Eirgenix Receives Approval from Japan's PMDA

EirGenix, Inc.

2020/2/14 17:25

Eirgenix Receives Approval from Japan's PMDA


TAIPEI, Feb. 14, 2020 /PRNewswire=KYODO JBN/ --

EirGenix's World-Class Biopharmaceutical Manufacturing Facility Becomes

the First of Its Kind in Taiwan to Receive Approval

EirGenix, Inc. (6589, TT) 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 site 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 2th,

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, Mainland 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.

Website: www.eirgenix.com

Source: EirGenix, Inc.