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Alembic Pharmaceuticals Limited receives USFDA Final Approval for Macitentan Tablets

Newsmantra — Wed, 20 Aug 2025 10:36:42 +0000

19^th August 2025, Bengaluru: 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) Macitentan Tablets, 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc. (Actelion).

Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. Refer label for a detailed indication.

Macitentan Tablets, 10 mg, have an estimated market size of US$ 1,180 million for twelve months ending June 2025 according to IQVIA.

Alembic has a cumulative total of 224 ANDA approvals (203 final approvals and 21 tentative approvals) from USFDA.

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Alembic Pharmaceuticals Limited receives USFDA Final Approval for Tretinoin Cream

Newsmantra — Mon, 18 Aug 2025 12:09:07 +0000

18^th August 2025, Bengaluru: 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) Tretinoin Cream USP, 0.025%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. Refer label for a detailed indication.

Tretinoin cream USP, 0.025%, has an estimated market size of US$ 94 million for twelve months ending June 2025 according to IQVIA.

Alembic has a cumulative total of 224 ANDA approvals (202 final approvals and 22 tentative approvals).

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Alembic Pharmaceuticals Limited announces USFDA Final Approval for Carbamazepine Extended-Release Tablets.

Newsmantra — Mon, 28 Jul 2025 12:42:10 +0000

28 July, 2025, Bengaluru: 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) Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol-XR Extended-Release Tablets, 100 mg, 200 mg, and 400 mg, of Novartis Pharmaceuticals Corporation.

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug and also for the treatment of the pain associated with true trigeminal neuralgia. Refer label for a detailed indication.

Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg, have an estimated market size of US$ 71 million for twelve months ending March 2025 according to IQVIA.

Alembic has a cumulative total of 225 ANDA approvals (202 final approvals and 23 tentative approvals) from USFDA.

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Alembic Pharmaceuticals Limited announces USFDA Final Approval for Amlodipine and Atorvastatin Tablets

Newsmantra — Fri, 23 May 2025 11:09:30 +0000

23^rd May, 2025, Bengaluru: 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) Amlodipine and Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Caduet Tablets, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, of Pharmacia and Upjohn Co. LLC.

Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Refer label for a detailed indication.

Alembic has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from USFDA.

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Alembic Pharmaceuticals Limited announces USFDA Final Approval for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg

Newsmantra — Thu, 15 May 2025 12:14:19 +0000

15 May, 2025 Bengaluru: 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) Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen).

Rivaroxaban tablets, 2.5mg, are indicated: i) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD), ii) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD. Refer label for a detailed indication.

According to IQVIA, Rivaroxaban Tablets USP, 2.5 mg, has an estimated market size of US$ 445 million for twelve months ending March 2025 and Alembic will be launching this strength in Q1FY26.

The estimated market size for remaining strengths of Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg, is US$ 8,052 million for twelve months ending March 2025 according to IQVIA.

Alembic has a cumulative total of 222 ANDA approvals (198 final approvals and 24 tentative approvals) from USFDA.

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Alembic Pharmaceuticals Limited announces USFDA Final Approval for Ivabradine Tablets, 5 mg and 7.5 mg

Newsmantra — Tue, 12 Nov 2024 12:15:37 +0000

12^th November 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg and 7.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen).

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. Refer label for a detailed indication.

Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 145.3 million for twelve months ending September 2024 according to IQVIA.

Alembic has a cumulative total of 218 ANDA approvals (192 final approvals and 26 tentative approvals) from USFDA.

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Alembic honoured with Guinness World Record for Hypertension Awareness Milestone

Newsmantra — Tue, 12 Nov 2024 11:35:23 +0000

~Over 15,000 Healthcare professionals take a pledge towards better hypertension management~

12 November 2024, Bengaluru: Alembic Pharmaceuticals Limited, a leading pharmaceutical company, today announced that its Summit division has been recognized by Guinness World Records for collecting the most number of pledges for a hypertension campaign. This recognition underscores the company’s commitment to addressing public health issues in India.

Hypertension, or high blood pressure, affects 28.1% of India’s adult population, yet only a fraction are diagnosed and treated. Realizing the need for urgent action, Alembic’s Summit division took a bold step to close this gap. On the occasion of World Hypertension Day on 17^th May 2024, the team launched a week-long campaign that reached out to 15,568 Health Care Professionals (HCPs) across India, from May 13th to May 19^th 2024. Through this initiative, HCPs were encouraged to take an online pledge to promote better hypertension management and patient education, aiming for early diagnosis and improved treatment outcomes.

Commenting on this occasion, Shaunak Amin, Managing Director, Alembic Pharmaceutical said, “Hypertension is a critical health crisis in India, impacting millions who often remain undiagnosed and untreated. Our teams focused on raising awareness and educating healthcare professionals to address this urgent issue. We are grateful to Guinness World Records for recognizing our efforts, and this acknowledgement reflects our commitment to making a meaningful impact on society. I extend my heartfelt congratulations to the entire team for their dedication and achievement in this remarkable initiative.”

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Alembic Pharmaceuticals announces early participation in the Prime Minister’s Internship Scheme

Newsmantra — Mon, 07 Oct 2024 12:32:52 +0000

7 October, 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced its early participation in the Prime Minister’s Internship Scheme, a visionary initiative aimed at offering internship opportunities to one crore young Indians in the country’s top 500 companies over the next five years.

Amongst the first in the country to partake in this scheme, Alembic has already listed 125 internship positions, spanning key technical areas within the company.

Alembic is excited to it join this national initiative to nurture young talent and provide hands-on experience. The Prime Minister’s Internship Scheme aligns with Alembic HR’s commitment to skills development and building a future-ready workforce, and compliments its FreshWave initiative of hiring entry level talent from campus (Alembic this year hired more than 300 entry-level professionals as part of FreshWave.).

The Prime Minister’s Internship Scheme benefits both interns, who gain practical industry exposure, and the company, as it engages with and mentors the next generation of potential talent.

The internships offered by Alembic encompass multiple functions including Production, Quality Assurance, Quality Control, Engineering, etc.

Eligible candidates will be able to log into the governmental portal http://www.pminternship.mca.gov.in to register for the positions from October 12, 2024 onwards.

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Alembic Pharmaceuticals announces USFDA Final Approval for Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg.

Newsmantra — Fri, 04 Oct 2024 11:48:24 +0000

3^rd October 2024, Bengaluru: 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) Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK).

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. Also indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. Refer label for a detailed indication.

Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg have an estimated market size of US$ 163 million for twelve months ending June 2024 according to IQVIA.

Alembic has a cumulative total of 216 ANDA approvals (188 final approvals and 28 tentative approvals) from USFDA.

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Alembic Pharmaceuticals Limited received an Establishment Inspection Report (EIR) for its Oral Solid Formulation Facility(F-1) at Panelav.

Newsmantra — Mon, 30 Sep 2024 12:48:07 +0000

30 September 2024, Bengaluru: Alembic Pharmaceuticals Limited is pleased to announce that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Oral Solid Formulation Facility (F-I) located in Panelav.

The inspection, which took place from 17th July 2024 to 26th July 2024, has been successfully concluded. With this, all of the company’s USFDA-approved facilities now have EIRs in place.

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