Source: Chemical mesh Synthesis
Introduction: Recently, Baiyun Mountain chemical API Pofol Tenofovir fumarate was approved for listing, Hisun Pharmaceutical API oseltamivir phosphate was approved for listing, Xinhua Pharmaceutical API prednisone was approved for listing, Lyme Pharmaceutical API Nicodil was approved for listing, Shijiazhuang Siyao Group API norepinephrine bitartrate was approved, and Aodong Pharmaceutical API Piperoxili was approved for listing.
Baiyunshan chemical API Pofol tenofovir fumarate was approved for market
Recently, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. branch Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Chemical Pharmaceutical Factory received the State Drug Administration approved and issued profol tenofovir fumarate chemical raw material listing application approval notice.
Propofol tenofovir fumarate is a drug used to inhibit hepatitis B virus, which was approved by the US FDA in November 2017 under the trade name Vemlidy for the treatment of patients with chronic hepatitis B infection with compensatory liver disease. In December 2022, Baiyunshan Chemical Pharmaceutical Factory submitted the application for registration and listing of apis to the State Food and Drug Administration and was accepted. After inquiry, the main manufacturers of pofol tenofovir fumarate apis in China are Shandong Lonuo Pharmaceutical Co., LTD., Anhui Anke Hengyi Pharmaceutical Co., LTD., Jilin Huikang Pharmaceutical Co., LTD. Data show that in 2022, the domestic sales revenue of pofol tenofovir fumarate preparations is about 1.5 billion yuan. The approval notice of the application for the listing of Pofol tenofovir fumarate chemical raw material indicates that the raw material has met the relevant national drug evaluation technical standards and can be produced and sold, which helps to enrich the types of antiviral products of Baiyunshan Chemical Pharmaceutical Factory and enhance the company’s market competitiveness in the field of antiviral.
Hisun Pharmaceutical’s oseltamivir phosphate API was approved for marketing
On February 28, Hisun Pharmaceutical Nantong Co., LTD., a wholly-owned subsidiary of Hisun Pharmaceutical, received the “Notice of Application for Approval of the Listing of Chemical apis” of oseltamivir phosphate approved and issued by the State Drug Administration.
Oseltamivir phosphate is a precursor drug to its active metabolite (oseltamivir carboxylate), a selective influenza virus neuraminidase inhibitor used for the treatment of influenza A and B in adults and children 1 year and older, and for the prevention of influenza A and B in adults and adolescents 13 years and older.
The oseltamivir phosphate API of Haizheng Nantong Company passed the technical evaluation of the Drug Evaluation Center of the State Food and Drug Administration, proving that the API has met the relevant national drug approval technical standards and can be produced and sold, which is conducive to further enriching the company’s product line and enhancing market competitiveness.
Xinhua Pharmaceutical prednisone API approved for market
Recently, Xinhua Pharmaceutical hormone varieties prednisone received the State Drug Administration approved and issued the “Chemical raw material drug Listing application Approval Notice”. Previously, the company’s products have been registered in many international markets such as Europe and the United States.
This product has anti-inflammatory and anti-allergic effects, can inhibit the proliferation of connective tissue, reduce the permeability of capillary wall and cell membrane, reduce inflammatory exudation, and inhibit the formation and release of histamine and other toxic substances. When severe toxic infection, combined with a large number of antibacterial drugs, can have a good cooling, anti-toxic, anti-inflammatory, anti-shock and promote symptom relief. This product is an adrenocortical hormone drug, and its tablets have been included in the “National Essential Drugs Catalogue” (2018 edition), and belong to the “National Basic Medical Insurance, industrial injury insurance and maternity insurance drug Catalogue (2023)” A variety.
The prednisone API independently developed by Xinhua Pharmaceutical was approved, which is another hormone product after prednisone acetate, hydrocortisone and prednisone, further enriching the company’s hormone API product structure, and providing continuous, stable and reliable API sources for domestic and foreign preparation production.
Lyme Pharmaceutical nicodil API approved for marketing
Recently, Chongqing Lemme Longyu Pharmaceutical Co., LTD. (hereinafter referred to as “Lemme Longyu”), a wholly-owned subsidiary of Chongqing Lemme Longyu Pharmaceutical Co., LTD. (hereinafter referred to as “Lemme Longyu”), received the State Drug Administration’s approval and issuance of nicodil (specification: 4.00kg/ bag, 1 bag/bottle) “Chemical Raw Material Drug Listing Application Approval Notice”, registration number: Y20220000621, Notice No. : 2024YS00170.
Nicodil for injection, mainly used for unstable angina pectoris and acute heart failure, can improve coronary microcirculation, effectively reduce cardiovascular events, and significantly reduce the risk of acute coronary syndrome, and clinical patients can benefit a lot. Nicodil was developed by domestic and foreign pharmaceutical Co., LTD. Nicodil tablets and injections were approved by the Japanese Pharmaceutical and Medical Device General Organization in 1983 and 1993 respectively, and Nicodil tablets were approved in China in 2005. At the same time as Lemme Longyu’s application for nicodil API, Lemme Pharmaceutical also submitted an application for the listing of related preparations of the product to the State Drug Administration
Shijiazhuang Siyao Group raw material drug norepinephrine bitartrate was approved
On February 29, the norepinephrine bitartrate declared by Shijiazhuang Siyao Group Hebei Guangxiang Pharmaceutical Co., Ltd. was approved by the State Food and Drug Administration and registered as a raw material drug used in listed preparations. This is the fourth new API approved by the group in the first two months of this year, and the development of API has entered the “fast track” of development. Norepinephrine bitartrate is an adrenergic receptor agonist used for blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, sepsis, blood transfusion, and drug response).
Up to now, Shijiazhuang Siyao Group has been approved this year Lidocaine hydrochloride, Resagiline mesylate, isoproterenol hydrochloride, norepinephrine bitartrate 4 new API varieties, a total of 50 API varieties, variety structure is increasingly rich.
In recent years, Shijiazhuang Siyao Group has taken the lead of innovation drive, anchored the national strategic development needs, actively promoted the integrated business strategy of “API + preparation”, deployed the innovation chain around the industrial chain, and in-depth promoted the research and development of high-end complex generic drugs, innovative drugs and other preparation products, combined with domestic and foreign market demand. Actively promote the development of special apis and the international certification of products. At present, the development proportion of characteristic API varieties in the research of new products is increasing, and the industrialization progress is accelerating, which has become a new highlight of the innovation and development of enterprises.
“Innovation helps promote transformation, optimize structure, improve energy levels, achieve ‘breaking the circle’ to break through, and accelerate the extension of the API innovation chain to the middle and high-end.” The relevant person in charge of the group said that the innovation of API research and development and the transformation of results have accelerated the improvement of quality and efficiency, the increasing number of characteristic advantageous varieties, and the supporting role of specialized and special new “little giant” has been strengthened, which has effectively promoted the new jump in the diversification of enterprise product structure.
Aodong Pharmaceutical chemical raw material Piperoxili was approved for market
Recently, Jilin Aodong Pharmaceutical Group Co., LTD., a holding subsidiary of Jilin Aodong Taonan Pharmaceutical Co., LTD., received three “Drug Registration Certificates” and “Chemical raw material Application Approval Notice” issued by the State Drug Administration of Piperoxili capsule specifications: 100mg, 75mg, 125mg.
Indications for Piperacilli capsules: This product is indicated for hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative local advanced or metastatic breast cancer, and should be used in combination with aromatase inhibitors as an initial endocrine therapy in postmenopausal women.
The approval of Piperoxili capsules and piperoxili apis has improved the company’s product structure, further enriched the company’s apis and capsule preparations, enhanced the company’s core competitiveness, and created favorable conditions for the company’s further development.
