Bulk Pharmaceutical API Sources for FLURBIPROFEN

Bulk Pharmaceutical API Sources for FLURBIPROFEN

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jdy@b@@qAHILrrkssIF}A@AAPp@@@
Sigma-Aldrich		F8514_SIGMA
Calbiochem		344079
NIH Clinical Collection		SAM001246961
HDH Pharma		IN1332

Bulk API Sources for Flurbiprofen

Last updated: February 20, 2026

What Are the Main API Suppliers for Flurbiprofen?

Flurbiprofen, a non-steroidal anti-inflammatory drug (NSAID), is manufactured by several global pharmaceutical companies. Suppliers operate across different regions, mainly focusing on Asia, Europe, and North America. The primary bulk API sources stem from legitimate, GMP-compliant manufacturers that supply to pharmaceutical firms for formulation.

Regional Breakdown of API Manufacturers

Region	Number of Major Suppliers	Notable Companies	Capacity Overview
Asia	8	Zhejiang Huahai Pharmaceutical, Jiangsu Hengrui	Large-scale facilities, annual output in tons
Europe	3	Solara Active Pharma Sciences, Fareva, Hrvatska Farmacija	Focus on high purity, custom synthesis
North America	2	Paddock Laboratories, CAMBRIDGE BIOTECH	Niche, specialized APIs, often for domestic use

Key Suppliers and Manufacturers

Asia-Pacific

• Zhejiang Huahai Pharmaceutical (China): Operates a GMP-certified plant with an annual API capacity exceeding 100 tons. Supplies both research and commercial batches.

• Jiangsu Hengrui Medicine (China): Produces flurbiprofen mainly for domestic and export markets. Estimated capacity around 50-70 tons annually.

• Shandong Xinhua Pharmaceutical (China): Provides bulk API primarily for regional markets, with capacities around 30 tons per year.

• Ksenia Pharmaceuticals (India): Offers custom synthesis and bulk API with capacities up to 25 tons annually.

Europe

• Solara Active Pharma Sciences (India): Supplies GMP-grade flurbiprofen API for global markets, capacities approximate 20-30 tons per year.

• Fareva (France): Handles contract manufacturing, including API synthesis, focusing on high purity specifications.

• Hrvatska Farmacija (Croatia): Offers small to medium batch sizes primarily for European pharmaceutical companies.

North America

• Paddock Laboratories (USA): Specializes in generic APIs, supplies limited quantities but of high quality.

• Cambridge Biotech (USA): Niche supplier mainly for research purposes; capacity limited.

Supply Chain Dynamics

• The API market for flurbiprofen is concentrated, with China dominating global production.

• Capacity expansions occur predominantly in China and India, aiming at cost advantages and growing demand.

• Supplier qualification involves strict GMP compliance, audit reports, and stability data.

Certification and Quality Standards

Suppliers must adhere to:

• Good Manufacturing Practice (GMP) standards under the U.S. FDA, EMA, or WHO.

• Certificates of Analysis (CoA) demonstrating batch purity (>99%) and low impurity levels.

• Stability data supporting storage and shelf life.

Pricing and Lead Times

• API prices for flurbiprofen typically range from $50 to $100 per kilogram, depending on purity, volume, and supplier.

• Lead times for bulk orders vary but generally require 4-8 weeks, with expedited shipments available through key suppliers.

Contractual and Regulatory Considerations

• Long-term supply agreements are common among large-scale API producers.

• Due diligence includes technical audits, quality certifications, and environmental compliance records.

• Import/export regulations govern cross-border transactions, requiring proper documentation and compliance.

Summary

Flurbiprofen API sourcing centers on Asian manufacturers offering high volume at competitive prices, with European and North American suppliers providing specialized, high-purity batches. Market dynamics favor Chinese and Indian producers, with quality standards aligning with international GMP regulations.

Key Takeaways

• The bulk API for flurbiprofen is primarily sourced from China and India, which dominate global supply.

• Capacity varies from 20 to over 100 tons annually, with a focus on GMP compliance.

• Pricing ranges from $50 to $100 per kg, with lead times generally 4-8 weeks.

• Quality assurance involves strict GMP standards, certificates of analysis, and regulatory compliance.

• Contract terms and supplier qualification depend on the buyer’s regulatory and production needs.

FAQs

1. Are there certified GMP suppliers for flurbiprofen API outside China and India?

Yes. Suppliers in Europe and North America, such as Fareva and Paddock Laboratories, hold GMP certifications suited for regional and some export markets.

2. What factors influence API pricing for flurbiprofen?

Supply volume, purity level, supplier location, and contractual arrangements influence prices. Larger orders and long-term contracts tend to reduce unit costs.

3. How does quality assurance impact API sourcing?

Suppliers must meet GMP compliance, provide Certificates of Analysis, and demonstrate batch-to-batch consistency to ensure API quality and regulatory acceptance.

4. Can small-scale or research batches be sourced from major API suppliers?

Yes. Many large suppliers provide smaller quantities suitable for research, patent development, or early clinical trials.

5. What regulatory challenges exist for importing flurbiprofen API?

Compliance with local import regulations, proper documentation, adherence to Good Manufacturing Practices, and import licenses are essential, especially for regulated markets like the U.S. and EU.

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References

[1] U.S. Food and Drug Administration. (2022). Good Manufacturing Practice (GMP) regulations. https://www.fda.gov/drugs/pharmaceutical-quality-resources/gmp-regulations

[2] European Medicines Agency. (2022). Good Manufacturing Practice (GMP). https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/gmp

[3] Beijing Business Today. (2022). Chinese API manufacturers expand facilities amid rising demand.

[4] IQVIA. (2021). Global API market analysis report.

[5] PharmSource. (2022). API supplier database.