BSECompany Update20h ago · 30 Oct 2026, 06:29 pm

Alembic Pharmaceuticals Limited receives USFDA Final Approval for Venetoclax Tablets, 10mg, 50 mg and 100 mg.

Alembic Pharmaceuticals Ltd · 533573

✦ AI Summary▲ PositiveOrder Win

Alembic Pharmaceuticals Ltd has received USFDA Final Approval for Venetoclax Tablets, 10mg, 50mg, and 100mg, which are indicated for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Analysis Scores

Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment9/10

✦ Ask a Question

Ask anything about this announcement — AI will answer based on the filing content.

0/500

Full Announcement

Alembic Pharmaceuticals Ltd - 533573 - Announcement under Regulation 30 (LODR)-Press Release / Media Release

Attachments (1)

📄

8bf8fab3-78b3-4403-919b-527e7259db9e.pdf

pdf

Download →
View document text
30th October, 2026 To, To, The Manager, The Manager, Department of Corporate Services, Listing Department, BSE Limited National Stock Exchange of India Ltd. P. J. Towers, Dalal Street, ‘Exchange Plaza’, Bandra Kurla Complex, Fort, Mumbai – 400 001 Bandra (E), Mumbai – 400 051 BSE Scrip Code: 533573 NSE Symbol: APLLTD Dear Sir/Madam, Sub: Alembic Pharmaceuticals Limited receives USFDA Final Approval for Venetoclax Tablets, 10 mg, 50 mg and 100 mg. With reference to the captioned matter, this is to inform the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for its Abbreviated New Drug Application for Venetoclax Tablets, 10 mg, 50 mg and 100 mg. A press release being issued in this regard is enclosed herewith. We request you to kindly take the same on record. Thanking you, Yours faithfully, For Alembic Pharmaceuticals Limited Chirag K. Shukla 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 : alembic@alembic.co.in ● CIN : L24230GJ2010PLC061123 PRESS RELEASE 30th October, 2026 Vadodara, India Alembic Pharmaceuticals Limited receives USFDA Final Approval for Venetoclax Tablets, 10 mg, 50 mg and 100 mg. Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Venetoclax Tablets, 10 mg, 50 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Venclexta Tablets, 10 mg, 50 mg, and 100 mg, of AbbVie Inc. (AbbVie). Venetoclax tablets are indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax tablets are also indicated, in combination with azacitidine, or decitabine, or low-dose cytarabine, for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Refer label for a detailed indication and usage. Alembic was a first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Venetoclax Tablets, 10 mg, 50 mg and 100 mg. Therefore, with this approval, Alembic may be eligible for 180 days of generic drug exclusivity. According to IQVIA, Venetoclax tablets, 10 mg, 50 mg and 100 mg, had an estimated market size of US $1,584 million in the United States for twelve months ending June 2026. Alembic has a cumulative total of 248 ANDA approvals (228 final approvals and 20 tentative approvals) from the USFDA. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a field force of over 5,800 are well recognized by doctors and patients. Information about the Company can be found at www.alembicpharmaceuticals.com; (Reuters:ALEM.NS) (Bloomberg:ALPM) (NSE:APLLTD) (BSE:533573) For more information, contact: Isha Lamba Phone: +91 22-66951652 Email: isha.lamba@alembic.co.in ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : alembic@alembic.co.in ● CIN : L24230GJ2010PLC061123