Halocarbon has Built a Legacy of Innovation in Anesthesia
Halocarbon is a company built on firsts. As one of the world’s leading producers in specialty fluorochemicals, Halocarbon has a track record in inhalation anesthesia that spans over 30 years. Most notably, Halocarbon was the first U.S. based producer of Halothane for operating rooms. Subsequently, Halocarbon has invested in substantial capacity and capabilities for Isoflurane and Sevoflurane. As a result, Halocarbon has over 20 years’ of experience manufacturing Isoflurane and over 10 years’ of experience as a Sevoflurane manufacturer.
The Advantages of Bottled Sevoflurane
The global market for inhalation anesthesia is over $1.3 billion, and after the departure of Halothane, the market is now dominated by three main products: Sevoflurane, Isoflurane, and Desflurane. Sevoflurane is a volatile anesthetic agent that is administered to induce or maintain general anesthesia. Today, it captures 70% of the market. The demand for inhalation anesthesia is poised to increase as a result of the growing prevalence of chronic diseases from a rapidly aging population, and an increase in the number of ambulatory surgeries being performed. Sevoflurane is the most common agent for day-case surgeries due to its speedy rate of induction, rapid recovery profile due to low gas solubility, and a greater control of depth of anesthesia. Additional advantages include low flammability, minimal cardiovascular and respiratory side effects, and a non-pungent odor.
Your New Bottled Sevoflurane Supply Option
Until recently, the market has been supplied by only a handful of sevoflurane manufacturers. Today, Halocarbon offers the global marketplace a new supply option. Through early 2017, Halocarbon’s shipments of Sevoflurane and Isoflurane were in bulk API format. Now that Halocarbon has developed its new bottling capacity, the company can directly ship bottled Sevoflurane and Isoflurane to the global marketplace.
In addition to the new bottling line, Halocarbon offers the most vertically integrated cost structure of any Sevoflurane manufacturer in the world, making Halocarbon very cost competitive. This means pharmaceutical companies, distributors, and hospitals have a new supply option for bottled Sevoflurane and Isoflurane.
Halocarbon Bottled Sevoflurane is FDA Approved
Halocarbon is one of only five producers approved by the FDA to manufacture and sell bottled Sevoflurane. In order to obtain FDA approval, Halocarbon demonstrated the stability of Sevoflurane in its approved container closure system. Data submitted showed stability in amber glass bottles under standard accelerated conditions (bottles stored at 40ºC and 75% relative humidity for 3 months). In addition, Halocarbon even submitted data that show stability under more stressful conditions (60ºC and less than 5% relative humidity for 3 months). Stability testing and additional research produced no evidence that storing Sevoflurane in a type III glass in Lewis Acid formation contributes to the decomposition of Sevoflurane.
The FDA approved Halocarbon’s Sevoflurane as a therapeutic equivalent to Ultane and lists Sevoflurane in their “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the “Orange Book.” Packaged in a 250mL USP Type III amber glass container, Halocarbon’s Sevoflurane has a shelf life of 36 months. Halocarbon also offers Sevoflurane for veterinary use.
Thanks to its new bottling capacity, vertically integrated cost position, and FDA approvals, Halocarbon is positioned to become a leading supplier of bottled Sevoflurane and Isoflurane to the global market. Halocarbon not only offers competitive prices but is backed by over 30 years of experience in the inhalation anesthesia market. Contact Halocarbon to discuss how we can meet your bottled Sevoflurane needs.
Ready to talk? Connect with our sales manager, Jeff Clements.
