Bora Group is committed to upholding ethical principles in the sale and promotion of drugs. We are committed to protecting customer privacy, implementing high-quality pharmacovigilance, and ensuring that marketing practices comply with local regulations to achieve patient safety and transparency.
The U.S. is the core of Bora Pharmaceuticals’ dual-engine strategy, which encompasses CDMO and global commercial sales. Currently, 95% of our revenues are generated outside Taiwan, primarily in North America.
To deepen our footprint in this vital market, Bora acquired the century-old, renowned American drugmaker Upsher-Smith Laboratories (USL) in 2024. USL provides robust local manufacturing and distribution networks, alongside a steadfast commitment to quality and compliance, making it the cornerstone of our responsible sales operations in the U.S.
Therefore, this section focuses on USL’s operational metrics, demonstrating how Bora upholds the highest standards of patient safety and ethical marketing in our largest global market.
Responsible Marketing Policy
The interaction among medical professionals is subject to the PhRMA Code of Conduct and the Upsher-Smith Code of Business Conduct. These standards shape the expectations toward education activities, events, sponsorships, and catering, and they ensure compliance with state and federal laws. Ethical interaction with the medical community is a cornerstone of Upsher-Smith’s operations.
In 2025, Upsher-Smith’s business and marketing department achieved a 100% training completion rate, demonstrating the commitment of the Company to ethical interactions with medical professionals and patients. About 20 sales and marketing staff members completed the mandatory training, with each participant receiving an average of approximately 2 hours of compliance and ethics training.
This commitment is reflected in our performance: Upsher-Smith did not receive any complaints about unfair trade practices or privacy abuses in 2025.
| Responsible Marketing Training | Result |
|---|---|
| Training completion rate | 100% |
| Staff completing mandatory training | About 20 sales and marketing staff |
| Average training hours per participant | About 2 hours |
| Complaints on unfair trade practices or privacy abuse | 0 |
Pharmacovigilance (PV)
Patient safety is a cornerstone of our operations. We maintain a comprehensive post-market safety monitoring system, with a robust adverse drug reaction surveillance framework as its support. This ensures that all adverse events, no matter whether they are learned from any complaint channels, are collected and assessed systematically, and are reported to the U.S. Food and Drug Administration (FDA) within the legally required time frame.
By integrating diverse information-receiving channels into our safety system, we are able to implement continuous risk signal detection, proactive risk management, and consistent legal compliance. Operationally, Upsher-Smith uses a wide range of reporting channels, including:
- Online reporting via a dedicated drug safety mailbox
- Fortrea Medical Information Contact Center
- Dedicated product and medical information hotline
- Specialty pharmacy partners; risk assessment and control plan (REMS)
- Adverse drug reaction surveillance agreement partners
- Literature screening and reports forwarded by the U.S. FDA
For case processing, Upsher-Smith engages its pharmacovigilance service partner, Fortrea, to perform front-end operations: upon receiving a report, Fortrea registers eligible cases in the Intake and Registration Management System (IRMS) and processes and conducts an initial assessment of them in Argus, the safety database widely used across the industry. Upsher-Smith adverse drug reaction surveillance team then performs the sponsor review and approves the submission of final reports, while Fortrea manages follow-up activities.
In addition, regular reconciliation with reporting partners ensures data completeness, and the processing timelines of all cases are continuously monitored through the drug safety case tracking system to maintain regulatory compliance.
| Pharmacovigilance Performance | Cases | On-time Compliance Rate |
|---|---|---|
| Total adverse event reports received | 1,042 | — |
| 15-day reports (expedited safety reports filed with the FDA within 15 days) | 663 | 99.55% |
| Non-15-day reports (periodic or non-expedited submissions) | 251 | 98.01% |
Product Recall Management
| FDA Health Hazard Classification | Description |
|---|---|
| Class I | There is a reasonable probability of serious injury or death. |
| Class II | It is likely to cause reversible or temporary harm. |
| Class III | It is unlikely to cause adverse reactions. |
Anti-counterfeiting and Serialization
- Unit-level serialization: All salable units on the packaging line are printed with a 2D DataMatrix barcode, which clearly indicates a unique serial number, product identification code, batch number, and expiration date.
- Aggregation: Hierarchical linking of serialization data from individual units to cartons and pallets can significantly improve the visibility of the entire supply chain.
- Data exchange and verification: Performing information integration with trading partners through the EPCIS system can ensure the transparency of the source and the prevention of counterfeit drugs from reaching patients.
Ethical Marketing and Practices / Customer Privacy
| Item | 2023 | 2024 | 2025 |
|---|---|---|---|
| Legal proceedings, fines, or settlements related to improper marketing, anti-competitive practices, or off-label promotion | 0 | 0 | 0 |
| Related financial losses | 0 | 0 | 0 |
| Data breaches | 0 | 0 | 0 |
| Confirmed privacy complaints | 0 | 0 | 0 |
Product Recall and Complaint Handling
To uphold consumer trust, the company has developed “Complaint Handling SOPs” and “Recall Handling SOPs”. These procedures ensure prompt investigation and effective corrective actions.
In 2024, Bora received 6 reports related to packaging defects or appearance. None affected safety, and no recalls were required.