Press Release USFDA Products Approval for Qtr ended 30th September 2023

ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123 Date: 2nd October, 2023 To, The Manager, Department of Corporate Services, BSE Limited P. J. Towers, Dalal Street, Fort, Mumbai – 400 001 BSE Scrip Code: 533573 To, The Manager, Listing Department, National Stock Exchange of India Ltd. ‘Exchange Plaza’, Bandra Kurla Complex, Bandra (E), Mumbai – 400 051 NSE Symbol: APLLTD Dear Sir/Madam, Sub: Alembic Pharmaceuticals receives various US Food & Drug Administration (USFDA) product approvals during the quarter ended 30th September, 2023. With reference the captioned subject, this is to inform the exchange that the Company has received various US Food & Drug Administration (USFDA) Product Approvals during the quarter ended 30th September, 2023. The summary statement giving brief of all product approvals received during the quarter ended 30th September, 2023 is enclosed for your information and records. Alembic has a cumulative total of 1 90 ANDA approvals (165 final approvals and 25 tentative approvals) from USFDA. We request you to kindly take the above on record. Thanking you, Yours faithfully, For Alembic Pharmaceuticals Limited Manisha Saraf Company Secretary Encl: A/a. ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123 Annexure Summarised Product Approval received during the quarter ended 30th September, 2023. Product Name Approval Final/ Tentative Innovator Name Brand name Indication* Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg. Final Upsher- Smith Laboratories, LLC. Chlorpromazin e Hydrochloride Tablets USP For the management of manifestations of psychotic disorders and treatment of schizophrenia. And other indications. Brimonidine Tartrate Ophthalmic Solution, 0.1%. Final AbbVie, Inc. Alphagan P Ophthalmic Solution Brimonidine tartrate ophthalmic solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open - angle glaucoma or ocular hypertension. Guanfacine Extended-Release Tablets USP, 1 mg, 2 mg, 3 mg, and 4 mg. Final Takeda Pharmaceuti cals U.S.A., Inc. Intuniv Extended- Release Tablets Guanfacine extended - release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications Erythromycin Tablets USP, 250 mg and 500 mg. Final Azurity Pharmaceuti cals, Inc. Erythromycin Tablets USP Erythromycin tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms. ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123 Product Name Approval Final/ Tentative Innovator Name Brand name Indication* Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5%. Final AbbVie, Inc. Combigan Ophthalmic Solution Brimonidine tartrate and timolol maleate ophthalmic solution 0.2% /0.5% 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 inadequatel y controlled IOP. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg. Final Bausch Health US, LLC. Librax Capsules Chlordiazepoxide hydrochloride and clidinium bromide capsules are indicated to control emotional and somatic fac tors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in treatment of the irritable bowel syndrome (irritable colon, spastic colon, muco us colitis) and acute enterocolitis. *Refer label for full indication.

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