Huons Accelerates Entry into Canada with Three Local Anesthetics... Export Contract Signed
[Asia Economy Reporter Lee Gwan-joo] Huons' three types of 'local anesthetics' (1% lidocaine ampoule, 1% lidocaine vial, 0.75% bupivacaine ampoule), which passed the U.S. Food and Drug Administration (FDA) gateway, have now officially entered the Canadian market.
On the 12th, Huons announced on the 13th that it held an export contract signing ceremony for the three local anesthetics to Canada at its headquarters in Pangyo, Seongnam-si, Gyeonggi Province, attended by CEO Yoon Sang-bae and Mangubat Lee, CEO of Canadian FPI (Formative Pharma Inc.).
The exported items under the contract are ▲ 5ml ampoule of 1% lidocaine hydrochloride injection ▲ 2ml ampoule of 0.75% bupivacaine hydrochloride injection ▲ 5ml vial of 1% lidocaine hydrochloride injection. These items obtained U.S. FDA ANDA (Abbreviated New Drug Application) approvals in April 2018, December 2019, and May 2020, respectively.
This contract was made as Canadian FPI actively requested the export agreement. CEO Lee said, "Huons' injections, which boast excellent quality to the extent of passing the U.S. FDA, are expected to have competitiveness and market breakthrough power in the Canadian generic injection market," adding, "Large pharmaceutical companies are experiencing continuous supply shortages due to management difficulties, so there are many opportunities."
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Huons plans to quickly obtain approval from Health Canada in cooperation with FPI. They aim to start the approval submission within the second quarter of this year and expect to enter the local market by the third quarter of next year. A Huons official said, "Taking this contract as an opportunity, we plan to discuss expanding the product lineup to target the Canadian generic sterile injection market with FPI," adding, "Since the Canadian pharmaceutical bio market is still unfamiliar to domestic companies, we expect many new entry opportunities."
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