Natco Pharma – Artifex.News https://artifex.news Stay Connected. Stay Informed. Mon, 28 Sep 2026 13:31:00 +0000 en-US hourly 1 https://wordpress.org/?v=7.1.3 https://artifex.news/wp-content/uploads/2026/05/cropped-cropped-app-logo-32x32.png Natco Pharma – Artifex.News https://artifex.news 32 32 Natco Pharma to enhance total investment in eGenesis to $25 million https://artifex.news/article71519945-ece/ Mon, 28 Sep 2026 13:31:00 +0000 https://artifex.news/article71519945-ece/ Read More “Natco Pharma to enhance total investment in eGenesis to $25 million” »

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Natco positioning itself in multiplex gene-editing and genome-engineering platform
| Photo Credit: The Hindu

Natco Pharma is deepening its investment in clinical-stage biotechnology company eGenesis, increasing its planned investment through subsidiaries to $16.7 million from the earlier announced $14 million.

Under the revised investment plan, Natco Pharma’s Canadian subsidiary will invest $13.7 million, while Natco Pharma USA LLC will contribute $3 million. On completion of the transaction, Natco’s total investment in eGenesis will rise to $24.7 million.

Natco, through its Canadian subsidiary, had in 2024 invested $8 million in eGenesis, which is developing porcine solid organ donors using its multiplex gene-editing and genome-engineering platform, with the aim of addressing the shortage of human organs available for patients suffering from organ failure.

The company is currently advancing programmes focused on kidney transplantation, acute liver failure and heart transplantation. In March 2024, eGenesis achieved a milestone by announcing the world’s first transplant of a genetically modified pig kidney into a living human patient. The procedure was conducted under the U.S. Food and Drug Administration’s Expanded Access pathway.

The company subsequently performed pig kidney transplants in two additional patients, with Natco stating that the outcomes so far have been “exceptionally positive”.



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Natco Pharma Q1 net, revenue slump on lower cancer drug sales https://artifex.news/article71345441-ece/ Fri, 14 Aug 2026 12:41:00 +0000 https://artifex.news/article71345441-ece/ Read More “Natco Pharma Q1 net, revenue slump on lower cancer drug sales” »

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Drugmaker Natco Pharma’s June quarter consolidated net profit slumped 57% year-on-year (YoY) to ₹206.5 crore on the back of lower sales of generic cancer drug Lenalidomide.

The profit came on a nearly 43% YoY dip in total revenue to ₹794.4 crore, largely attributable to lower sales earnings from Lenalidomide — generic of once blockbuster cancer drug Revlimid. Growth in the base business helped partially offset the drop, the company said on Friday.

Natco Pharma shares ended 5.23% lower on the BSE at ₹902.40 apiece.

International formulations, including profit share and subsidiaries, declined to ₹477.1 crore against ₹1,120.9 crore the previous year period, showed the segmental revenue numbers of the company for the quarter.

Revenues from active pharmaceutical ingredients (API) stood at ₹66.7 crore compared to ₹52.6 crore the corresponding period of FY26); domestic pharmaceutical formulations ₹136.4 crore (₹107 crore); and crop health sciences ₹40.8 crore (₹34.7 crore) .

However, other operating and non-operating income declined marginally to ₹73.4 crore (₹75.4 crore).

Revenue of associate company Adcock Ingram Holdings, South Africa, was ₹1,582.8 crore and profit after tax ₹242.2 crore. Natco’s share of profit (based on the 35.75% holding as on June 30) stood at ₹84.3 crore. In July, Natco announced the acquisition of an additional 13.25% stake in Adcock Ingram Holding taking it stake to 49%.

₹1.5 interim dividend

Natco Board has declared an interim dividend of ₹1.5 per equity share of ₹2 each. The record date has been fixed as August 20 and the payment of the interim dividend will start from August 26.



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Natco Pharma gets USFDA nod for generic cancer drug, shares rise 4% intra-day https://artifex.news/article71246047-ece/ Mon, 20 Jul 2026 15:07:00 +0000 https://artifex.news/article71246047-ece/ Read More “Natco Pharma gets USFDA nod for generic cancer drug, shares rise 4% intra-day” »

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Hyderabad-based Indian multinational pharmaceutical and biotechnology company Natco Pharma’s shares were in the spotlight on Monday after it received tentative approval from the U.S. Food and Drug Administration (FDA) for Olaparib, 100 mg, and 150 mg, which are bioequivalent to AstraZeneca Pharmaceuticals’ referenced drug Lynparza used in the treatment of certain types of cancer.

The shares of the generic drugmaker touched more than 4% intra-day before ending the day less than 1% higher at Rs.950.55 each.

On Saturday, announcing the U.S. FDA approval, Natco Pharma said it would be manufacturing Olaparib tablets while its partner Alembic Pharmaceuticals would be distributing the product in the U.S. Olaparib tablets had estimated sales of around $1.4 billion in the U.S. for 12 months ending March 2026 as per industry sales data. The Para IV litigation, a statutory mechanism to resolve drug patent disputes, is on-going, it said.



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U.S. FDA issues seven observations to Natco Pharma’s Chennai plant https://artifex.news/article70307549-ece/ Sat, 22 Nov 2025 06:17:00 +0000 https://artifex.news/article70307549-ece/ Read More “U.S. FDA issues seven observations to Natco Pharma’s Chennai plant” »

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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 Friday (November 21, 2025).

The company believes the observations are procedural in nature and is confident to address them comprehensively, Natco Pharma said, reaffirming commitment to being cGMP compliant and supplying high-quality products.



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Natco Pharma launches generic drug for PAH in the U.S.   https://artifex.news/article69956374-ece/ Wed, 20 Aug 2025 16:46:00 +0000 https://artifex.news/article69956374-ece/ Read More “Natco Pharma launches generic drug for PAH in the U.S.  ” »

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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 sales of $10 million in the U.S. for 12 months ending June’25, the Hyderabad-based company said citing industry sales data. The drug is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in paediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability.



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Natco Pharma Q1 results: Net profit declines 28% on U.S. pricing pressure; declares interim dividend https://artifex.news/article69923689-ece/ Tue, 12 Aug 2025 10:36:00 +0000 https://artifex.news/article69923689-ece/ Read More “Natco Pharma Q1 results: Net profit declines 28% on U.S. pricing pressure; declares interim dividend” »

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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 ₹480.3 crore compared to ₹668.5 crore a year earlier amid pricing pressure in the key U.S. market and higher research and development expenditure.

The lower net profit came on a total revenue that dipped 1.42% to ₹1,390.6 crore (₹1,410.7 crore). During the quarter 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, Natco Pharma said.

₹2 interim dividend

The company has declared an interim dividend of ₹2 per equity share (of ₹2 each) for the first quarter.

Segmental revenue breakup showed formulations export declined, in the first quarter, to ₹1,126.5 crore (₹1,210.1 crore). Revenue from active pharmaceutical ingredients (API) increased to ₹52.6 crore (₹39.2 crore), while that from domestic formulations to ₹107 crore (₹102.2 crore). Crop Health Sciences revenue increased to ₹34.7 crore (₹15.6 crore).



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Natco Pharma to acquire stake in South African firm Adcock Ingram for ₹2,000 crore  https://artifex.news/article69847335-ece/ Wed, 23 Jul 2025 17:25:00 +0000 https://artifex.news/article69847335-ece/ Read More “Natco Pharma to acquire stake in South African firm Adcock Ingram for ₹2,000 crore ” »

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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 on Wednesday. Founded in 1890, AIHL has a diverse product portfolio, from generic and branded formulations, critical-care hospital products to consumer and home-care products. It operates across four segments -prescription, consumer, OTC and hospitals.

The acquisition is expected to be completed by 2025. Post-acquisition, AIHL will continue to operate as a private South African business with Bidvest holding 64.25% and Natco 35.75%, including a prior held 0.80% stake, in the company. Post-transaction, Natco will consolidate 35.75% of AIHL net profits in its financial results. AIHL clocked revenue of $536 million in the financial year June 2024 and profit after tax of $45 million.

“Adcock Ingram is a respectable pharmaceutical company with well-recognised brands and products and maintains a leading position in the South African pharmaceutical market. The proposed transaction will provide Natco Pharma with a well-established entry into the Southern African market. It will also allow us to tap into new revenue streams and expand our footprint in one of the largest and growing emerging markets, while providing a gateway to the African continent,” CEO and Vice-Chairman Rajeev Nannapaneni said.

Besides the acquisition, Natco Pharma Board also approved a proposal to incorporate a wholly owned subsidiary in South Africa with an investment of up to Rs.2,100 crore by this year to enter new geographies for growth and increased profitability. It also approved a proposal to liquidate wholly owned subsidiary Time Cap Overseas (TCOL), and directly hold the investment in step down subsidiary NatcoFarma do Brasil.

Natco shares closed 2.01% higher at ₹1,034.75 apiece on the BSE.



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Natco’s generic for PAH gets USFDA nod, marketing partner Lupin to launch product https://artifex.news/article69202074-ece/ Mon, 10 Feb 2025 09:00:52 +0000 https://artifex.news/article69202074-ece/ Read More “Natco’s generic for PAH gets USFDA nod, marketing partner Lupin to launch product” »

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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 180-day exclusivity at the time of launch. Launch details are bound by confidentiality. Lupin Pharmaceuticals, Inc., which was its partner for the abbreviated new drug application approved by the U.S. FDA, will be marketing the product in the U.S., Natco said in a release on Monday (February 10, 2025).

Bosentan TFOS, 32mg, had estimated sales of $11 million in the U.S. for 12 months ended September 2024, the company said citing industry sales data. The product is indicated for the treatment of pulmonary arterial hypertension (PAH) in those aged 3 years and above with idiopathic or congenital PAH to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability.



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U.S. FDA nod for Natco Pharma’s generic of Novartis drug  https://artifex.news/article69159149-ece/ Thu, 30 Jan 2025 11:31:49 +0000 https://artifex.news/article69159149-ece/ Read More “U.S. FDA nod for Natco Pharma’s generic of Novartis drug ” »

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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 its abbreviated new drug application (ANDA), Breckenridge Pharmaceutical Inc., plans to launch the product immediately in the U.S. market, Natco Pharma said on Thursday (January 30, 2025). The Hyderabad-based company’s shares closed less than 1% lower at ₹1,165.15 on the BSE.

Everolimus TFOS, 2mg, 3mg and 5mg, had estimated sales of $112 million in the U.S. for the 12 months ending Sep 2024, it said citing industry sales data. The product is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected, Natco Pharma said.



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Natco Pharma U.S. arm faces Fresenius complaint over diazepam injection prefilled syringe  https://artifex.news/article68078944-ece/ Thu, 18 Apr 2024 08:36:39 +0000 https://artifex.news/article68078944-ece/ Read More “Natco Pharma U.S. arm faces Fresenius complaint over diazepam injection prefilled syringe ” »

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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 relating to the marketing of Dash Pharmaceuticals diazepam injection prefilled syringe in the United States,” Natco Pharma said on April 18.

Fresenius has not yet effectuated service of the complaint which is required to commence the lawsuit. Natco Pharma intends to defend the matter accordingly, the Hyderabad-based drugmaker said in a filing. The company’s share were trading 1.97% higher at Rs.1,006.10 apeice around 1.40 p.m. on the BSE.

Natco Pharma, which had acquired Dash Pharmaceuticals LLC through a subsidiary in the U.S., had changed name of Dash Pharmaceuticals to Natco Pharma USA LLC. Fresenius specialises in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.



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