According to reports from CNBC TV18 and Business Standard, Natco Pharma announced that a US Food and Drug Administration (FDA) inspection at its Finished Dosage Formulations (FDF) manufacturing unit in Visakhapatnam concluded with four observations. The inspection was conducted from August 17 to August 21, 2026, at the company's FDF manufacturing facility located in Parawada, Visakhapatnam. At the conclusion of the inspection, the company was issued a Form 483 with four observations, as reported in a regulatory filing. The company stated it believes the observations are procedural in nature and is confident of addressing them comprehensively within the stipulated timelines. A Form 483 lists observations made by USFDA inspectors during an inspection and does not represent a final FDA determination on the facility's compliance with good manufacturing practices.
On Tuesday, August 25, Natco Pharma announced an additional $14 million investment in US-based biotechnology company eGenesis Inc, bringing its total investment to $22 million. The fresh investment is being made through Natco Pharma's wholly-owned subsidiaries - NATCO Pharma (Canada) Inc. will invest $9.5 million, while NATCO Pharma South Africa Proprietary Limited will invest $4.5 million. The investment is being made via convertible promissory notes carrying an 8% annual compounded interest rate, with principal amounts of $9.5 million and $4.5 million respectively. The investment is aimed at supporting new-age therapeutic programmes addressing critical unmet medical needs, and the company stated the investment does not constitute a related-party transaction. The latest investment follows Natco's $8 million investment in eGenesis in 2024 through preferred stock. The transaction is expected to be completed by September 30, with no additional shares in eGenesis being acquired at the time of completion.
According to Business Standard, eGenesis is pioneering a genome engineering-based approach in the development of safe and effective transplantable organs to end the global organ shortage and transform the treatment of organ failure. The eGenesis Genome Engineering and Production (EGEN) platform is the only technology of its kind to comprehensively address cross-species molecular incompatibilities and viral risk via genetic engineering to improve the lives of patients in need of a transplant. eGenesis is advancing development programmes for kidney transplant, acute liver failure, and heart transplant. In March 2024, eGenesis announced the world's first porcine kidney transplant in a living patient, which was authorised by the USFDA under the Expanded Access pathway. This was followed by porcine kidney transplants in two additional patients, with outcomes described as exceptionally positive.
Shares of Natco Pharma were trading at ₹871 in afternoon trade on Tuesday, down 1.5% following the announcement. The stock has declined about 1.9% so far in 2026, compared with a 7.5% fall in the Nifty 50. The company has a market capitalisation of around ₹15,600 crore. The stock has declined over 11% in the last six months and about 2% since the beginning of this year. The company's shares ended at ₹882.50, up by 0.54%, on the BSE on Friday, according to Business Standard. Natco Pharma develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharma ingredients and crop protection products.
According to reports from CNBC TV18 and Business Standard, Natco Pharma reported a 57% year-on-year decline in profit to ₹206.5 crore in the first quarter, compared with ₹480.7 crore in the year-ago period. The company's revenue declined 44.68% to ₹735.20 crore from ₹1,328.9 crore in the June quarter last year. The company's earnings before interest, taxes, depreciation and amortisation (EBITDA) declined 67.3% in the first quarter to ₹186.5 crore from ₹571 crore in the prior fiscal. Its margins also contracted sharply to 25.4% from 43% in the year-ago period.
