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Pharmaceutical Network February 1st, January 29th, NMPA official website shows that Colum Pharmaceuticals' compound amino acid (15AA-I)/glucose electrolyte injection, omega-3 fish oil/long-chain fat emulsion injection was approved for the market.
compound amino acid (15AA-I)/glucose electrolyte injection for the domestic first imitation, omega-3 fish oil / long-chain fat emulsion for the second domestic.
two products are intestinal nutrition drugs, currently Colum Pharmaceuticals has been approved for the market of 10 intestinal nutrition drugs.
compound amino acid (15AA-I)/glucose electrolyte injection is an amino acid glucose ready-to-use intestinal nutrition double-chamber bag developed for BXT, which is suitable for providing energy, protein and electrolytes to patients who need extraintestinal nutrition when intraintestinal nutrition is not viable, inadequate or taboo.
columine pharmaceutical compound amino acid (15AA-I)/glucose electrolyte injection for the first imitation in China.
/long-chain fat emulsion in omega-3 fish oil is a single bottle of fat milk variety for fat supplementation in patients who are not fully functional or who are unable to ingest nutrients through the mouth/intestine.
the original research manufacturer of this product for the German Braun, health yuan in December 2020 won the first domestic imitation, Colum Pharmaceuticals for the second domestic.
intestinal nutrition plays an important role in the treatment of patients with critical injury and severe trauma, which can quickly provide the nutrients needed by the body, promote the recovery of patients and improve the prognostics of the disease.
With the approval of these two products, the current Colum Pharmaceuticals approved the listing of 10 intestinal nutrition drugs, covering a single bag (bottle), double-room bag, three-cavity bag packaging form, further enhance the company's market competitiveness in the field of intestinal nutrition.
m.com data show that six intestinal nutrition drugs have been evaluated by/as consistently as available, including fatty lactose (17) glucose (11%) injections, fatty lactate (17) glucose (19%) injections, compound amino acids (1) 6AA-II.)/glucose (48%) electrolyte injection, medium/long-chain fat emulsion (C8-24Ve), compound amino acids (15AA-I)/glucose electrolyte injection, omega-3 fish oil/long-chain fat emulsion injection, etc.
It is worth mentioning that Colon Pharmaceuticals also has four applications for the listing of extraintestinal nutrition drugs in the review and approval, namely, omega-3 fish oil medium long chain fat milk / amino acids (16)/ glucose (36%) injections, omega-3 fish oil medium long chain fat Milk/amino acids (16)/glucose (30%) injections, medium-long-chain fat milk/amino acids (16)/glucose (36%)injections, medium-long-chain fat milk/amino acids (16)/glucose (30%) injections.
Colum Pharmaceuticals in the review and approval of intestinal nutrition drug source: MED2.0 China Drug Review Database 4 varieties are copied 3 categories of production, after approval will be treated as a review.
addition, the four varieties in the domestic market have not been approved for listing, and for the exclusive production of Colum Pharmaceuticals, is expected to be the first approved listing.
source: Minet database, company announcement