Medigen Vaccine Biologics Corporation (6547-TW), after obtaining new drug marketing authorization from Vietnam's Drug Administration of Vietnam (DAV) in the first half of this year, has completed quality inspections and batch release procedures, initiating the first export of its vaccine to Vietnam today (4th). The shipment is expected to arrive in Vietnam and begin contributing to revenue from August 2023, with subsequent batches to be delivered continuously throughout the year.
The company's self-developed enterovirus type 71 vaccine, 'Envivac,' received marketing authorization from Vietnam's regulatory authority on March 17, 2023, marking the first official approval for an enterovirus vaccine issued by the Vietnamese government.
To ensure full compliance with international Good Distribution Practice (GDP) standards during cross-border transportation, Medigen has adopted 'active temperature-controlled containers.' Equipped with precise digital temperature control and independent power systems, these containers effectively eliminate potential variables from long-haul air transport and external climate conditions. This ensures that each dose remains under constant temperature protection from the manufacturing site in Taiwan to arrival in Vietnam, maintaining the same quality as at出厂 (time of release).
FACT BOX
- Source: PR Times
- Category: New Product