Health Canada Grants Temporary Import Permit Through June of Next Year
, HealthCanada announced on the 24th that
it had granted permissionfor the exceptional and
temporary
Calcitriol is the active form of vitamin D, which regulates the absorption and metabolism of calcium and phosphorus in the body. However, when kidney function declines, the body cannot produce sufficient amounts of active vitamin D, which can lead to conditions such as hypocalcemia or secondary hyperparathyroidism. Bonki-ju is a prescription drug (ETC) containing calcitriol, used to treat hypocalcemia in patients undergoing chronic dialysis.
Bonki-ju is identical to the product previously approved in Canada in terms of its active ingredient (calcitriol), strength, formulation, and route of administration. Both products are intravenous solutions with a concentration of 1 mcg/mL. However, Bonki-ju is packaged in units of 10 1-mL ampoules, while the Canadian product is packaged in units of 25.
Bonki-ju does not have a Canadian Drug Identification Number (DIN) or a barcode recognized by the local drug management system. Once actual distribution begins, products labeled exclusively in Korean will be supplied to Canadian hospitals, dialysis centers, and kidney disease treatment facilities.
Consequently, Health Canada has recommended that hospitals and pharmacies attach separate stickers or supplementary labels indicating the active ingredient and strength so that the products can be accurately identified. Since the strength is labeled differently—as “1 μg” on the packaging box and “1 mcg/mL” on the ampoules—Health Canada has also issued guidelines instructing users to verify the label on the ampoule before administering the medication.
Aftera Supply Shortage
Lasting Over Two Years… Korean-Made Product Joins U.S.-Made SupplyThis measure comes in response to a supply shortage of calcitriol injections in Canada that has persisted for over two years. SteriMax, a calcitriol injection licensed in Canada, has been experiencing manufacturing disruptions since June 2024. Previously, Fresenius Kabi—which had supplied a product of the same concentration—had its sales suspended in March 2023, further limiting alternative sources of supply.
Starting in June 2024, Canada allowed the exceptional import of products approved by the U.S. Food and Drug Administration (FDA) to make up for the shortage. The authorization period for importing these products was set to expire on July 31 of this year. However, as manufacturing disruptions persisted and concerns grew that U.S. stockpiles would also be depleted, Canadian authorities upgraded the calcitriol injection shortage to a “Tier 3” supply crisis in June. Tier 3 refers to a severe supply shortage that has a significant impact on patients and the healthcare system, with limited alternative options.
The supply of Bonkizoo was initiated after a Canadian pharmaceutical importer first approached YuyuPharma. In accordance with Health Canada’s exceptional import procedures, the local importer proposed the product, and the authorities reviewed its suitability as a substitute and quality requirements before granting approval. It is believed that the fact the product shares the same active ingredient, concentration, dosage form, and route of administration as the Canadian version—and is already approved and marketed in South Korea—played a key role in its selection as an alternative supply source.
A YuyuPharma official stated, “We did not consult directly with the Canadian government; rather, we first received a proposal from a local pharmaceutical importer inquiring about the possibility of supply,” adding, “We are currently preparing the necessary documentation and customs clearance procedures for exporting the medication.”
The official added, “Once the relevant procedures are finalized, the available supply volume, the first shipment, and the arrival date in Canada will be confirmed.”
Although this move does not mean that Bonkiju has received formal product approval in Canada, if actual supply takes place, it could serve as an opportunity for YuyuPharma not only to build a track record of finished pharmaceutical product exports but also to expand its overseas client base. This is because, given that sales and the export share of injectables—including Bonkiju—are currently not significant, there is room for growth stemming from this new supply.
According to YuyuPharma’s interim report for this year, sales of injectables—including Bonki-ju—totaled 1.253 billion won in the first half of the year, accounting for 1.73% of consolidated revenue. During the same period, exports accounted for only 1.34% of sales by distribution channel.
Based on a simple estimate using domestic insurance drug prices, the price of Bonki Injection is 3,458 won per 1 mL ampoule. Assuming that hemodialysis patients receive one ampoule three times a week, the annual drug cost per patient is approximately 540,000 won. If the number of hemodialysis patients in Canada who may require this treatment is estimated at 7,400 to 12,400, the theoretical market size is calculated to be approximately 4 to 6.7 billion won annually. Although this is a simple calculation that does not reflect actual export unit prices or supply volumes, if the supply generates sales in the range of several billion won, it is expected to contribute significantly to YuyuPharma’s financial performance.
A pharmaceutical industry official stated, “Supplying Bonkiz to Canada could have a positive impact on sales and profitability in the short term, and building trust as a supplier in the local market could serve as a stepping stone to securing other overseas clients.” The official added, “However, we will need to wait until the supply volume, contract terms, and the timing of the first shipment are finalized before we can assess the specific contribution to financial performance.”
