NATCO Pharma Ltd.

BERKELEY HEIGHTS, N.J., March 2, 2026 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc., the U.S. subsidiary of Towa International that markets, distributes, and sells generic medicines in the United States, announced the launch of Pomalidomide Capsules, a generic version of Pomalyst® by Celgene (now Bristol Myers Squibb), within the oncology therapeutic category. The product was developed in collaboration with NATCO Pharma Limited of India. With this launch, Breckenridge strengthens its commitment to supporting patients with complex medical conditions by delivering high-quality, affordable treatment options to those who need them most. Breckenridge's introduction of Pomalidomide Capsules also further expands the company's specialty oncology generics portfolio. Pomalidomide Capsules, a thalidomide analogue, is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. It is also approved for AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy, as well as for HIV-negative adult patients with Kaposi sarcoma. The product is available in 1 mg, 2 mg, 3 mg, and 4 mg strengths and is distributed primarily through specialty pharmacies and clinics. Full prescribing information, including boxed warnings for Breckenridge's Pomalidomide Capsules, is available here. Pomalidomide Capsules are available only through a restricted program called PS-Pomalidomide REMS. "Access and affordability continue to be major challenges for patients who depend on specialty therapies," said Brian Guy, President and Chief Commercial Officer of Breckenridge Pharmaceutical, Inc. "Breckenridge's launch of Pomalidomide Capsules delivers a high-quality, affordable generic solution, supported by copay assistance for eligible patients to help reduce treatment delays and ensure continuity of care. This milestone underscores Breckenridge's ongoing commitment to expanding our specialty generics portfolio and improving access to affordable therapies for patients with complex conditions." Additionally, Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer of NATCO Pharma Limited said: "We are pleased to launch Pomalidomide Capsules in the U.S. This further strengthens our oncology and specialty portfolio in the U.S. The launch highlights our commitment to our mission of making specialty medicines accessible to all the patients worldwide. We look forward to bringing more such complex and specialty products to the market in the coming years." *All brand names and trademarks are the property of their respective owners. About Breckenridge Pharmaceutical, Inc.: Breckenridge Pharmaceutical, Inc., (New Jersey), the U.S. subsidiary of Towa International (Barcelona, Spain), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we strive to impact the health of the patients we and our customers serve. About NATCO Pharma Limited: NATCO Pharma Limited, (NSE:NATCOPHARM, BSE: 524816, Reuters: NATP.NS, Bloomberg: NTCPH,) headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven, leading Oncology player in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. The Company's manufacturing facilities are approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets. For more information, please visit us at . SOURCE Breckenridge Pharmaceutical, Inc. 21% more press release views with Request a Demo

Mumbai|New Delhi: The commerce ministry and the ministry of health are in extensive deliberations over the issue of inclusion of data exclusivity or protection provisions in the proposed drug regulatory and legal framework, senior industry officials told ET. The matter has gained prominence in the last few weeks amid extensive lobbying by domestic drug industry groups, civil society, patient advocacy groups, and pharma multinationals. All the concerned parties made opposing claims to senior officials in the ministries on how data protection provisions could impact access to lifesaving drugs for Indian patients. "An inter-departmental secretary level meeting was held recently but there was no consensus," one of the officials said. "There is a positive indication on the acceptance of data protection in the regulatory provisions," a second official added. A third official termed it as an area of ongoing discussions, hinting a final decision has yet to be taken, and that the Centre may eventually explore a middle path, ensuring data protection for a specific term with certain caveats. The issue of data protection hit the spotlight recently after commerce minister Piyush Goyal, highlighted that the India-EFTA Trade and Economic Partnership Agreement (TEPA) entails an investment commitment of $100 billion over 15 years and the creation of one million jobs. The four members of the European Free Trade Association (EFTA) are Switzerland, Iceland, Norway, and Liechtenstein. The investment commitment from the four-nation bloc, officials said, is partly predicated on India's acceptance of data exclusivity or protection norms. Data exclusivity ensures protection of drug tests and other data originating from the research of an invention of drug or therapy by an innovator or originator company. While the matter pertains to the health ministry and the department of pharmaceuticals, the commerce ministry's Department for Promotion of Industry and Internal Trade (DPIIT) is also looking at it as the request came from EFTA. "The EFTA bloc has been requesting for a provision for regulatory data protection or the data which is generated as a result of clinical trials so as to encourage innovator companies and promote an innovative environment in India," a commerce ministry official said. "Preliminary discussions are going on," the official said, adding no proposals have been made by the Centre so far on the issue. To secure marketing approval for a new drug, pharma firms must submit the data or clinical trial results to the local regulator for its review process. However, global drug makers contend that the same data developed over years of rigorous trials and forming the basis of approvals is used by subsequent filers or generic drug makers who skip such trials or bioequivalence studies, securing an easy path to gaining regulatory approvals. This October, the Drug Controller General of India (DCGI) invited views on the "lack of level playing field", as the government intended to review data protection laws. According to a submission accessed by ET, the Organisation of Pharmaceutical Producers of India (OPPI), a lobby group comprising multinational pharma companies, has sought a provision of ten- year data protection for small molecules and 12 years for biological products. It stressed that this was in line with its European partners that grants ten-year data protection. "The government is considering a five-year data protection," said a senior industry official. However, Indian drug makers contend that data exclusivity is a layer of protection separate from patent rights. "Data exclusivity can block generic competition, delay competition, and price reduction, which would deprive patients of medicines at affordable prices," an official said. "A 1-3 year or 3-5 year data exclusivity period after an originator medicine is licensed is being considered," the person said. "Certain American companies have proposed a 10-12 year data protection period and the protection to start from the date when they apply for in India, not globally. European majors have sought around a 6-8 year exclusivity period". The Working Group on Access to Medicines and Treatments, a patient advocacy group, underlined that having data exclusivity in India would have delayed by several years the launch of affordable versions of Swiss drugmaker Roche's Risdiplam, used for treating spinal muscular atrophy (SMA), denying countless SMA patients access to a lifesaving treatment. "Data exclusivity will not be just a technical tweak; it will be a direct threat to the survival of many people," the group cited a patient as saying. India's Natco Pharma launched generic versions of Risdiplam at ₹15,900 per bottle, fraction of Roche's price of ₹6 lakh, following a favourable court verdict recently. By Vikas Dandekar , Kirtika Suneja & Teena Thacker ,

Mumbai: Hyderabad-based NATCO Pharma API manufacturing plant located in Manali, Chennai has received a form 483 with seven observations from the US Food and Drugs Administration ( FDA ). In a intimation to the stock exchange the drugmaker disclosed, following an inspection bu the US regulator from November 17–21, the company received seven observations in the Form-483. Without disclosing the nature of observations NATCO said that the raised observations are procedural in nature and is confident to address them comprehensively. An observation under the Form 483 is issued, if the FDA observes that certain conditions may violate the Food, Drug, and Cosmetic (FD&C) Act or related laws. By Online Bureau ,