NSEPress Release21h ago · 30 Oct 2026, 06:28 pm
Press Release
Alembic Pharmaceuticals Limited · APLLTD
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Alembic Pharmaceuticals Limited has received USFDA Final Approval for Venetoclax Tablets, 10 mg, 50 mg and 100 mg, which are therapeutically equivalent to the reference listed drug product Venclexta Tablets, 10 mg, 50 mg, and 100 mg of AbbVie Inc. This approval may make Alembic eligible for 180 days of generic drug exclusivity and has a cumulative total of 248 ANDA approvals from the USFDA.
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Alembic Pharmaceuticals Limited receives USFDA Final Approval for Venetoclax Tablets, 10 mg, 50 mg and 100 mg.
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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