Natco Pharma Share News - Latest Updates, Live News & More

Latest news about Natco Pharma

Supreme Court Greenlights Natco Pharma's RISDIPLAM Drug Launch, Overruling Roche's Opposition Oct 17, 2025

The Supreme Court has granted approval to Natco Pharma to introduce the RISDIPLAM drug, rejecting Roche's request to prevent the launch. RISDIPLAM is used to treat spinal muscular atrophy (SMA). This decision could increase competition in the pharmaceutical market and potentially improve accessibility for SMA patients in India.

Roche Challenges High Court Ruling on Natco Pharma's Risdiplam Release Oct 14, 2025

Natco Pharma Secures Overwhelming Shareholder Approval for Adcock Ingram Acquisition Oct 10, 2025

Natco Pharma Set to Launch Risdiplam at Rs 15,900 After Landmark Delhi High Court Ruling Oct 09, 2025

NATCO Pharma's Senior Vice President Dr. Santhan Gopalakrishnan Vaidyanathan to Superannuate in 2025 Sep 30, 2025

More news about Natco Pharma

25Sept 25

Natco Pharma Board Approves Assessment for Agro Business Spin-off

Natco Pharma's board has given in-principle approval to evaluate the demerger of its agro business into a separate entity. The move aims to unlock value, enhance focus, and provide operational flexibility for both pharmaceutical and agro segments. Natco may retain a minority stake in the new agro entity to support it with R&D, patents, and transitional services. The management will conduct a detailed evaluation, suggest optimal structures, and present findings to the Audit Committee and Board. The company will make appropriate disclosures once the final structure is approved.

18Sept 25

Natco Pharma's Hyderabad Facility Receives 'Voluntary Action Indicated' Classification from USFDA

Natco Pharma announced that its pharmaceutical division in Kothur, Hyderabad, has received an Establishment Inspection Report (EIR) from the U.S. FDA. The facility has been classified as 'Voluntary Action Indicated' (VAI), indicating that while some issues were found during inspection, they are not significant enough to warrant regulatory action. This classification allows Natco to continue operations at the site while addressing any concerns raised by the FDA.

16Sept 25

Natco Pharma Poised to Benefit as Indian Patent Office Revokes Novartis Heart Drug Patent

The Indian Patent Office has revoked the patent for Novartis' heart drug Vymada, allowing generic drug manufacturers to produce and sell alternative versions. This decision could benefit companies like Natco Pharma, potentially leading to increased competition and more affordable options for patients. The move highlights India's efforts to balance intellectual property rights with public health concerns. Separately, Natco Pharma disclosed receiving information from Smt. Satya Vani Nannapaneni under SEBI regulations, though specific details were not provided.

21Aug 25

Natco Pharma Challenges Novo Nordisk in Wegovy Patent Lawsuit

Natco Pharma has filed a lawsuit against Novo Nordisk, challenging patent claims for the weight loss drug Wegovy. This legal action could potentially allow for the development of generic versions of Wegovy. Simultaneously, Natco Pharma has launched Bosentan tablets, a generic version of Tracleer®, in the U.S. market through its partner Lupin Limited. The Bosentan tablets, used for treating pulmonary arterial hypertension in pediatric patients, come with a 180-day generic drug exclusivity. The estimated U.S. sales for this product are approximately $10 million for the 12 months ending June 2025.

20Aug 25

Natco Pharma Launches Bosentan Tablets in U.S. with 180-Day Exclusivity

Natco Pharma has launched Bosentan tablets for oral suspension (32mg) in the U.S. market, a generic version of Tracleer®. The company secured 180-day exclusive marketing rights for this product, which is indicated for treating pulmonary arterial hypertension in pediatric patients. Lupin Limited is Natco's marketing partner for this product in the U.S. The drug had estimated sales of $10.00 million in the U.S. for the 12 months ending June 2025.

19Aug 25

NATCO Pharma Reports Flat Revenue in Q1, Warns of Potential Revenue Decline

Natco Pharma's Q1 consolidated revenue slightly decreased to INR 1,390.60 crores from INR 1,410.70 crores year-over-year. Despite this, the company maintained strong profitability with an EBITDA of INR 632.70 crores and a net profit of INR 480.30 crores. The company declared an interim dividend of INR 2.00 per equity share. Facing pricing pressure in the U.S. market, particularly for Revlimid, Natco anticipates a 20% revenue drop and a 30% profit decline. To mitigate risks, the company has acquired a 35.75% stake in South Africa's Adcock Ingram, plans to file new products in the U.S., and is investing in R&D for cancer products, peptides, and oligopeptide-type products. The company is awaiting resolution for its Kothur facility inspection and is preparing for potential launches of Semaglutide, Risdiplam, and Pomalidomide, subject to regulatory clearances.

12Aug 25

Natco Pharma Reports Mixed Q1 Results Amid Pricing Pressures

Natco Pharma's Q1 results show a slight revenue decline of 1.4% to ₹1,390.60 crore, with net profit down 28.2% to ₹480.30 crore due to U.S. pricing pressures and increased R&D expenses. EBITDA margin remained strong at 45.5%. Segment-wise, Crop Health Sciences grew 122.4%, API 34.2%, while Formulations Export declined 6.9%. The company declared an interim dividend of ₹2 per share and plans to increase its Authorized Capital to ₹45 crore.

30Jul 25

NATCO Pharma Appoints T.C. Mallikarjun as Vice President - QC at Kothur Division

Natco Pharma has appointed Mr. T.C. Mallikarjun as Vice President – Quality Control (QC) at their Pharma Division in Kothur, effective July 30, 2025. Mallikarjun, previously Senior General Manager - Head QC at Aurobindo Pharma Limited, brings extensive experience in handling regulatory inspections from agencies like USFDA, MHRA, TGA, and ANVISA. He will oversee quality control operations at the Kothur facility, leveraging his expertise in managing new products and exhibit validations. This appointment aligns with Natco Pharma's efforts to enhance leadership and maintain high quality standards in pharmaceutical operations.

24Jul 25

Natco Pharma's API Unit Receives FDA Inspection Report with Voluntary Action Indicated

Natco Pharma's API manufacturing unit in Mekaguda, Hyderabad, has received an Establishment Inspection Report (EIR) from the U.S. FDA following an inspection from June 9th to 13th. The inspection resulted in one observation classified as 'Voluntary Action Indicated' (VAI). The company received the EIR on July 24th, indicating the FDA's acceptance of their response to the observation. This outcome is generally positive, suggesting no critical issues impeding the facility's operations.

23Jul 25

NATCO Pharma Announces Strategic Investment in South African Pharmaceutical Giant Adcock Ingram

Natco Pharma Limited has announced plans to acquire a 35.75% stake in Adcock Ingram Holdings Limited, a major South African pharmaceutical company. The proposed deal involves acquiring 51,643,319 shares at ZAR 75.00 per share, with a total investment of approximately ₹2,000 crore. This strategic move aligns with Natco's global expansion strategy, particularly in emerging markets. The acquisition would provide Natco with entry into the South African market and access to Adcock Ingram's diverse portfolio. The transaction is subject to regulatory approvals and is expected to complete by December 31, 2025. Natco will host an investor call on July 23, 2025, to discuss the proposed investment.

23Jul 25

NATCO Pharma to Acquire 35.75% Stake in South African Pharmaceutical Giant Adcock Ingram for ₹2,000 Crore

Natco Pharma Limited has approved the acquisition of a 35.75% stake in Adcock Ingram Holdings Limited, a leading South African pharmaceutical firm, for approximately ₹2,000 crore. The deal involves purchasing 51,643,319 shares at ZAR 75.00 per share. Natco plans to establish a wholly-owned subsidiary in South Africa and liquidate its subsidiary, Time Cap Overseas Limited. The acquisition aims to expand Natco's global footprint, introduce affordable products in African markets, and leverage synergies in marketing, distribution, and R&D. Post-acquisition, Adcock Ingram will operate as a private South African business with Bidvest Group Limited holding 64.25% and Natco Pharma 35.75%. The transaction is expected to complete by December 31, 2025, subject to regulatory approvals.

19Jun 25

Natco Pharma Receives FDA Observations at Hyderabad Facilities

Natco Pharma's pharmaceutical division in Kothur, Hyderabad, received seven observations under Form 483 from the FDA. The company's API facility in Mekaguda, Hyderabad, received one procedural observation. Natco Pharma has expressed confidence in addressing these issues within the stipulated timeline.

19Jun 25

Natco Pharma's Kothur Facility Receives Seven Observations in US FDA Inspection

The U.S. FDA has completed an inspection of Natco Pharma's Kothur Pharma Division, resulting in seven observations. The exact nature and severity of these observations have not been disclosed. This inspection is crucial for Natco's ability to manufacture and export pharmaceutical products to the U.S. market. The company will likely need to address these observations to maintain regulatory compliance. The impact on Natco's operations and market access will depend on how the company responds to and resolves these observations.

16Jun 25

Natco Pharma's API Facility Clears U.S. FDA Inspection with Minor Observation

Natco Pharma's Active Pharmaceutical Ingredient (API) manufacturing facility in Mekaguda, Hyderabad, successfully completed a U.S. FDA inspection. The inspection concluded with only one observation in Form 483, indicating strong compliance with good manufacturing practices. This outcome is significant for Natco Pharma's operations and reputation in the global pharmaceutical market, particularly for its API business in the U.S. market.

13Jun 25

NATCO Pharma Receives USFDA Observation at Hyderabad API Facility; Q4 Profit Misses Estimates

Natco Pharma's API manufacturing facility in Mekaguda, Hyderabad, received one procedural observation during a USFDA inspection from June 9-13. The company plans to respond promptly. Additionally, Natco reported Q4 net profit of Rs 407.00 crore, showing 5.30% year-over-year growth, which fell short of analyst expectations.

13Jun 25

NATCO Pharma's API Plant Clears U.S. FDA Inspection with Minor Observation

Natco Pharma's Active Pharmaceutical Ingredient (API) manufacturing facility in Mekaguda, Hyderabad, has successfully completed a U.S. FDA inspection. The regulatory body issued only one observation on Form 483, indicating a positive outcome. This result reflects Natco Pharma's commitment to maintaining high quality standards and regulatory compliance, potentially facilitating future drug approvals and ensuring continued access to the U.S. pharmaceutical market.

29May 25

Natco Pharma Reports Robust Q4 Results: Net Profit Rises to ₹410 Crore

Natco Pharma announced impressive Q4 financial results, with net profit rising to ₹410.00 crore, up 6.22% year-over-year. Revenue increased by 14.23% to ₹1,220.00 crore. The company's quarterly net profit showed a significant 208.27% growth from the previous quarter. Annual performance was even more robust, with net profit up 94.09% to ₹1,388.30 crore and revenue increasing 46.78% to ₹4,126.90 crore. Operating Profit Margin improved to 43.80% from 34.56% last year.

28May 25

Natco Pharma's Q4 Profit Rises 5.3%, Falls Short of Expectations

Natco Pharma's Q4 results show a 5.3% increase in net profit to Rs 407.00 crore, with revenue rising 14.3% to Rs 1,221.00 crore. However, the company faced significant year-over-year declines in key metrics, including an 18.16% drop in revenue and a 37.75% decrease in net profit for Q4. Operating profit margin fell sharply to 8.17% from 35.34% last year. The company projects a 20% decline in revenue and a 30% drop in profit, citing increased pressures in the US market and higher R&D expenses.

08Apr 25

Natco Pharma's Risdiplam Launch Faces Legal Hurdles

Natco Pharma's plan to launch Risdiplam in India is currently on hold due to a legal dispute with Roche. The Delhi High Court initially ruled in Natco's favor, but Roche has appealed. The Appellate Bench has ordered a status quo, delaying the launch. Natco plans to price Risdiplam at ₹15900.00 MRP with additional discounts for certain patients if cleared for launch. The company is awaiting the Appellate Bench's decision before proceeding.

08Apr 25

Natco Pharma Awaits Court Clarity on Risdiplam Launch Amid Roche's Appeal

Natco Pharma is embroiled in a legal battle with Roche over the launch of Risdiplam in India. The Delhi High Court's appellate bench has ordered a status quo, delaying the launch. Despite this, Natco has announced its pricing strategy, setting the MRP at ₹15,900.00 and planning a patient access program for discounts. The company awaits legal clarity before proceeding with the launch, which has garnered significant interest from investors and patients.

25Mar 25

Natco Pharma Wins Legal Battle: Delhi HC Dismisses Roche's Plea on Risdiplam Patent

The Delhi High Court has rejected Roche's plea to prevent Natco Pharma from manufacturing and selling Risdiplam, a drug used to treat spinal muscular atrophy (SMA). This ruling allows Natco to continue its operations related to Risdiplam, despite Roche's claims of patent infringement. The decision could impact the availability and pricing of this critical SMA treatment in the Indian market.

24Mar 25

Natco Pharma Gains Upper Hand in Risdiplam Patent Case Against Roche

The Delhi High Court has dismissed Roche's plea to block Natco Pharma regarding the patent for Risdiplam, a drug used to treat spinal muscular atrophy (SMA). This ruling could allow Natco Pharma to manufacture and market its version of Risdiplam, potentially increasing accessibility and affordability of the drug for SMA patients in India and other markets. The decision marks a significant setback for Roche and could have far-reaching implications for the availability and pricing of SMA treatments.