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Pharmaceutical Network August 7th, Hengrui Pharmaceuticals to copy 4 types of reported inhalation of heptafluorane into the administrative approval stage. according to
-meter net data, in 2019 China's public medical institutions terminal inhalation of heptafluorane sales of more than 2 billion yuan, an increase of 8.71 percent year-on-year.
the product has not yet been evaluated by enterprises.
Figure 1: Heptafluorane in inhalation with heptafluorane registration progress inhalation is a halogen-based inhalation general anaesthetic, clinically applicable to adult and pediatric patients in-hospital surgery and outpatient surgery general anesthesia induction and maintenance.
the product was first developed by Abbott, was approved for listing in the United States in June 1995, the patent has expired for many years, Baxter and India's Piramal company heptfluorane generics were approved in the United States in July 2002 and May 2007, respectively.
currently has 6 domestic enterprises (3 domestic, 3 imports) have the inhalation of heptafluorane production approval, minet data show that in 2019 China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) terminal inhalation of heptofluoride sales of more than 2 billion yuan, an increase of 8.71 percent year-on-year.
table: Inhalation heptafluorane consistency evaluation declaration 3 enterprise layout inhalation with heptafluorane consistency evaluation, Hengrui Pharmaceuticals not only submitted a consistency evaluation supplement application, but also with a new classification of production, acceptance number CYHS1900766 has entered the New Deal approval stage;
November 10, 2015, Hengrui Pharma announced that the company's production of inhalation heptafluorane through the U.S. FDA certification, approved for sale in the U.S. market.
through the "foreign transfer to the domestic" way, Hengrui to foreign registration application spending relevant information in the domestic declaration, no longer need to carry out BE test.
benefitfrom this approach, the company's other inhaler inhalation land fluoran has been approved for production in July 2018, although reported as a generic 6, but has been included in the China Listed Drugs Catalog, and is therefore considered to be through a consistent evaluation.
Figure 2: Inhalant evaluation situation Minet net data show that at present, six inhalers have been evaluated by enterprises, including inhalation with sulphate salbutamol solution, inhalation with budined mixed suspension of the number of enterprises are up to 2;
5 of the 6 over-rated inhalers were respiratory medications, inhaled with sulphate sulfateol solution, inhalation with budinamine mixed suspension, compound isopropyl bromine anti-ammonium inhalation solution, hydrochloric acid l-salbutamol inhalation solution are anti-asthma drugs, inhalation of hydrochloric acid amordinso solution for cough and cold drugs;
source: Minnet database, The State Drug Administration Note: data statistics as of August 6, if there are omissions, welcome to point!