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Natco Pharma invests $14mn in biotech firm eGenesis; total investment at $22mn

admin — Tue, 25 Aug 2026 12:56:00 +0000

Generic drugmaker Natco Pharma is investing an additional $14 million in U.S.-based biotechnology company eGenesis, which is developing genetically engineered, human-compatible organs for transplantation.

The latest investment will be made through convertible promissory notes by Natco Pharma’s subsidiaries. Natco Pharma (Canada) Inc. will invest $9.5 million, while Natco Pharma South Africa Proprietary Ltd will contribute the remaining $4.5 million.

Natco Pharma had invested $8 million in eGenesis in September 2024 through preferred stock. With the latest investment, its total investment in the biotechnology firm will rise to $22 million.

eGenesis is developing genome-engineered organs aimed at addressing the global shortage of transplantable organs and improving treatment options for patients suffering from organ failure. Its proprietary EGEN (eGenesis Genome Engineering and Production) platform is designed to address cross-species molecular incompatibilities and associated viral risks.

The company is currently advancing programmes focused on kidney transplantation, acute liver failure and heart transplantation.

In March 2024, eGenesis announced the world’s first porcine kidney transplant in a living human patient. The procedure was conducted under the U.S. Food and Drug Administration’s Expanded Access pathway. The company has since reported two additional porcine kidney transplants, with outcomes described as exceptionally positive.

Natco Pharma shares closed 1.92% lower at ₹866.45 apiece on the BSE on Tuesday.

Published – August 25, 2026 06:25 pm IST

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Natco Pharma’s Vizag FDF unit gets 4 U.S. FDA observations

admin — Fri, 21 Aug 2026 15:48:00 +0000

The U.S. Food and Drug Administration (U.S. FDA) has issued a Form 483 with four observations to Natco Pharma after inspecting the generic drugmaker’s finished dosage formulations (FDF) unit in Visakhapatnam.

The U.S. FDA had conducted the inspection from August 17-21. Natco Pharma said it believes the observations are procedural in nature and is confident of addressing them comprehensively within stipulated timelines.

Published – August 21, 2026 09:18 pm IST

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Natco Pharma gets USFDA nod for generic cancer drug, shares rise 4% intra-day

admin — Mon, 20 Jul 2026 15:07:00 +0000

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.

Published – July 20, 2026 08:37 pm IST

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U.S. FDA issues warning letter to Natco over facility near Hyderabad

admin — Tue, 09 Apr 2024 08:10:59 +0000

Natco Pharma had said at the time that it was confident of addressing all the observations within the stipulated time and working with the U.S. FDA to close them at the earliest.
| Photo Credit: Reuters

The United States Food and Drug Administration (U.S. FDA) has issued a warning letter to Natco Pharma over quality concerns with the drugmaker’s Kothur manufacturing facility near Hyderabad.

The regulator’s action, which follows an inspection and issue of eight observations in October, is unlikely to impact supplies or existing revenues from the facility, Natco said in a filing. However, it added that the move may result in delay or withholding of pending product approvals from the site.

Without detailing the contents of the April 8 warning letter, the company said it would respond within the stipulated timelines and work closely with the FDA to address the concerns in a timely manner so as to ensure sustained compliance. Natco said it also remains committed to being compliant with current good manufacturing practices (CGMP) and ensuring it supplies high-quality products to its customers and patients globally.

In October, the company had said its Kothur manufacturing facility had undergone a routine CGMP inspection from October 9-18 at the end of which the U.S. FDA has issued eight observations. Natco Pharma had said at the time that it was confident of addressing all the observations within the stipulated time and working with the U.S. FDA to close them at the earliest.

The plant produces formulations and makes oral and solid dosages, including dry powder, cytotoxic and noncytotoxic orals and cytotoxic injectables, according to the company’s website.

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