APL-PR-USFDA-Products-Approval-Qtr-Ended-30062023.pdf

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: 3rd July, 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) (Tentative or Final) product approvals during the quarter ended 30 th June, 2023. With reference to our earlier communication dated 17th April, 2023 and the captioned subject, this is to inform the exchange that the Company has received various US Food & Drug Administration (USFDA) (Tentative or Final) Product Approvals during the quarter ended 30 th June, 2023. The summary statement giving brief of all product approvals received during the quarter ended 30th June, 2023 is enclosed for your information and records. Alembic has a cumulative total of 184 ANDA approvals (159 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 June, 2023. Product Name Approval Final/ Tentative Innovator Name Brand name Indication* Bepotastine Besilate Ophthalmic Solution, 1.5%. Final Bausch & Lomb Incorporated Bepreve Ophthalmi c Solution Bepotastine besilate ophthalmic solution 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Doxycycline Capsules, 40 mg, Tentative Galderma Laboratories, L.P. Oracea Capsules Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea. Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg. Final USWM, LLC Corgard Tablets Nadolol tablets are indicated for the long -term management of patients with angina pectoris and for the treatment of hypertension, to lower blood pressure. Carboprost Tromethamine Injection USP, 250 mcg/mL Single- Dose Vials. Final Pfizer, Inc. Hemabate Injection Carboprost tromethamine injection, USP sterile solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation. It is also indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. 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* Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multiple-Dose Vials. Final Genzyme Corporation Hectorol Injection Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis *Refer label for full indication.

The release as fetched from its publisher. alembicpharmaceuticals.com ↗