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.
Source: EirGenix, Inc.