A large number of pharmaceutical companies have obtained drug registration certificates, including many of the first domestic varieties approved for marketing and evaluation

【Pharmaceutical Network Industry News】The state stipulates that drug registration is a pre-management to control drug market access and a pre-management of drug listing, with the purpose of ensuring drug quality and ensuring the safety
of human drug use.
Recently, a number of pharmaceutical companies have announced that the company's products have obtained drug registration certificates, including Jiudian Pharmaceutical, Tonghua Dongbao, Healthyuan, Tianyao Co.
, Ltd.
, China Medicine, etc
.
On November 1, Yuandong Biotechnology announced that the company's nicardipine hydrochloride injection obtained a drug registration certificate
.
Nicardipine hydrochloride injection is a new dihydropyridine calcium ion antagonist, highly selective arterial dilation to achieve rapid and stable control
of acute hypertension.
It is reported that at present, only Yuandong Biotechnology has been approved according to the registration application of new chemical class 4 in China, and it is the first enterprise
in China to pass the consistency evaluation of nicardipine hydrochloride injection 。 On October 24, Renfu Pharmaceutical issued an announcement that the propofol medium/long chain fat emulsion injection of Yichang Renfu Pharmaceutical, a holding subsidiary of the company, recently obtained a drug registration certificate, which is a short-acting intravenous general anesthetic that can be used for general anesthesia induction and maintenance in adults and children over 1 month of age; Sedation during diagnostic procedures and procedures in adults and children over 1 month of age, either alone or in combination with local or regional anesthesia; Sedation in assisted ventilation in intensive care patients over 16 years of age
.
On October 17, Tianyao issued a favorable announcement that the company's subsidiary Tianjin Jinyao Pharmaceutical Co.
, Ltd.
has a specification of 0.
1% brofenac sodium eye drops recently obtained the "Drug Registration Certificate"
.
Bromofenac sodium eye drops are a new type of non-steroidal anti-inflammatory drug, mainly used in the treatment of inflammatory diseases of the eye, such as conjunctivitis, scleritis, postoperative inflammation, etc
.
Also on the 17th, China National Pharmaceutical issued an announcement that recently, the company's wholly-owned subsidiary Tianfang Pharmaceutical's agatroban injection obtained a drug registration certificate
.
Agatroban is a novel thrombin inhibitor that inhibits fibrin formation
.
The drug is suitable for: (1) improvement of neurological symptoms (motor paralysis), daily activities (walking, standing, sitting maintenance, diet) in patients with the acute stage of ischemic cerebral infarction within 48 hours of onset; (2) improvement of limb ulcers, resting pain and cold sensation
in patients with chronic arterial occlusion (thromboangiitis obliterans, arteriosclerosis obliterans).
On October 14, Jiudian Pharmaceutical announced that the company's acetylcysteine granules obtained a drug registration certificate
.
Cysteineine is suitable for chronic bronchitis and other patients with cough with sticky sputum and is not easy to cough out, and is an OTC expectorant with wide clinical application and large
market demand.
The company said that this variety was declared according to the new registration classification 4, and it was the first enterprise
in China to pass or be deemed to have passed the consistency evaluation of the quality and efficacy of generic drugs.
On October 14, HealthYuan announced that two drugs have obtained registration certificates, namely acetylcysteine solution and tobramycin inhalation solution, the former is used to treat respiratory diseases with excessive thick mucus secretion, and the latter is suitable for bronchiectasis in adults with pulmonary Pseudomonas aeruginosa infection, controlling infection and improving symptoms, and is the first inhaled antibiotic
approved for marketing in China.
On October 11, Tonghua Dongbao announced that repaglinide tablets obtained a drug registration certificate
.
Clinically, the product is often used alone or in combination with metformin and basal insulin, and is widely used in hypoglycemic therapy
for patients with type 2 diabetes.
For these pharmaceutical companies, obtaining the product drug registration certificate means obtaining the qualification to produce the product and can circulate in the market, which is conducive to enhancing the company's market competitiveness in the field of drugs, and at the same time accumulating valuable experience
for the company's subsequent product development.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.