Announcement on the Holding Subsidiary's Obtaining of the "Drug GMP Certificate"
Release time:
2021-05-20
Securities Code: 600668 Securities Abbreviation: Jianfeng Group Announcement No.: Pro 2019-034
Bond Abbreviation: 13 Peak 02 Bond Code: 122344
Zhejiang Jianfeng Group Co., Ltd.
Announcement
for the authenticity, accuracy and completeness of its contents.
Recently, Zhejiang Jianfeng Group Co., Ltd. (hereinafter referred to as "the company") holding subsidiary Zhejiang Jianfeng Pharmaceutical Co., Ltd. (hereinafter referred to as "Jianfeng Pharmaceutical")
received the "Drug GMP Certificate" issued by Zhejiang Food and Drug Administration. The relevant information is hereby announced as follows:
1. GMPCertification Related Information
Enterprise Name: Zhejiang Jianfeng Pharmaceutical Co., Ltd.Address: No. 58
Certificate No.: ZJ20190116
Certification Scope: powder injection (including cephalosporins) and freeze-dried powder injection
certification date: 2019
10 31
valid: 202410 30
2. GMPCertificate Involving Production Line
| Production Line Name |
Design Annual Capacity |
Main Variety |
| Powder Injection Production Line |
about 2000 |
cefmenoxime hydrochloride for injection, cefoxitin sodium for injection |
| freeze-dried powder injection production line |
about 1000 |
penciclovir for injection, for injection ribavirin |
| Drug Name |
Dosage Form |
Therapeutic Field |
Manufacturer |
| Injection Cefmenoxime Hydrochloride |
Powder Injection (Including Cephalosporins) |
Anti-infection |
Shanghai Shangyao Xinya Pharmaceutical Co., Ltd., Liaoning Haisco Pharmaceutical Co., Ltd., Hainan Tianhuang Pharmaceutical Co., Ltd., Hainan Lingkang Pharmaceutical Co., Ltd. and Jianfeng Pharmaceutical Co., Ltd. and other 10 . |
| Injection Cefoxitin Sodium |
Powder Injection (Including Cephalosporins) |
Anti-infection |
Harbin Pharmaceutical Group Pharmaceutical General Factory, Guangdong Bozhou Pharmaceutical Co., Ltd., Sichuan Pharmaceutical Preparation Co., Ltd., Shandong Luoxin Pharmaceutical Group Co., Ltd. and Jianfeng Pharmaceutical Co., etc. 49 home. |
| Penciclovir for Injection |
Freeze-dried Powder Injection |
Antivirus |
Ruiyang Pharmaceutical Co., Ltd. and Jianfeng Pharmaceutical . |
Ribavirin for Injection |
Freeze-dried Powder Injection |
Antivirus |
Shanghai Shangyao Xinya Pharmaceutical Co., Ltd., Zhejiang Asia Pacific Pharmaceutical Co., Ltd., Haikou Qili Pharmaceutical Co., Ltd., Hainan General Kangli Pharmaceutical Co., Ltd. and Jianfeng Pharmaceutical Co., Ltd. 209 7 . |
, "Major Manufacturers " information in the above table mainly comes from the website of china food and drug administration;
4. Impact on Listed Companies and Risk TipsThe "GMP
Certificate" obtained by Jianfeng Pharmaceutical Co., Ltd. this time is that its original GMP certificate for powder injection and freeze-dried powder injection production line expires and obtains the certificate after re-certification. Re-obtaining the GMP certificate will help ensure the production capacity of the above-mentioned products and ensure the continuity of market supply. It will not have a significant impact on the Company's current operations. The future sales of various drugs of
Company may be affected by the market environment, industry policies, supply and demand and other factors, with certain uncertainties. Please the majority of investors cautious decision-making, pay attention to prevent investment risk.hereby announce
Zhejiang Jianfeng Group Co., Ltd.
Board of Directors
November 6
, 2019
More information
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2020
07-31
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)
2020
07-31
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)
2020
07-31
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