Announcement on the Holding Subsidiary's Obtaining of the "Drug GMP Certificate"
Release time:
2020-08-05
Securities Code: 600668 Securities Short Name: Jianfeng Group Announcement No.: Pro 2018-026
Bond Short Name: 13 Jianfeng 02 Bond Code: 122344
Announcement of Zhejiang Jianfeng Group Co., Ltd.
on the acquisition of the "Drug GMP Certificate" by the holding subsidiary
The board of directors and all directors of the company guarantee this announcement There are no false records, misleading statements or major omissions, and they are individually and jointly liable for the authenticity, accuracy and completeness of their 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 Zhejiang Food The "Drug GMP Certificate" issued by the Drug Administration. The relevant information is hereby announced as follows:
1. GMP Certification Related Information
Enterprise Name: Zhejiang Jianfeng Pharmaceutical Co., Ltd.
Address: No.
Certificate No.: No. 368 Jinqu Road, Jinhua Industrial Park, Zhejiang Province: ZJ20180081
Certification Scope: Eye Drops, Ear Drops
Valid: august 2, 2023
2. involves production line capacity and main products:
Production Line Name |
Design Annual Capacity |
Variety |
Eye Drops Production Line |
Million |
Sodium Hyaluronate Eye Drops |
Ear Drops Production Line |
.5 Million |
Ofloxacin Ear Drops |
Market Situation of Main Products of 3. Company
Drug Name |
Dosage Form |
functional indications |
main manufacturer |
sodium hyaluronate eye drops |
eye drops |
are used for Sjogren's syndrome, Sjogren's syndrome, xerophthalmia |
towering pharmaceutical (China) co., ltd ; Qilu Pharmaceutical Co., Ltd.; Zhuhai Federal Pharmaceutical Co., Ltd. Zhongshan Branch; |
Ofloxacin Ear Drops |
Ear Drops |
is used to treat otitis media, otitis externa and tympanitis caused by sensitive bacteria |
Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd; Nanjing Tianlang Pharmaceutical Co., Ltd.; Wuhan Wujing Pharmaceutical Co., Ltd.; |
Note: 1. The information of "Main Manufacturers" in the fourth column of the table mainly comes from the website of china food and drug administration.
2, 2017, peak pharmaceutical sodium hyaluronate eye drops sales revenue of 15.9176 million yuan, the sales revenue of ofloxacin ear drops was 1.2665 million yuan.
Impact of 4. on Listed Companies and Risk Tips
The "Drug GMP Certificate" obtained by Jianfeng Pharmaceutical this time is not the certification certificate of the new production line, but the certificate obtained after the GMP certificate of its original eye drop and ear drop production line expires and is re-certified. Obtaining the GMP certificate again will help ensure the product quality and production capacity of Jianfeng Pharmaceutical, ensure market supply, and will not have a significant impact on the company's current operations. The specific future sales of various drugs of
Company may be affected by market environment, industry policy, supply and demand relationship and other factors, with uncertainty. Please the majority of investors cautious decision-making, pay attention to prevent investment risk.
is hereby announced.
Zhejiang Jianfeng Group Co., Ltd. Board of Directors
August 14, 2018
More information
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2020
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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)
2020
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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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