The company is a pharmaceutical and biopharmaceutical consultancy based in Asia, with subsidiaries in Oceania. Established in 2012, it specializes in GMP consulting, regulatory services for small molecules and biosimilars, vendor qualification, third-party audits, technical due diligence, and portfolio strategy. Certified under ISO 9001:2015 for quality management, the company offers comprehensive regulatory support, including dossier preparation, submissions, and approvals for markets such as the US, EU, WHO PQP, and emerging regions. It has expertise in biosimilars, vaccines, and quality compliance, managing EU GMP and PIC/S projects, and conducting technical due diligence for investment projects.
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PARECOXIB SODIUM
Parecoxib Sodium is water-soluble, injectable sodium salt form of Parecoxib, an amide prodrug of the
cyclooxygenase II selective, non-steroidal anti-inflammatory drug (NSAID) Valdecoxib, with anti-
inflammatory, analgesic, and antipyretic properties. After entering the body, Parecoxib is hydrolyzed
by hepatic carboxyesterases to its active form, valdecoxib to binds to and inhibits COX-2. These
actions of Parecoxib Sodium prevents the conversion of arachidonic acid into prostaglandins, which
are responsible for the regulation of pain, inflammation, and fever. Parecoxib Sodium does not inhibit
COX-1 at therapeutic concentrations and thus does not interfere with blood coagulation.
Parecoxib, sold under the brand name Dynastat among others
Monsanto led by John Talley discovered Parecoxib, along with other COX-2 selective inhibitors,
celecoxib, valdecoxib, and mavacoxib. Parecoxib was patented in 1996 and approved for medical use
in 2002. However, In 2005, the U.S. Food and Drug Administration issued a letter of non-approval for
parecoxib in the United States. No reasons were given for the non approval.
Forms and Dosage
Each Powder vial of Parecoxib contains 40 mg Parecoxib and After reconstitution, the concentration
of Parecoxib is 20 mg/ml. Every 2 ml of reconstituted powder contains 40 mg of parecoxib. The
normal recommended adult dose is a single 40 mg dose administered intravenously or
intramuscularly. However, for elder patients weighing less than 50 kgs, the prescribed dosage is 20
mg only.
The cost Parecoxib Sodium
When bought in its chemical form PS costs between 5000 and 16,000 USD per kilo. Whereas the
tablets, whereas the 100 mg vial costs USD 240.
How does it work?
PS belongs to a group of medicines called coxibs. Their main action is relieving pain and
inflammation. Following injection, parecoxib sodium is rapidly converted to valdecoxib which inhibits
cyclooxygenase-2 mediated prostaglandin synthesis. In the process, Valdecoxib reduces the
production of prostaglandins needed as mediators of pain and inflammation. If administered at
recommended doses in acute pain management, the onset of analgesia was 7–14 minutes and
reached a peak effect within 2 hours.
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