Parecoxib API Manufacturers & Suppliers
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Parecoxib | CAS No: 198470-84-7 | GMP-certified suppliers
A medication that provides short-term perioperative pain relief with anti-inflammatory effects through selective COX-2 inhibition, suitable for injectable formulation in surgical settings.
Therapeutic categories
Primary indications
- Used for short term perioperative pain control
Product Snapshot
- Parecoxib is available as an injectable small molecule formulation, including lyophilized powder for solution and ready-to-use solutions for parenteral administration
- It is primarily indicated for short-term perioperative pain control
- The compound is approved for use in key regulatory markets including the European Union and the United States
Clinical Overview
Clinically, parecoxib is approved in the European Union under the brand name Dynastat for short-term management of perioperative pain. Its injectable formulation allows administration in patients who are unable to take oral medications, notably in the perioperative setting. While it occupies a similar therapeutic niche as ketorolac in the United States, parecoxib has not been approved by the US Food and Drug Administration; the FDA issued a letter of non-approval in 2005.
Pharmacologically, parecoxib acts as a prodrug, rapidly converted to its active form valdecoxib following intravenous or intramuscular administration. Metabolism primarily involves cytochrome P450 enzymes, including CYP2C9 and CYP3A4 isoforms. Its pharmacokinetic profile supports short-term use, typically limiting treatment duration to reduce the risk of adverse effects.
Safety considerations include risks associated with COX-2 selective inhibition such as potential for hypertension, hyperkalemia, and nephrotoxicity. As with other NSAIDs, caution is advised in patients with compromised renal function, cardiovascular risk factors, or electrolyte imbalances. Monitoring is recommended during therapy to mitigate these safety concerns.
From an API sourcing perspective, quality attributes for parecoxib include high purity, controlled polymorphic form, and water solubility to ensure consistent prodrug activation and clinical performance. Suppliers should provide comprehensive Certificates of Analysis and adhere to Good Manufacturing Practice (GMP) guidelines to assure quality and regulatory compliance for pharmaceutical manufacturing.
Identification & chemistry
| Generic name | Parecoxib |
|---|---|
| Molecule type | Small molecule |
| CAS | 198470-84-7 |
| UNII | 9TUW81Y3CE |
| DrugBank ID | DB08439 |
Pharmacology
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Lactotransferrin | Humans |
ADME / PK
| Half-life | 22 minutes (parecoxib); 8 hours (valdecoxib) |
|---|---|
| Protein binding | 98% |
| Metabolism | Hepatic. Metabolized primarily via CYP3A4 and 2C9 to valdecoxib and propionic acid. |
Formulation & handling
- Parecoxib is a small molecule formulated primarily for parenteral administration via intramuscular or intravenous injection.
- The compound exhibits low water solubility, necessitating formulation as a lyophilized powder for reconstitution before use.
- Stability considerations include protecting the lyophilized powder from moisture to maintain potency prior to reconstitution.
Regulatory status
| Lifecycle | The API has passed patent expiration in both the EU and US, with multiple generic products available, indicating a mature market phase in these regions. New product launches are primarily focused on formulations or combinations rather than novel exclusivity. |
|---|
| Markets | EU, US |
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Supply Chain
| Supply chain summary | The manufacturing landscape for parecoxib involves several originator companies producing branded formulations, primarily under the name Dynastat. These branded products have a significant presence in both EU and US markets. Patent expirations in key regions suggest the potential for existing or upcoming generic competition. |
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Parecoxib is a type of NSAIDs
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are a widely used subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs). These medications are commonly prescribed for their analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) properties. NSAIDs work by inhibiting the production of certain enzymes called cyclooxygenases (COX), which play a crucial role in the synthesis of prostaglandins, substances that contribute to pain, inflammation, and fever.
These pharmaceutical APIs are available in various formulations, including tablets, capsules, creams, and gels, making them convenient for different administration routes. Some popular examples of NSAIDs include aspirin, ibuprofen, naproxen, and diclofenac.
NSAIDs are commonly used to treat a wide range of conditions such as arthritis, musculoskeletal injuries, dental pain, menstrual pain, and headaches. They are also effective in managing inflammatory conditions like rheumatoid arthritis and ankylosing spondylitis.
While NSAIDs are generally safe and effective when used as directed, they may have side effects. These can include gastrointestinal issues such as stomach ulcers or bleeding, cardiovascular risks, and kidney problems. Therefore, it is essential to follow the recommended dosage and consult with healthcare professionals to ensure proper and safe usage.
In conclusion, NSAIDs are a subcategory of pharmaceutical APIs that offer analgesic, anti-inflammatory, and antipyretic properties. Their versatility and effectiveness in treating various conditions make them widely prescribed medications. However, it is crucial to be aware of potential side effects and consult healthcare providers for appropriate usage.
Parecoxib (NSAIDs), classified under Anti-inflammatory Agents
Anti-inflammatory agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat various inflammatory conditions. These agents play a vital role in alleviating pain, reducing swelling, and controlling inflammation in the body. They are widely employed in the management of diverse medical conditions, including arthritis, autoimmune disorders, asthma, and skin conditions like dermatitis.
Anti-inflammatory APIs primarily function by inhibiting the production of specific enzymes called cyclooxygenases (COX) and lipoxygenases (LOX). These enzymes are responsible for the synthesis of pro-inflammatory molecules known as prostaglandins and leukotrienes, respectively. By suppressing the activity of COX and LOX, anti-inflammatory agents effectively curtail the production of these inflammatory mediators, thereby mitigating inflammation.
Common examples of anti-inflammatory APIs include non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, aspirin, and naproxen. These agents exhibit analgesic, antipyretic, and anti-inflammatory properties. Another group of anti-inflammatory APIs includes corticosteroids, such as prednisone and dexamethasone, which are synthetic hormones that modulate the body's immune response to control inflammation.
In conclusion, anti-inflammatory agents are a vital category of pharmaceutical APIs widely used to manage inflammation-related disorders. They target enzymes involved in the synthesis of pro-inflammatory molecules, effectively reducing pain and swelling. NSAIDs and corticosteroids are commonly prescribed anti-inflammatory APIs due to their efficacy in controlling inflammation.
Parecoxib API manufacturers & distributors
Compare qualified Parecoxib API suppliers worldwide. We currently have 5 companies offering Parecoxib API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 229 products |
| Lifecare Laboratories | Producer | India | India | CoA | 50 products |
| MSN Organics | Producer | India | India | CoA, USDMF | 21 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 762 products |
| Zhejiang Haisen Pharma | Producer | China | China | CoA, EDMF/ASMF | 7 products |
When sending a request, specify which Parecoxib API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Parecoxib API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
