Tranexamic Acid Import | Stable Supply of Overseas Transamin Injections and Oral Medications | TASAKI PHAMA

The Importance of Tranexamic Acid and the Current State of Domestic Supply

Tranexamic acid is a synthetic amino acid with anti-plasmin activity and a wide range of pharmacological effects, including hemostatic, anti-inflammatory, and anti-allergic properties. In clinical settings, it is used to treat a variety of conditions, such as postoperative bleeding control, menorrhagia associated with dysmenorrhea, eczema and urticaria, and melasma. In particular, it is widely used as an oral medication for the treatment of melasma, greatly contributing to the improvement of patients’ quality of life (QOL).

However, in recent years, there have been frequent shipping adjustments for tranexamic acid products in Japan, especially Tranexamic acid injection, raising concerns about stable supply in the medical field. Various factors can be considered behind these shipping adjustments, such as manufacturing issues and a surge in demand. The inability to secure the necessary amount of medication when needed not only affects patients’ treatment plans but also can hinder the operation of medical institutions.

In response to this situation, there is a growing need from medical institutions for the import of overseas tranexamic acid products. The introduction of overseas products can supplement the instability of domestic supply and be an effective means of continuing treatment for patients. In particular, for medical institutions looking for alternatives to Tranexamic acid injection, importing from overseas is an urgent issue.

Supply Status of Tranexamic Acid Injection

Tranexamic acid injection is an essential drug for controlling bleeding during surgery or trauma. However, currently, stable supply is difficult in Japan, and medical institutions are forced to explore alternative means. As specific alternative drugs, agents with similar anti-plasmin activity or direct therapeutic agents for the cause of bleeding are considered, but it is not always possible to obtain the same effect as Tranexamic acid injection.

Supply Status of Tranexamic Acid Oral Medication

Tranexamic acid oral medication is mainly used for the treatment of melasma. In Japan, products such as Transino are widely known, but their supply may also become unstable. As an alternative to oral medication, combination drugs containing ingredients such as vitamin C and L-cysteine in addition to tranexamic acid may be used.

Options for Overseas Tranexamic Acid Products

Overseas, there are tranexamic acid products equivalent to those distributed in Japan. These products do not differ significantly from domestic products in terms of active ingredients, dosage, administration, efficacy, and effectiveness. However, since product names, manufacturers, and packaging differ, sufficient information gathering is required for introduction.

Overseas tranexamic acid products include both injections and oral medications. As injections, for example, there are products manufactured in Europe and some Asian countries. Similarly, as oral medications, generic drugs are manufactured in various countries. These products are manufactured and sold based on the pharmaceutical regulations of each country and meet certain standards regarding quality and safety.

When selecting overseas products, the following points should be noted:

• Product quality: Reliability of the manufacturer, manufacturing standards (GMP, etc.)
• Pharmaceutical regulations: Regulations of the importing country, regulations of the selling country
• Availability: Securing a stable supply route
• Price: Comparison with domestic products, import costs

It is important to comprehensively judge this information and select a product that meets the needs of your hospital.

Examples of Specific Overseas Tranexamic Acid Products

Specific drug names vary depending on the pharmaceutical regulations and sales status of each country, so only the generic name will be mentioned here. As overseas tranexamic acid injections, there are products manufactured in Europe and some Asian countries. These products are used for controlling bleeding during surgery or hemostasis during trauma, similar to domestic Tranexamic acid injection. In addition, as oral medications, generic drugs are manufactured in various countries and used for the treatment of melasma.

FDA and EMA Approval Status

Tranexamic acid is approved as a drug in many countries and is also approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Approval by these agencies suggests that the product meets certain standards regarding safety and efficacy. However, when importing overseas products, it is necessary to comply with the pharmaceutical regulations of the importing country.

Points to Note When Importing Overseas Pharmaceuticals

There are various points to note when importing overseas pharmaceuticals. First, it is necessary to comply with the pharmaceutical regulations of the importing country. Importation of pharmaceuticals may require permission or approval. Also, stricter regulations may apply when importing as a medical institution rather than as a personal import.

Next, it is necessary to ensure product quality. Overseas products may have different quality control standards compared to domestic products. It is important to check the reliability of the manufacturer and manufacturing standards (GMP, etc.) and select products with guaranteed quality.

Furthermore, it is necessary to secure a stable supply route. The price and supply of overseas products may fluctuate depending on import conditions and exchange rates. It is desirable to diversify risks by securing multiple suppliers.

Finally, there is the issue of language. The package inserts and instruction manuals for overseas products may be written in a foreign language. It is necessary to use translation services to understand accurate information.

Compliance with the Pharmaceuticals and Medical Devices Act (PMD Act)

The import of pharmaceuticals is strictly regulated by the Pharmaceuticals and Medical Devices Act (PMD Act). Importing or selling pharmaceuticals without permission is a violation of the law. When importing pharmaceuticals, it is necessary to comply with the PMD Act and obtain the necessary permits and approvals.

Quality Control and Storage Methods During Import

Imported pharmaceuticals require appropriate quality control and storage methods. Pharmaceuticals that are easily affected by temperature, humidity, light, etc. must be stored in an appropriate environment. Also, pharmaceuticals with expired expiration dates must be discarded without use.

Conclusion: Toward a Stable Supply of Tranexamic Acid

Tranexamic acid is an important drug with a wide range of pharmacological effects, including hemostatic, anti-inflammatory, and anti-allergic properties, and is widely used in clinical settings. However, in recent years, domestic supply has become unstable, and medical institutions are forced to explore alternative means.

The import of overseas tranexamic acid products can supplement the instability of domestic supply and be an effective means of continuing treatment for patients. However, the import of overseas pharmaceuticals has various points to note, such as compliance with pharmaceutical regulations, quality control, and securing a stable supply route.

Medical institutions need to fully understand these points and carefully consider the introduction of overseas products. In addition, the government and related organizations need to take measures to ensure a stable supply of tranexamic acid. Specifically, strengthening the domestic manufacturing system, strengthening cooperation with overseas suppliers, and developing alternative drugs can be considered.

A stable supply of tranexamic acid is essential for improving patients’ QOL. It is important for medical institutions, the government, and related organizations to cooperate and work toward building a stable supply system.