The Production Line of UBI Pharma for Manufacturing Sterile Injectable Drugs Has Been Approved by the U.S. Food and Drug Administration

The Hsinchu Plant of UBI Pharma (6562) received a routine GMP inspection combined with a pre-approval inspection for a sterile injectable drug conducted by the U.S. Food and Drug Administration (FDA) from June 10 to June 20, 2019. The company received the Establishment Inspection Report (EIR) issued by the U.S. FDA on August 12, 2019 with a positive conclusion of VAI (voluntary action indicated), which will benefit the future operation of the company.


UBI Pharma stated that because of the high standards in sterile injectable drug manufacturing and the increasingly stricter international regulations, many international injectable drug manufacturers failed to comply with the current GMP standards and have closed. In the United States, injectable drugs accounts for approximately 70% of the drug shortages. In addition, according to the 2017 U.S. Specialty Injectables Market Report, the specialty injectable market size of the U.S. in 2016 was US$8 billion. The market is projected to reach US$12 billion by 2019 at a compound annual growth rate (CAGR) of 14.9%.


The Hsinchu Plant of UBI Pharma has passed several official inspections conducted by the regulatory authorities of the U.S. and Japan since the first inspection conducted by the U.S. FDA in 2012. This inspection was the fifth inspection conducted by the U.S. FDA and the plant passed the inspection of the production line for manufacturing sterile injectable drugs for the fourth time. Passing the inspection not only grants UBI Pharma a permit to continue selling its injectable pharmaceutical products to the United States, but demonstrates that UBI Pharma is highly competitive in the international market in terms of its capabilities to meet requirements for regulations, quality and technology.


In addition to the self-developed injectable products exported to the United States, UBI Pharma has also been commissioned by several pharmaceutical companies in the U.S. and Europe to develop and manufacture a number of injectable products. The Hsinchu Plant of UBI Pharma has started a commercial production and exported the products to the United States since 2019 after our corporate partner in the U.S. received a license for injectable products in 2018. Meanwhile, several self-developed products and a number of products commissioned by the clients will also be submitted for ANDA filing to the US FDA in the near future.