Anti-Inflammatory APIs
Premium Non-Steroidal Anti-Inflammatory Drug (NSAID) Active Pharmaceutical Ingredients
About Anti-Inflammatory APIs
Holiness Pharmaceutical specializes in manufacturing and exporting high-quality Anti-Inflammatory APIs, primarily Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) used for pain relief, fever reduction, and inflammation management. Our comprehensive portfolio includes selective and non-selective COX inhibitors manufactured under WHO-GMP standards, serving pharmaceutical companies worldwide in developing effective pain management and anti-inflammatory formulations.
Key Features
- WHO-GMP certified NSAID manufacturing facility
- Compliance with IP, BP, USP, and EP pharmacopeial standards
- Both COX-1 and COX-2 selective inhibitors available
- Multiple polymorphic forms with controlled specifications
- Advanced synthesis and purification processes
- Comprehensive genotoxic impurity control
- Complete analytical and regulatory documentation
- Particle size optimization for various dosage forms
Application Areas
Pain Management
Relief from acute and chronic pain including headaches, dental pain, and musculoskeletal pain
Arthritis Treatment
Management of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
Fever Reduction
Antipyretic action for reducing fever in various conditions
Post-operative Care
Pain and inflammation management following surgical procedures
Sports Injuries
Treatment of sprains, strains, and soft tissue injuries
Quality Assurance
Every batch of anti-inflammatory APIs undergoes rigorous testing including HPLC analysis for purity and related substances, polymorphic form characterization, particle size distribution analysis, residual solvent testing, genotoxic impurity screening, and comprehensive microbiological evaluation. Our quality systems ensure consistent pharmaceutical-grade products meeting international regulatory requirements.
Our Anti-Inflammatory APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Aceclofenac API | 89796-99-6 | IP/BP/EP /USP | API Powder | View Product |
Etodolac API | 41340-25-4 | IP/BP/EP/USP | API Powder | View Product |
Ibuprofen API | 15687-27-1 | IP/BP/USP | API Powder | View Product |
Meloxicam API | 71125-38-7 | IP/BP/USP | API Powder | View Product |
Nimesulide API | 51803-78-2 | IP/BP/USP | API Powder | View Product |
Frequently Asked Questions
What are Anti-Inflammatory APIs?
Anti-Inflammatory APIs are active pharmaceutical ingredients, primarily NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), that reduce inflammation, relieve pain, and lower fever by inhibiting cyclooxygenase (COX) enzymes. These include commonly used drugs like ibuprofen, diclofenac, aceclofenac, meloxicam, and nimesulide.
Which anti-inflammatory APIs does Holiness Pharmaceutical manufacture?
We manufacture a comprehensive range including Aceclofenac, Ibuprofen, Meloxicam, Nimesulide, Etodolac, Piroxicam, and related NSAIDs. All products meet IP, BP, USP, or EP pharmacopeial standards and are available in various specifications suitable for different formulation requirements.
What is the difference between COX-1 and COX-2 inhibitors?
COX-1 inhibitors are non-selective NSAIDs that block both COX-1 and COX-2 enzymes, providing anti-inflammatory effects but with potential gastrointestinal side effects. COX-2 selective inhibitors primarily target COX-2, offering similar anti-inflammatory benefits with reduced GI complications. We manufacture both types to meet different therapeutic needs.
How do you control polymorphic forms in NSAID APIs?
We maintain strict control over crystallization conditions including temperature, solvent selection, seeding, and cooling rates. Each batch is characterized using techniques like X-Ray Powder Diffraction (XRPD), Differential Scanning Calorimetry (DSC), and infrared spectroscopy to ensure the specified polymorphic form, which is crucial for dissolution and bioavailability.
What particle size options are available for anti-inflammatory APIs?
We offer various particle size distributions optimized for different dosage forms: micronized grades for tablets and capsules with improved dissolution, granular forms for direct compression, and fine powders for suspension formulations. Particle size specifications can be customized based on formulation requirements.
Do you test for genotoxic impurities in NSAID APIs?
Yes, we conduct comprehensive genotoxic impurity assessments in accordance with ICH M7 guidelines. Our analytical methods include sensitive techniques to detect and quantify potential genotoxic impurities below acceptable limits, ensuring patient safety and regulatory compliance.
Can you provide bioavailability enhancement support for poorly soluble NSAIDs?
Yes, our technical team provides support for improving bioavailability through particle size reduction, salt selection, solid dispersion technology guidance, and co-crystal formation recommendations. We can supply micronized grades and provide solubility data to support formulation development.
What is the typical lead time for anti-inflammatory API orders?
Lead times vary depending on the specific product and quantity. Standard products typically have 4-6 weeks lead time from order confirmation. We maintain strategic inventory of key NSAIDs to ensure timely supply. Custom specifications or new products may require 8-10 weeks including development and validation.