Securities code: 300630 securities abbreviation: Hainan Poly Pharm.Co.Ltd(300630) Announcement No.: 2022-011
Bond Code: 123099 bond abbreviation: Puli convertible bond
Hainan Poly Pharm.Co.Ltd(300630)
About Anhui Puli Pharmaceutical Co., Ltd., a wholly-owned subsidiary, received
Announcement of FDA and EDQM receiving notification letter
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Anhui Puli Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Hainan Poly Pharm.Co.Ltd(300630) (hereinafter referred to as ” Hainan Poly Pharm.Co.Ltd(300630) ” or “the company”), has recently received the notification letters of receipt of DMF and CEP applications for magnesium hydroxide API issued by the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) and the European Drug Quality Administration (hereinafter referred to as “EDQM”), and the relevant information is hereby announced as follows:
1、 Basic information of products
(I) product name: magnesium hydroxide
(II) dosage form: API
(III) DMF No.: 036567
(IV) CEP related No.: CEP 2022-010
(V) holder: Anhui Puli Pharmaceutical Co., Ltd
2、 Other relevant information of the product
Magnesium hydroxide is a salt laxative with anti acid effect. Its preparation is mainly used for gastric / duodenal ulcer, gastritis (sudden / chronic gastritis, drug-induced (including gastritis), upper gastrointestinal dysfunction (anorexia nervosa, including so-called gastroptosis and hyperacidity).
Up to now, according to the public information on EDQM and FDA websites, there are three companies in the world that have obtained CEP certificates for magnesium hydroxide API, and the DMF of two companies, including Anhui Puli, is in “a” status in FDA. Anhui Puli has a commercial production capacity, which will further enrich the company’s product line and enrich the varieties of API.
The company’s registration of magnesium hydroxide API in other markets is also continuing.
3、 Risk tips
The company attaches great importance to drug research and development, and strictly controls the quality and safety of drug research and development, manufacturing and sales. Due to the characteristics of high technology, high risk and high added value of pharmaceutical products, not only the early research and development of drugs and the long cycle and many links of products from research, approval to production, but also the production and sales of drugs after obtaining approval are vulnerable to some uncertain factors. The company will timely fulfill the obligation of information disclosure according to the follow-up progress. Please make careful decisions and pay attention to preventing investment risks.
4、 Documents for future reference
(I) supporting documents
Hainan Poly Pharm.Co.Ltd(300630)
Board of directors
January 24, 2022
