Notice on GMP Certification of Subsidiary Company
Release time:
2020-08-05
Securities Code: 600668 Securities Abbreviation: Jianfeng Group Announcement No.: 2018-014
Bond Abbreviation: 13 Peak 01 Bond Code: 122227
Bond Abbreviation: 13 Peak 02 Bond Code: 122344
Zhejiang Jianfeng Group Co., Ltd.
Prompt Announcement on the Certification of Subsidiary GMP
The Board of Directors and all directors of the Company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and shall bear individual and joint liabilities for the authenticity, accuracy and completeness of its contents.
Recently, the website of Zhejiang Food and Drug Administration (hereinafter referred to as ZJFDA ) announced the "Zhejiang Drug GMP Certification Announcement (2018 050 )". (See http://zw.zjfda.gov.cn/topics!new_detail.do?id=4293 for details).
is approved by on-site inspection and examination in accordance with the provisions of the State Food and Drug Administration's "Administrative Measures for the Certification of Pharmaceutical Production Quality Management Standards" and the "Notice on the Implementation of the" Pharmaceutical Production Quality Management Standards (2010 Revision) "(State Food and Drug Administration [2011 ] 101 ), the production line of the bulk drug (artificial bezoar) of Zhejiang Jianfeng Pharmaceutical Co., Ltd., a subsidiary of the Company, has met the requirements of the Good Manufacturing Practice for Pharmaceuticals (2010 Revision) and agreed to issue the GMP Certificate for Pharmaceuticals .
At present, the company has not received the relevant certificate, and the relevant information is hereby announced as follows:
certificate number: ZJ20180050 ;
Enterprise Name: Zhejiang Jianfeng Pharmaceutical Co., Ltd.;
Address: No. 61 368 , Jinqu Road, Jinhua Industrial Park, Zhejiang Province;
Certification Scope: Raw Material Drug (Artificial Niuhuang);Valid until:
2023 5 2 .
Please be cautious in making decisions and pay attention to investment risks.hereby announces
Zhejiang Jianfeng Group Co., Ltd. Board of Directors
May 5, 2018
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Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
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