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Alembic Pharmaceuticals and Amlan International launch MinerTox-Z and MinerTox-A

Newsmantra — Tue, 07 Oct 2025 12:17:48 +0000

~These products strengthen poultry immunity, improve productivity, and support sustainable farming practices~

07 October, 2025: Bengaluru: Alembic Pharmaceuticals Ltd., through a strategic agreement with Amlan International, today announced the India launch of MinerTox-Z and MinerTox-A, feed additive solutions developed to protect poultry against toxins and enhance farm productivity.

The introduction of these products represents an important step in addressing one of the poultry industry’s most pressing challenges—losses caused by toxins. By combining Alembic’s strong presence in India with Amlan’s globally proven technology, this launch ensures that farmers gain access to advanced solutions designed specifically to safeguard flock health and profitability.

MinerTox-Z delivers broad-spectrum protection through rapid binding efficiency against both fungal (mycotoxins) and bacterial toxins, while MinerTox-A is an advanced mycotoxin binder engineered to provide long-lasting results. Together, they go beyond traditional toxin binding by strengthening immunity, protecting bird performance, and reducing hidden economic losses.

Highlighting the importance of this launch, Mr. P. Karunanithi, Executive Vice President (Cluster Head) of the Animal Health Division, Alembic Pharmaceuticals Ltd., said, “MinerTox-Z and MinerTox-A are more than just toxin binders; they represent a science-driven approach to empowering Indian poultry farmers. By helping protect birds from multiple threats and improving their overall resilience, these solutions will enable an immunity boost & ensure consistent productivity.”

This launch reinforces the joint commitment of Alembic Pharmaceuticals and Amlan International to advancing poultry health with modern, sustainable, and performance-focused innovations.

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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 Doxorubicin Hydrochloride Liposome Injection

Newsmantra — Mon, 30 Jun 2025 11:33:09 +0000

30^th June, 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) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation.

Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi’s Sarcoma, and Multiple Myeloma. Refer label for a detailed indication.

Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) Single-Dose Vials have an estimated market size of US$ 29 million for twelve months ending March 2025 according to IQVIA.

Alembic has a cumulative total of 224 ANDA approvals (201 final approvals and 23 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 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 announces USFDA Tentative Approval for Ivosidenib Tablets 250 mg

Newsmantra — Fri, 05 Jul 2024 06:00:57 +0000

4July 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivosidenib Tablets, 250 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tibsovo Tablets, 250 mg, of Servier Pharmaceuticals LLC (Servier).

Ivosidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: (a) Newly Diagnosed Acute Myeloid Leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy (b) Adult patients with Relapsed or refractory AML (c) Adult patients with Locally Advanced or Metastatic Cholangiocarcinoma who have been previously treated.

Ivosidenib Tablets, 250 mg have an estimated market size of US$ 114 million for twelve months ending March 2024 according to IQVIA.

Alembic has a cumulative total of 207 ANDA approvals (179 final approvals and 28 tentative approvals) from USFDA.

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