NSEPress Release3d ago · 18 Jul 2026, 08:35 pm

Press Release

Alembic Pharmaceuticals Limited · APLLTD

✦ AI Summary▲ PositiveOrder Win

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.

Analysis Scores

Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk5/10
Liquidity Impact9/10
Market Sentiment8/10

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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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APLLTD_18072026203448_Intimation_to_SE_Press_Release_Natco.pdf

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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