophthalmic Solution.

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg with the brand name Librax Capsules by Bausch Health US, LLC. are indicated to control emotional and physical factors that can cause gastrointestinal disorders. These capsules may also be used as additional treatments to help in peptic ulcer and in irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

Read also: Alembic Pharma successfully completes ANVISA, Brazil GMP audit for API-III facility at Karakhadi

alembic pharmaalembic pharma newsUSFDAChlorpromazine Hydrochloride TabletsBrimonidine Tartrate Ophthalmic SolutionGuanfacine Extended-Release TabletsErythromycin TabletsBrimonidine Tartrate and Timolol Maleate Ophthalmic SolutionChlordiazepoxide Hydrochloride and Clidinium Bromide CapsulesschizophreniaAlphagan P Ophthalmic Solutionabbvieglaucomaocular hypertensionTakeda PharmaIntuniv Extended Release TabletsAttention Deficit Hyperactivity Disorder
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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