BSECompany Update1d ago · 28 Jul 2026, 01:23 pm
Alembic Pharmaceuticals Limited receives USFDA Final approval for Prucalopride Tablets, 1 mg and 2 mg.
Alembic Pharmaceuticals Ltd · 533573
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Alembic Pharmaceuticals Ltd has received USFDA final approval for Prucalopride Tablets, 1 mg and 2 mg, a treatment for chronic idiopathic constipation in adults, with an estimated market size of $100 million.
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Alembic Pharmaceuticals Ltd - 533573 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
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Date: 28th July, 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 Prucalopride Tablets,
1 mg and 2 mg.
With reference to the captioned subject, this is to inform the exchange that the Company has
received US Food & Drug Administration (USFDA) Final Approval for Prucalopride Tablets, 1 mg
and 2 mg.
Please find enclosed herewith our press release.
We request you to kindly take the same 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 : alembic@alembic.co.in ● CIN : L24230GJ2010PLC061123
PRESS RELEASE
28th July, 2026 Vadodara, India
Alembic Pharmaceuticals Limited receives USFDA Final Approval for Prucalopride Tablets, 1
mg and 2 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) Prucalopride Tablets, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent
to the reference listed drug product (RLD), Motegrity Tablets, 1 mg and 2 mg, of Takeda
Pharmaceuticals USA Inc. Prucalopride tablets are serotonin-4 receptor agonist indicated for the
treatment of chronic idiopathic constipation (CIC) in adults. Refer label for a detailed indication.
Prucalopride Tablets, 1 mg and 2 mg, have an estimated market size of US$ 100 million for twelve
months ending March 2026 according to IQVIA.
Alembic has a cumulative total of 245 ANDA approvals (225 final approvals and 20 tentative
approvals) from 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 5500 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