TAIAN CITY, Shandong, China, Sept. 4 /Xinhua-PRNewswire-FirstCall/ -- China Biologic Products, Inc. (OTC Bulletin Board: CBPO) ("China Biologic" or the "Company"), one of the leading plasma-based pharmaceutical companies in the People's Republic of China (the "PRC"), today announced that on August 6, 2008, the PRC's State Food and Drug Administration (the "SFDA") granted China Biologic's production facility in Taian City renewal of its certification of compliance with Good Manufacturing Practices ("GMP") set by the SFDA.
In January 2008, the SFDA implemented stricter pharmaceutical GMP inspection standards designed to intensify supervision of drug producers and ensure drug quality. The new inspection standards include 259 articles, up from 225 articles in the previous standards, covering areas such as the sourcing of raw materials, manufacturing processes, self-inspection processes at each stage of production and transportation.
China Biologic's newly constructed facility with 700 tons of annual production capacity for plasma-based products was certified to be in compliance with the new standards. The renewed GMP Certification replaces the current GMP certification for the production facility, which was renewed in 2004. The GMP certification is valid for five years following the date of issuance.
"Our renewed GMP certification allows us to commence production in our new facility, which we believe will position us to become a leader in the production of plasma-based products in China," said Mr. Chao Ming Zhao, the Company's CEO. "We are currently one of only 32 biopharmaceutical companies in China to hold the GMP certification to manufacture plasma-based products. We plan to maintain our compliance with GMP standards and to continue supplying high quality products to our customers."
About Chinese Good Manufacturing Practices (GMP)
The certification of GMP is an effective measure for assuring the quality, safety, and effectiveness of pharmaceutical products. GMP certification is issued by the SFDA to pharmaceutical companies in China that have met the strict standards and requirements covering organization and personnel, building and facilities, equipment, materials, hygiene and sanitation, validation, documentation, production management, quality management, production distribution and recall, complaints and adverse reactions reports and self-inspections. The GMP requirements for biopharmaceutical companies are even more stringent due to higher safety requirements.
About China Biologic Products, Inc.
Through its indirect majority-owned subsidiary Shandong Taibang Biological Products Co. Ltd., China Biologic Products, Inc. (the "Company"), is principally engaged in the research, development, production and manufacturing and sale of plasma-based biopharmaceutical products to hospitals and other health care facilities in China. The Company's human albumin products are mainly used to increase blood volume and its immunoglobulin products are used for the treatment and prevention of diseases.
Safe Harbor Statement
This release may contain certain "forward-looking statements" relating
to the business of China Biologic Products, Inc. and its subsidiary
companies. All statements, other than statements of historical fact
included herein are "forward-looking statements," including statements
regarding: the significance of the renewed GMP certification to the
Company's expansion plans; the ability of the Company to achieve its
commercial objectives; the business strategy, plans and objectives of the
Company and its subsidiaries; and any other statements of non-historical
information. These forward-looking statements are often identified by the
use of forward-looking terminology such as "believes," "expects" or similar
expressions, involve known and unknown risks and uncertainties. Although
the Company believes that the expectations reflected in these
forward-looking statements are reasonable, they do involve assumptions,
risks and uncertainties, and these expectations may prove to be incorrect.
Investors should not place undue reliance on these forward-looking
statements, which speak only as of the date of this press release. The
Company's actual results could differ materially from those anticipated in
these forward-looking statements as a result of a variety of factors,
including those discussed in the Company's periodic reports that are filed
with the Securities and Exchange Commission and available on its website (
http://www.sec.gov ). All forward-looking statements attributable to the
Company or persons acting on its behalf are expressly qualified in their
entirety by these factors. Other than as required under the securities
laws, the Company does not assume a duty to update these forward-looking
For more information, please contact:
Mr. Y. Tristan Kuo
China Biologic Products, Inc.
Investor Relations Contact:
Mr. Crocker Coulson
CCG Investor Relations
Tel: +1-646-213-1915 (NY office)
|SOURCE China Biologic Products, Inc.|
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