Tag: Natco Pharma

U.S. FDA issues seven observations to Natco Pharma’s Chennai plant

November 22, 2025 admin

Natco Pharma’s active pharmaceutical ingredients unit in Chennai has received seven observations from the U.S. Food and Drug Administration. The U.S. FDA had conducted an inspection at the API manufacturing plant in Manali, Chennai, from November 17-21. On conclusion, of the inspection, the company received seven observations in the Form-483, the generic drugmaker said on…

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Natco Pharma launches generic drug for PAH in the U.S.

August 20, 2025 admin

Natco Pharma has launched Bosentan tablets for oral suspension, 32mg, a generic version of Actelion Pharmaceuticals’ Tracleer in the U.S. It holds the first-to-file status for this product and will have 180-day generic drug exclusivity, Natco said on Wednesday (August 20, 2025. Lupin is its marketing partner for the product. Bosentan TFOS, 32mg, had estimated…

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Natco Pharma Q1 results: Net profit declines 28% on U.S. pricing pressure; declares interim dividend

August 12, 2025 admin

According to Natco Pharma, during the April-June quarter this year, the business faced pricing pressure in the U.S. product portfolio and the company incurred increased R&D expenses on account of high value projects. File | Photo Credit: Reuters Generic drugmaker Natco Pharma reported consolidated net profit for the June quarter declined more than 28% to…

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Natco Pharma to acquire stake in South African firm Adcock Ingram for ₹2,000 crore

July 23, 2025 admin

Natco Pharma has made an offer to acquire nearly 36% stake in South African pharmaceutical company Adcock Ingram Holdings (AIHL) for $226 million (around ₹2,000 crore). The proposal to acquire the stake from minority shareholders in an all cash deal is a strategic investment aimed at to expanding geographic footprint in South Africa, Natco said…

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Natco’s generic for PAH gets USFDA nod, marketing partner Lupin to launch product

February 10, 2025 admin

Image for representation. Natco Pharma has received U.S. Food and Drug Administration final approval for Bosentan tablets for oral suspension, 32mg, its generic version of Actelion Pharmaceuticals US Inc.’s pulmonary arterial hypertension drug Tracleer. The Hyderabad-based generic drugmaker said it believes it has the sole first-to-file status for the product and consequently eligible for a…

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U.S. FDA nod for Natco Pharma’s generic of Novartis drug

January 30, 2025 admin

Hyderabad-based company Natco Pharma’s shares closed less than 1% lower at ₹1,165.15 on the BSE on January 30, 2025. File Natco Pharma has received U.S. Food and Drug Administration (U.S. FDA) approval for Everolimus tablets for oral suspension, 2mg, 3mg and 5mg, a generic version of Novartis Pharmaceutical Corporation’s Afinitor Disperz. Marketing partner for…

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Natco Pharma U.S. arm faces Fresenius complaint over diazepam injection prefilled syringe

April 18, 2024 admin

Natco Pharma subsidiary in the U.S. is facing a complaint from global healthcare company Fresenius over marketing of Diazepam injection prefilled syringe in the country. “Fresenius Kabi USA, LLC and Fresenius Kabi Deutschland GmbH have filed a complaint against Natco Pharma USA LLC [formerly known as Dash Pharmaceuticals LLC] in the District Court of Delaware…

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