Lupin receives USFDA approval for Rivaroxaban Tablets
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Zydus Lifesciences receives four observations from USFDA following inspection at Himachal Pradesh facility
Zydus Lifesciences announced that its formulation manufacturing facility located in Baddi, Himachal Pradesh, has received four observations from the United States Food and Drug Administration (USFDA). According to an exchange filing, the company stated that the USFDA concluded a surveillance inspection at the Baddi facility, which was conducted from 4 August to 13 August 2025. The inspection ended with four observations. The company clarified that none of the observations were related to data integrity. Zydus added that it will work closely with the USFDA to address and resolve the observations expeditiously. In a separate filing, the company also informed that the USFDA conducted a Pre-Approval Inspection (PAI) at its formulation manufacturing facility located in SEZ II, Ahmedabad. The inspection, which covered three products and general current Good Manufacturing Practices (cGMP), was conducted from 11 August to 13 August 2025. This inspection concluded with no observations, indicating a clean outcome. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The companys consolidated net profit shed 1% to Rs 1,170.90 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24. The counter added 1.35% to end at Rs 1,002.40 on the BSE.
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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.
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3 days ago
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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).
