Latest news with #XareltoTablets
Business Standard
4 days ago
- Business
- Business Standard
Indoco Remedies gains on receiving USFDA nod for Rivaroxaban tablets
Indoco Remedies rose 1.56% to Rs 296.15 after the company announced it had received final approval from the USFDA for its ANDA for Rivaroxaban tablets USP. The approval covers strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg. The approved tablets are bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Xarelto Tablets, manufactured by Janssen Pharmaceuticals, Inc. The product will be manufactured at Indocos facility in Verna Industrial Area, Goa (L-14, Verna, Goa 403722). Rivaroxaban is an oral anticoagulant used for the treatment and prevention of venous thromboembolism (VTE) a serious condition involving blood clots in the veins, which can lead to complications such as pulmonary embolism. Commenting on the development, Aditi Panandikar, managing director of Indoco Remedies, said, Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US. Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs). The company had reported a consolidated net loss of Rs 40.39 crore in the quarter ended March 2025 as against net profit of Rs 22.70 crore during the previous quarter ended March 2024. Sales declined by 12.57% to Rs 383.89 crore in Q4 FY25 over Q4 FY24.
Business Standard
4 days ago
- Business
- Business Standard
Indoco Remedies receives USFDA approval for Rivaroxaban Tablets
Indoco Remedies announced final approval of the Company's Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20 mg, to market a generic equivalent to the reference listed drug (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen), from USFDA. Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20 mg are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen). Rivaroxaban Tablets USP, will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa 403722 in India. Rivaroxaban is used for the treatment of venous thromboembolism (VTE).
Business Standard
15-05-2025
- Business
- Business Standard
Alembic Pharma rises on USFDA approval for Rivaroxaban Tablets
Alembic Pharmaceuticals advanced 1.10% to Rs 918.15 after the company received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Rivaroxaban Tablets. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen). Rivaroxaban tablets, 2.5mg, are indicated to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) and 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. According to IQVIA, Rivaroxaban Tablets USP, 2.5 mg, has an estimated market size of $445 million for twelve months ending March 2025 and the company 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 $8,052 million for twelve months ending March 2025 according to IQVIA. The company has a cumulative total of 222 ANDA approvals (198 final approvals and 24 tentative approvals) from USFDA. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24.
Business Standard
15-05-2025
- Business
- Business Standard
Lupin receives USFDA approval for Rivaroxaban Tablets
Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg. Rivaroxaban Tablets are bioequivalent to Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals. This product will be manufactured at Lupin's Aurangabad facility in India.
Business Standard
15-05-2025
- Business
- Business Standard
Alembic Pharmaceuticals receives USFDA approval for Rivaroxaban 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) Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen). 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.
