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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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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Prucalopride is prescribed for chronic idiopathic constipation (CIC), a condition where the cause of constipation is unknown. It helps stimulate peristalsis, natural muscle contractions in the colon, to promote more regular bowel movements. Prucalopride tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. Prucalopride tablets had annual sales of USD 186.8 mn in the United States (IQVIA MAT June 2025).

The group now has 422 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04.

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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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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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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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Bengaluru, January 20, 2025 : Zydus, a leading, discovery-based, global pharmaceutical company today announced that it has received approval from USFDA to conduct Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with Amyotrophic Lateral Sclerosis (ALS).

Under the leadership of  Principal Investigator Prof Merit Cudkowicz, MD, Director of the Sean M. Healey & AMG Centre for ALS; Chair of Neurology, Massachusetts General Hospital; Julieanne Dorn Professor of Neurology, Harvard Medical School, the Phase 2(b), randomized, double-blind, placebo-controlled, parallel-group, multicentre study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Usnoflast administered to adult subjects with ALS. This study consists of 36- week treatment phase, followed by a 16-week open label extension. This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo. The change in ALSFRS-R total score from baseline through week 36 will be measured as the primary endpoint of this trial. The key secondary endpoints will include change in SVC (Slow Vital Capacity), CSF levels of NfL (neurofilament). In addition, the biomarkers including high sensitivity C-reactive protein, (hs-CRP), interleukin (IL)-18, IL-6, IL-1β, NLRP3 and serum amyloid A (SAA), will also be evaluated.

Speaking on the development, Chairman of Zydus Lifesciences Limited, Pankaj Patel, said, “We are excited to report the approval from USFDA to initiate this randomised, double blind, placebo- controlled Phase 2(b) clinical trial in ALS patients. Zydus is committed to unlocking new frontiers in neuroscience and develop transformative breakthrough medicines.”

People living with ALS have an average survival of approximately two to five years from diagnosis, with most ALS patients dying from respiratory failure. ALS patients experience neuroinflammation and rapid neurodegeneration. Axonal neurodegeneration leads to formation of neurofilaments which first accumulate in CSF of ALS patients, and then slowly these neurofilaments enter blood circulation. Owing to rapid neurodegeneration, steady loss of the ability to move, speak, eat, eventually breathe, paralysis and death have been reported in ALS patients. ALS affects approximately 32,000 people in the U.S.A and on an average 5,000 new patients are diagnosed every year with this disease in USA as per statistics from Centre for Disease Control and Prevention (CDC). More than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom), while India has an estimated 75,000 people living with ALS.

Usnoflast (ZYIL1) is a novel, oral small molecule NLRP3 inhibitor. Usnoflast has been studied in several pre-clinical models of neuroinflammation, Parkinson’s disease, Inflammatory Bowel Disease (IBD) and Multiple Sclerosis (MS). The USFDA has granted Zydus an ‘Orphan Drug Designation’ for Usnoflast to treat patients with Cryopyrin Associated Periodic Syndrome (CAPS), a rare auto-inflammatory disease. Zydus has previously completed a Phase 2(a) randomized, double-blind, placebo controlled clinical trial in 24 ALS patients across 7 clinical trial sites in India. [ClinicalTrials.gov Identifier: NCT05981040].   It is planned to present this Phase 2(a) trial data in upcoming medical conference and publish in medical journal.

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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 inspection was successfully completed without any Form 483 observation. The inspection was conducted from 7^th October, 2024 to 8^th October, 2024.

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