Eirgenix Receives PMDA Approval

Eirgenix Receives PMDA Approval

EirGenix’s world-class biopharmaceutical manufacturing facility becomes the first of its kind in Taiwan to receive approval.

EirGenix, Inc. had undertaken the transfer of drug substance manufacturing of a marketed drug from a Japanese pharmaceutical company and has since fulfilled all the regulatory requirements necessary to complete the manufacturing transfer.

The independently administered Pharmaceutical and Medical Devices Agency (PMDA), under Japan’s Ministry of Health, Labour, and Welfare, carried out its on-site inspection of EirGenix’s biopharmaceutical manufacturing facility from September 9th to September 12th, 2019.

A successful inspection and approval from PMDA would authorize EirGenix to sell back the manufactured drug substance to its Japanese client to ultimately be sold on the Japanese market.

On February 3rd, 2020, EirGenix received PMDA’s official approval in its issued ‘GMP Compliance Inspection Result Notification’, proclaiming EirGenix’s compliance with relevant Japanese regulations regarding the quality, effectiveness and safety of pharmaceutical manufacturing.

The approval from PMDA represents a remarkable milestone for both EirGenix and Taiwan, as EirGenix’s facility becomes the first GMP biopharmaceutical manufacturing facility in Taiwan to receive the authority’s approval.

EirGenix now stands amongst a small, select group of biopharmaceutical manufacturers in Asia that have earned PMDA’s approval. Having reached such an astonishing achievement has highlighted the rapid growth of EirGenix’s contract development and manufacturing (CDMO) services to world-class quality standards.

The exciting news will be sure to stimulate the interest and confidence of both Japanese and other international companies in contracting its CDMO service needs to EirGenix.

In the past year, EirGenix has experienced substantial growth in its business with its 2019 revenue easily surpassing the year prior. Overseas revenue has grown the most rapidly with total overseas revenue to domestic revenue ratio now reaching a staggering 4 to 1.

EirGenix’s CDMO business in the Japanese market has continually and steadily grown over the years and is the largest contributor to overseas revenue. It is without a doubt that EirGenix’s revenue from its CDMO business will grow even more rapidly in the coming years as even more Japanese and other international companies turn their focus towards EirGenix as a potential service provider.

Passing PMDA’s inspection represents EirGenix’s first international “stamp of approval” that attests to EirGenix’s rise in attaining the international standards of other global players.

EirGenix has been providing CDMO services since its establishment in 2013. In less than 7 years, the company has seen its operating income grow to a record high of 400 million New Taiwan Dollars in 2019, with its gross profit also reaching a record high.

This year, EirGenix will continue to undertake even more contracts entrusted to it by international biotech and pharmaceutical companies from all over the world, including Japan, the United States, China, and Europe. In its pioneer years, EirGenix primarily served the local Taiwanese market, but quickly expanded its business outside Taiwan to become the international CDMO company it is today.

Now with the announcement of PMDA’s authorization for EirGenix to manufacture marketed drug substances in Japan, EirGenix further expands its offerings to a more robust service life cycle, from early-stage research and development up to commercial manufacturing of marketed products.

EirGenix’s greater one-stop CDMO service offerings are certain to provide it with the competitive advantage to compete with other international companies on the global market.