NSEPress Release3d ago · 18 Jul 2026, 08:35 pm
Press Release
Alembic Pharmaceuticals Limited · APLLTD
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Alembic Pharmaceuticals Limited's partner NATCO Pharma Limited receives USFDA tentative approval for Olaparib Tablets, 100 mg and 150 mg. This is the 244th ANDA approval for Alembic, with 224 final approvals and 20 tentative approvals.
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Full Announcement
Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated July 18, 2026, titled "Alembic Pharmaceuticals Limited's Partner NATCO Pharma Limited receives USFDA Tentative Approval for Olaparib Tablets, 100 mg and 150 mg".
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Date: 18th 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’s Partner NATCO Pharma Limited receives USFDA
Tentative Approval for Olaparib Tablets, 100 mg and 150 mg.
With reference to the captioned subject, this is to inform the exchange that the Company’s
Partner NATCO Pharma Limited has received US Food & Drug Administration (USFDA) Tentative
Approval for Olaparib Tablets, 100 mg and 150 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
18th July, 2026 Vadodara, India
Alembic Pharmaceuticals Limited’s Partner NATCO Pharma Limited receives USFDA Tentative
Approval for Olaparib Tablets, 100 mg and 150 mg
Alembic Pharmaceuticals Limited (Alembic) today announced that its Partner NATCO Pharma
Limited (NATCO) has received tentative approval from the United States Food and Drug
Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olaparib Tablets, 100
mg and 150 mg. The approved ANDA is therapeutically equivalent to the reference listed drug
product (RLD), Lynparza Tablets, 100 mg and 150 mg, of AstraZeneca Pharmaceuticals LP
(AstraZeneca) for the indication in the approved labelling. Alembic will distribute the product in
the U.S., and its partner NATCO will manufacture Olaparib Tablets, 100 mg and 150 mg.
The Para IV litigation is on-going. Olaparib Tablets, 100 mg and 150 mg, have an estimated
market size of approximately USD 1.4 billion in the U.S. for twelve months ending March 2026,
according to IQVIA.
Alembic has a cumulative total of 244 ANDA approvals (224 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