Latest news with #ANDA
Time of India
3 days ago
- Business
- Time of India
Alembic Pharmaceuticals gets USFDA nod for generic Carbamazepine tablets
Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic version of Carbamazepine extended-release tablets indicated for treatment of seizures, and relieving nerve pain. The approval by the US Food & Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) of Carbamazepine extended-release tablets of strengths 100 mg, 200 mg, and 400 mg, it said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product Tegretol-XR extended-release tablets in the same strengths, of Novartis Pharmaceuticals Corporation, it added. Alembic said 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. Citing IQVIA data for the 12 months ended March 2025, the company said Carbamazepine extended-release tablets of 100 mg, 200 mg, and 400 mg, have an estimated market size of USD 71 million.
News18
3 days ago
- Business
- News18
Alembic Pharmaceuticals gets USFDA nod for generic Carbamazepine tablets
Agency: PTI Last Updated: New Delhi, Jul 28 (PTI) Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic version of Carbamazepine extended-release tablets indicated for treatment of seizures, and relieving nerve pain. The approval by the US Food & Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) of Carbamazepine extended-release tablets of strengths 100 mg, 200 mg, and 400 mg, it said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product Tegretol-XR extended-release tablets in the same strengths, of Novartis Pharmaceuticals Corporation, it added. Alembic said 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. Citing IQVIA data for the 12 months ended March 2025, the company said Carbamazepine extended-release tablets of 100 mg, 200 mg, and 400 mg, have an estimated market size of USD 71 million. PTI RKL ANU ANU Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
Business Standard
5 days ago
- Business
- Business Standard
Alembic Pharmaceuticals receives USFDA approval for Carbamazepine Extended-Release Tablets
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) 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.
Business Upturn
5 days ago
- Business
- Business Upturn
Alembic Pharma gets USFDA nod for Carbamazepine Extended-Release Tablets
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbamazepine Extended-Release Tablets USP in strengths of 100 mg, 200 mg, and 400 mg. These tablets are the generic version of Tegretol-XR, a widely used anticonvulsant drug developed by Novartis Pharmaceuticals. Alembic's version is therapeutically equivalent to the original, meaning it meets the same standards for quality, strength, and effectiveness. Carbamazepine Extended-Release Tablets are primarily used to treat seizure disorders and are also prescribed for trigeminal neuralgia, a chronic pain condition affecting the facial nerves. According to IQVIA data, the US market for this drug was valued at approximately $71 million for the 12-month period ending March 2025. With this approval, Alembic now has a total of 225 ANDA approvals from the USFDA, which includes 202 final approvals and 23 tentative approvals. About Alembic Pharmaceuticals Founded in 1907 and headquartered in India, Alembic Pharmaceuticals is a vertically integrated pharmaceutical company known for its strong focus on research and development. It manufactures and markets generic drugs across global markets, with several of its facilities approved by top regulatory bodies including the USFDA. In India, Alembic is a leader in branded generics, with a product portfolio promoted by a field force of over 5,500 professionals. Its products are widely recognized and trusted by healthcare professionals and patients alike. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
&w=3840&q=100)
Business Standard
7 days ago
- Business
- Business Standard
Q1 miss for Dr Reddy's, but analysts remain hopeful for future prospects
Despite missing Q1 expectations, Dr Reddy's continues to see growth in key markets like Europe and India, while managing costs to offset challenges in the US Devangshu Datta Mumbai Listen to This Article In the April-June quarter (Q1) of FY26, Dr Reddy's (DRL) US sales fell 4 per cent quarter-on-quarter (QoQ) to $400 million due to erosion in gRevlimid earnings caused by pricing pressure. On a positive note, DRL posted double-digit growth in most ex-US markets, but overall revenue disappointed. The absence of meaningful abbreviated new drug application (ANDA) approvals for DRL, as well as impending tariffs (since it has no US-based formulations facility), remain concerns. DRL's Q1 FY26 revenue grew 11 per cent year-on-year (YoY) to Rs 8,570 crore, and Europe sales jumped 1.4x YoY to Rs 1,270 crore (15 per cent
