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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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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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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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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The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol Tablets, 200 mg, of Novartis Pharmaceuticals Corporation. Carbamazepine Tablets USP, 200 mg are indicated for use as an anticonvulsant drug. It is also indicated in the treatment of the pain associated with true trigeminal neuralgia. Refer label for a detailed indication.

Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA.

Alembic has a cumulative total of 222 ANDA approvals (196 final approvals and 26 tentative approvals) from USFDA.

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The inspection was successfully completed without any Form 483 observation. It was conducted from 17th March 2025 to 21st March 2025.

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Financial Highlights

• Net Sales increased by 4% to Rs.1693 Crores.
• EBITDA up 1% to Rs. 271 Crores
• EBITDA Margin at 16% of Sales
• Net Profit at Rs.138 Crores

Mr. Shaunak Amin, MD, Alembic Pharmaceuticals Limited said. “In the current quarter, we faced market headwinds in the acute segment. However, other key therapies in our specialty business continued to outpace the market growth. To strengthen field force efficiency, we have enhanced Automation and AI, to upscale execution. This Transition has partly impacted quarter growth.  We are confident to show a robust growth trajectory going forward. The US Business posted significant volume growth and the Ex-US markets continued to expand steadily. API Business is still under significant pricing pressure.”

Operational Highlights

India Branded Business

India Branded Business grew 3% to Rs. 614 crores for the quarter.

Animal Health business grew 22% for the quarter with basket of strong brands driving outperformance.

Specialty therapies recorded growth of 6%.

3 launches during the quarter. New launches continue to do well along with promising future launches across key segments.

International Business

US Generics grew 10% to Rs. 521 Crores for the quarter.

2 Launches in the US market during the quarter.

Ex-US International Generics grew 10% to Rs. 299 Crores for the quarter.

7 ANDA approvals received during the quarter, 219 Cumulative ANDA approvals.

API Business

API business at Rs. 259 Crores for the quarter.

The summary of Total Revenue is as under:

                                                                           (Rs in Crores)

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Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of US$ 2.0 billion for twelve months ending September 2024 according to IQVIA.

Alembic has a cumulative total of 220 ANDA approvals (194 final approvals and 26 tentative approvals) from USFDA.

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Divalproex Sodium is an anti-epileptic drug indicated for monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures. Refer label for a detailed indication.

Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA.

Alembic has a cumulative total of 220 ANDA approvals (193 final approvals and 27 tentative approvals) from USFDA.

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The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD Extended-Release Capsules, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, of Bausch Health US, LLC. Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications. It is also indicated for the management of chronic stable angina and angina due to coronary artery spasm. Refer label for a detailed indication.

Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of US$105.3 million for twelve months ending June 2024 according to IQVIA.

Alembic has a cumulative total of 218 ANDA approvals (191 final approvals and 27 tentative approvals) from USFDA.

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