Recently, Tonghe Pharmaceutical issued an announcement that the APIs mirabelon and rivaroxaban passed the drug GMP (Good Manufacturing Practice) compliance inspection
.
It is understood that miraberon is a selective β3-adrenoceptor agonist, which can improve bladder filling and urinary storage capacity by activating β3-adrenal receptors on the detrusor muscle of the bladder, and is clinically used to treat overactive bladder with symptoms such as urge urinary incontinence, urgency, and frequent urination
.
Rivaroxaban is a novel anticoagulant that is widely used in the prevention and treatment of venous thromboembolic disease and stroke prevention
of non-valvular atrial fibrillation.
Tonghe Pharmaceutical said that the API mirabelon and rivaroxaban passed the drug GMP compliance inspection, which is conducive to expanding the sales of products in the domestic market and forming a good pattern
of synchronous sales in domestic and foreign markets.
In addition to passing the GMP compliance inspection of drugs, there is also good news that many companies have been approved for marketing APIs recently
.
On October 19, Xinhua Pharmaceutical issued an announcement that the marketing application of the chemical API prednisolone was approved, and furosemide injection (2ml: 20mg) passed the consistency evaluation
of the quality and efficacy of generic drugs.
Prednisolone is an adrenal corticosteroid drug, with anti-inflammatory, anti-allergic and immunosuppressive and other pharmacological effects, mainly used for allergic and autoimmune inflammatory diseases, collagen diseases, such as rheumatism, rheumatoid arthritis, lupus erythematosus, various adrenal insufficiency, etc
.
Relevant database statistics show that in 2021, the global sales of prednisolone preparations will be about 1 billion US dollars, and the consumption of APIs will be about 80 tons
.
On October 18, Tuoxin Pharmaceutical announced that the cyclophosphoadenosine API of Xinxiang Pharmaceutical Co.
, Ltd.
, a wholly-owned subsidiary, received the "Notice of Marketing Application Approval for Chemical APIs"
issued by the State Medical Products Administration.
Cyclophosphoadenosine is a vasodilator included in the Chinese Pharmacopoeia for angina pectoris, myocardial infarction, myocarditis and cardiogenic shock
.
According to public information, Xinxiang Pharmaceutical submitted an application for marketing registration of chemical APIs to the Evaluation Center of the State Food and Drug Administration in January 2021, which was officially accepted on February 6, 2022, and received a domestic marketing application approval notice on October 14
, 2022.
The cyclic adenosine API passed the technical review of the Drug Evaluation Center of the State Food and Drug Administration, marking that Xinxiang Pharmaceutical has obtained the qualification for the domestic market of the API, which is expected to have a positive impact
on the domestic market of Xinxiang Pharmaceutical.
On the same day, Sinopharm Modern issued an announcement that Sinopharm Jiangsu Wichida API Dapoxetine Hydrochloride received the "Chemical API Marketing Application Approval Notice"
issued by the State Food and Drug Administration.
Prior to this, Lifang Pharmaceutical also announced that it had received a notice of acceptance for the marketing registration of
nifedipine APIs.
The drug preparation is mainly used clinically for the treatment of hypertension, coronary heart disease, chronic stable angina (exertional angina), etc
.
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