RV Group, a Southeast Asian company, is moving forward with a sterile injectables expansion in Vietnam. Sudeshna Pan, General Director, RV Group, Vietnam provided an update at the DCAT Member Company Announcement Forum at DCAT Week.  

The company is operational in countries of the Association of Southeast Asian Nations (ASEAN), the Commonwealth of Independent States (CIS) and North Africa. It has three manufacturing facilities: an EU-GMP facility in India; an EU-GMP facility in Vietnam, and a WHO-GMP facility in Myanmar. It has more than 4,500 employees.  

The company acquired OPV Vietnam, a WHO-GMP manufacturing plant in 2021 and proceeded with upgrades. In September 2024, after over two years of upgrades, the company successfully completed an EU-GMP  audit of the facility. In the existing site, with an 2,000-square-meter-floor area, the company is investing $20 million to set up an EU/WHO- GMP compliant sterile injectable (aseptic) facility for monoclonal antibodies and peptides for prefilled syringes, vials, and cartridges. The facility will use ready-to-use) prefilled syringes, vials, stoppers and caps with a single combined line machine with a robotic arm system for operations. The facility will manufacture products, such as trastuzumab, bevacizumab, pegfilgrastim, semaglutide, and enoxaparin products for the first time in Vietnam. It will further strengthen RV Vietnam’s presence in oncology and biosimilars. 

The lyophilizer selection is planned to be based on 2-mL vials with a batch size of 12,000 vials, 5,000 vials batch for 10 mL, and 1,500 vials batch for 50 mL, with a 48-hour freeze-drying cycle. Accordingly, the company is proposing a three-square meter shelve area lyophilizer. 

In the first phase, the company will manufacture drug products from drug substances. The memorandum of understanding for the supply of drug substances of all the selected products are in place. In the second phase, the manufacturing from cell line to drug product will be done in-house. 

The expansion project is ongoing, where-by the layouts have been finalized and equipment’s ordered. Operations will be started by the first quarter of 2026. The project is in line with the new Pharma Law (2025) of Vietnam that identified biological manufacturing is prioritized for investment,  and products are subject to fast-track and streamlined appraisal procedures.