Who Owns Tirosint?

Tirosint operates under IBSA Institut Biochimique SA's comprehensive sustainability framework, which the company has integrated into all aspects of its operations from research and development to production and logistics. IBSA published its seventh Sustainability Report for 2024, demonstrating the company's commitment to responsible growth and adherence to European Sustainability Reporting Standards (ESRS) rather than voluntary standards.

Environmental Responsibility: IBSA has implemented systematic environmental monitoring and management across its manufacturing facilities in Switzerland and Italy. The company has strengthened its operational resilience and improved risk management, particularly in the supply chain, with enhanced monitoring of environmental issues. IBSA's sustainability initiatives include reducing environmental impact through improved manufacturing processes and adopting more sustainable practices throughout its operations.

Ethical Manufacturing and Quality Standards: Tirosint is manufactured under current Good Manufacturing Practice (cGMP) regulations with strict quality control measures. IBSA maintains high ethical standards in its pharmaceutical operations, ensuring compliance with regulatory requirements and maintaining transparency in its manufacturing processes. The company's commitment to ethics extends to all aspects of its business operations, from clinical development to commercial distribution.

Social Responsibility and Community Engagement: IBSA has intensified opportunities for interaction with patients and medical professionals, demonstrating its commitment to stakeholder engagement. In 2024, the company introduced a corporate volunteering program, emphasizing individual responsibility and common benefit. The company's sustainability approach permeates every aspect of corporate strategy, including initiatives aimed at improving employee well-being and generating positive community impact.

Transparency and Accountability: IBSA's adoption of ESRS standards enhances the comparability and reliability of ESG data while ensuring the integration of sustainability into corporate strategies and operations. This systematic approach fosters a corporate culture where ethics, transparency, and social and environmental responsibility guide daily decisions across all business units, including Tirosint manufacturing and distribution.

Tirosint has received recognition primarily for its pharmaceutical innovation in drug delivery technology rather than traditional industry awards. The brand's significance lies in its pioneering approach to levothyroxine formulation, addressing important clinical needs for patients with hypothyroidism.

FDA Innovation Recognition: Tirosint's softgel capsule formulation represents a significant innovation in levothyroxine drug delivery, offering an excipient-free alternative to conventional tablets. The FDA approval of Tirosint under NDA 021924 acknowledged the novel formulation approach that addresses absorption issues and sensitivities to inactive ingredients experienced by some patients with conventional levothyroxine tablets.

Formulation Technology Leadership: IBSA's PEARLtec technology, used in Tirosint's softgel capsule manufacturing, has been recognized within the pharmaceutical industry for improving oral medication intake and patient compliance. This technology enables the incorporation of a liquid matrix into a continuous soft gelatin shell, enhancing both medication delivery and patient experience compared to traditional tablet formulations.

Clinical Innovation Impact: Tirosint has been acknowledged by endocrinology specialists and thyroid healthcare providers for its clinical utility in managing hypothyroidism, particularly for patients with gastrointestinal absorption issues or sensitivities to tablet excipients. The brand's inclusion of multiple dosage strengths (13 mcg through 200 mcg) demonstrates comprehensive patient-centered design that has been recognized within the medical community.

Patient-Centric Design Recognition: The development of Tirosint-SOL as a liquid levothyroxine solution represents additional innovation in patient care, particularly for pediatric patients and those with dysphagia. This dual-formulation approach (capsule and liquid) has been noted as a significant advancement in personalized thyroid hormone replacement therapy.

Tirosint has experienced one significant product recall that affected its liquid formulation but not the softgel capsule product. The recall was handled voluntarily by the manufacturer and did not result in reported adverse events.

Tirosint-SOL Voluntary Recall (2023): IBSA Pharma announced a voluntary recall on January 31, 2023, for 27 lots of Tirosint-SOL (levothyroxine sodium oral solution) due to potential subpotency issues. The recall affected only the liquid formulation and did not apply to Tirosint softgel capsules. The affected lot numbers were 220409, 220956, 220856, 220552, 221055, 220553, 221056, 220407, 220960, 220556, 221058, 220853, 220411, 220854, 220413, 220964, 220414, 220852, 220970, 220855, 220415, 221052, 220959, 220416, 221053, 220418, and 220560.

Risk Assessment and Patient Safety: The FDA classified this as a Class I recall due to the potential for subpotent doses. Adults with hypothyroidism using subpotent levothyroxine sodium could experience symptoms of hypothyroidism, including fatigue, increased sensitivity to cold, constipation, dry skin, facial puffiness, hair loss, slow heart rate, depression, thyroid gland swelling, and unexplained weight gain or difficulty losing weight. However, IBSA Pharma reported no adverse events related to the recall.

Recall Management and Communication: IBSA Pharma promptly notified wholesalers, retailers, and healthcare providers to stop distributing the affected lot numbers. The company established a patient and provider hotline (1-800-587-3515) available Monday through Friday from 9 a.m. to 7 p.m. Eastern Standard Time, plus an email contact ([email protected]) for recall-related inquiries. Patients were advised to continue taking their medication until consulting their healthcare provider for guidance or replacement prescriptions.

Regulatory Compliance: The recall was conducted in cooperation with FDA guidelines, with proper reporting through the FDA's MedWatch Adverse Event Reporting program. IBSA's transparent handling of the recall, including clear communication with healthcare providers and patients, demonstrated appropriate regulatory compliance and patient safety protocols.