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Pharmaceuticals, Small Cap

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brilinta Tablets, 60 mg and 90 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca).

Ticagrelor tablets are indicated for: i) to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. ii) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events, and iii) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score <5) or high-risk transient ischemic attack (TIA). 

For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification.

Ticagrelor Tablets, 90 mg have an estimated market size of US$ 1,062 million for twelve months ending March 2025 according to IQVIA. Ticagrelor Tablets, 60 mg have an estimated market size of US$ 242 million for twelve months ending March 2025 according to IQVIA.

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The company announced in an exchange filing that the EIR pertains to an inspection conducted by the USFDA at its Oncology Formulation Facility (F-2), which includes both injectable and oral solid formulations. The inspection was carried out from 7 October 2024 to 8 October 2024.

In an earlier filing dated 9th October 2024, the company informed that it had successfully completed the USFDA inspection for its Oncology Formulation Facility (F-2) located at Panelav. The inspection was successfully completed without any Form 483 observation.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company that 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.

The company?s consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY).

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Alembic Pharmaceuticals has commissioned a new manufacturing facility located at Pithampur, Dist: Dhar, Madhya Pradesh-454774 effective today, for manufacturing of formulations.

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The company announced in an exchange filing that the EIR pertains to an inspection conducted by the USFDA at its Oncology Formulation Facility (F-2), which includes both injectable and oral solid formulations. The inspection was carried out from 7 October 2024 to 8 October 2024.

In an earlier filing dated 9th October 2024, the company informed that it had successfully completed the USFDA inspection for its Oncology Formulation Facility (F-2) located at Panelav. The inspection was successfully completed without any Form 483 observation.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company that 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.

The company?s consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY).

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Alembic Pharmaceuticals has commissioned a new manufacturing facility located at Pithampur, Dist: Dhar, Madhya Pradesh-454774 effective today, for manufacturing of formulations.

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Alembic Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 6 May 2025.

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Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brilinta Tablets, 60 mg and 90 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca).

Ticagrelor tablets are indicated for: i) to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. ii) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events, and iii) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score <5) or high-risk transient ischemic attack (TIA). 

For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification.

Ticagrelor Tablets, 90 mg have an estimated market size of US$ 1,062 million for twelve months ending March 2025 according to IQVIA. Ticagrelor Tablets, 60 mg have an estimated market size of US$ 242 million for twelve months ending March 2025 according to IQVIA.

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The company announced in an exchange filing that the EIR pertains to an inspection conducted by the USFDA at its Oncology Formulation Facility (F-2), which includes both injectable and oral solid formulations. The inspection was carried out from 7 October 2024 to 8 October 2024.

In an earlier filing dated 9th October 2024, the company informed that it had successfully completed the USFDA inspection for its Oncology Formulation Facility (F-2) located at Panelav. The inspection was successfully completed without any Form 483 observation.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company that 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.

The company?s consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY).

Powered by Capital Market - Live News

Alembic Pharmaceuticals has commissioned a new manufacturing facility located at Pithampur, Dist: Dhar, Madhya Pradesh-454774 effective today, for manufacturing of formulations.

Powered by Capital Market - Live News

The company announced in an exchange filing that the EIR pertains to an inspection conducted by the USFDA at its Oncology Formulation Facility (F-2), which includes both injectable and oral solid formulations. The inspection was carried out from 7 October 2024 to 8 October 2024.

In an earlier filing dated 9th October 2024, the company informed that it had successfully completed the USFDA inspection for its Oncology Formulation Facility (F-2) located at Panelav. The inspection was successfully completed without any Form 483 observation.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company that 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.

The company?s consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY).

Powered by Capital Market - Live News

Alembic Pharmaceuticals has commissioned a new manufacturing facility located at Pithampur, Dist: Dhar, Madhya Pradesh-454774 effective today, for manufacturing of formulations.

Powered by Capital Market - Live News

Alembic Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 6 May 2025.

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