echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > An inventory of injection varieties of top 4 pharmaceutical enterprises exported to the United States

    An inventory of injection varieties of top 4 pharmaceutical enterprises exported to the United States

    • Last Update: 2019-07-26
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    In 2018, China's export of Western medicine products reached US $36.883 billion, of which the export of Western medicine preparations reached US $4.100 billion, an increase of 18.64% year on year In all drug export dosage forms, injection is directly injected into the body for use, and the quality standards of such dosage forms exported to countries that regulate the market are the most stringent FDA's strong supervision of sterile injection has brought a highly centralized and uncompleted injection generic market, and compliance injection generic has become a scarce resource with high threshold and high income According to statistics, at present, there are only 8 domestic pharmaceutical enterprises that have obtained FDA injection anda, among which only 4 pharmaceutical export enterprises, Hengrui pharmaceutical, Jianyou Co., Ltd., Qilu pharmaceutical and Puli pharmaceutical, have the ability to continuously supply to the U.S market Data source: FDA Hengrui Pharmaceutical Co., Ltd in December 2011, the antitumor drug irinotecan injection produced by Hengrui Pharmaceutical Co., Ltd passed the FDA certification in the United States, becoming the first injection made in China listed and sold in the United States In recent years, Hengrui pharmaceutical has continuously increased its R & D investment, built a quality system in accordance with American FDA standards, and promoted the internationalization strategy of "going global" of domestic preparations Up to now, Hengrui pharmaceutical has a total of 10 FDA approved injection anda numbers, ranking first with Jianyou Co., Ltd It is a leading enterprise in the internationalization of injection products in China, among which many injection varieties have achieved large-scale sales The export injection products are mainly anti-tumor drugs and anesthetics, which is the dominant product field of Hengrui pharmaceutical Data source: FDA, the company announced that Jianyou Co., Ltd is a pioneer enterprise in the internationalization of injection products in China Jianyou started to arrange the international projects of injection as early as 2010, taking products such as enoxaparin injection and standard heparin injection as the first batch of application products At present, Jianyou has 3 injection production lines that have passed the FDA certification, and 10 FDA injection andas have been approved, including 2 andas of Nanjing Jianyou and 8 andas of Chengdu Jianjin Among them, heparin sodium injection series is the core product of Jianyou, with 8 specifications, covering the mainstream specifications of heparin sodium products that have been listed in the United States The product chain revolves around enoxaparin / standard heparin, and extends to small molecule anti-tumor drugs, anesthesia, anti infection and other injection products Source: FDA, the company announced that Qilu pharmaceutical has been promoting its internationalization strategy in recent years, and its products export has expanded from APIs to preparations In the field of injection export to the United States, the first anda ondansetron hydrochloride injection was approved in September 2014 At present, Qilu pharmaceutical has obtained 8 FDA approved anda products, mainly in the field of anti infection and anti-cancer Source: FDA, the company announced that Puli pharmaceutical, as one of the earliest companies to explore the internationalization of preparations in China, began to export preparations in 2005, focused on the export varieties of generic drugs for injection at the beginning, and began to transform the injection workshop according to FDA standards in 2008 Up to now, Puli pharmaceutical has more than 30 approval numbers for overseas preparation production, and there are 6 kinds of aDNA for injection in the United States, which is later than the approval time of the first three injection products It is worth mentioning that vancomycin approved by Xinjin in the United States is the first approved heavy-duty injection variety of Puli pharmaceutical In 2018, Bloomberg terminal sales data exceeded US $600 million At present, vancomycin hydrochloride for injection is in short supply in the United States, and the listing of Puli pharmaceutical is expected to bring new performance growth points for the company's export products Source: FDA, the company announced that the double benefits of injection from domestic pharmaceutical companies to the United States are good for domestic consistency evaluation The announcement of the opinions of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs involves the following contents: the drugs produced and listed in the same production line in China and approved to be listed in the European Union, the United States or Japan shall be deemed to have passed the consistency evaluation after being reviewed and approved by the consistency evaluation office Under the consistency evaluation policy, local pharmaceutical enterprises that have obtained approval documents from overseas can enter the fast channel of "priority evaluation" by virtue of the policy, surpass other domestic pharmaceutical enterprises through consistency evaluation, seize the market opportunity, and obtain a better pricing and competition pattern According to the data of minenet, as of June this year, including 6 injection products of Hengrui pharmaceutical, bensulfonaatracurium injection, docetaxel injection, irinotecan hydrochloride injection, dexmedetomidine hydrochloride injection, oxaliplatin for injection, cyclophosphamide for injection and 5 injection products of Qilu pharmaceutical, ondansetron hydrochloride injection, irinotecan hydrochloride injection, injection Oxaliplatin, ceftriaxone sodium for injection and cefepime hydrochloride for injection have all been declared by way of export to China When the evaluation standard for consistency of injection in China has not yet been issued, these injection products are expected to take the lead in passing the consistency evaluation in China and enjoy the policy dividend in advance, laying a foundation for the future performance growth of the enterprise Winning the overseas incremental market a few days ago, the National Medical Security Bureau held a video conference on DRG payment, and officially announced the list of 30 pilot cities for DRG payment, which the insiders call the ultimate big move for China's medical insurance control Under the background of increasingly strict domestic medical insurance fee control policy, the contradiction between medical service accessibility and cost control will continue to deepen, accompanied by the negative pressure of the overall growth of the pharmaceutical industry in the future; at the same time, we can see that the United States, as the world's largest generic drug market, is currently facing a serious injection drug shortage The comprehensive effect of the above two factors is both an opportunity and a challenge for domestic pharmaceutical enterprises For the domestic injection manufacturers with strength, taking the opportunity of the internationalization of injection products, aiming at the high-end standardized market, entering their products into the largest market of generic drugs in the world, and actively seeking new incremental market space, this is an excellent way to meet the challenge of domestic medical insurance cost control and maintain future growth.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.