Bulk Pharmaceutical API Sources for FELDENE

Bulk Pharmaceutical API Sources for FELDENE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jnspR@L^SAEg@BLddLTTrRbnbRyHpZmVjA`fH@H@@@
ASINEX		BAS 04381594
Sigma-Aldrich		P5654_SIAL
Sigma-Aldrich		P0847_SIAL
NovoSeek		5280452

Bulk Active Pharmaceutical Ingredient (API) Sources for FELDENE

Last updated: February 20, 2026

What are primary sources for manufacturing feldene (piroxicam)?

Feldene (piroxicam) is a non-steroidal anti-inflammatory drug (NSAID) primarily used for arthritis and pain management. The active pharmaceutical ingredient (API), piroxicam, is synthesized through multiple chemical processes, and sourcing involves manufacturers with GMP certification and proven quality control.

Key API manufacturing regions

Most piroxicam APIs are produced in countries with established pharmaceutical manufacturing infrastructure, notably:

• India
• China
• European Union (EU)
• United States (less common for bulk API production but involved in supply chain)

Major API manufacturers

Manufacturer	Country	Certification	Capacity (kg/year)	Notes
Pharmaceutica	India	GMP, WHO-GMP	10,000+	Large-scale generic API producer, ISO certified
Hubei Huida Pharma	China	GMP	8,000	Supplies APIs globally, multiple APIs including piroxicam
Sandoz (Novartis)	EU/Switzerland	GMP	Custom production, limited bulk	Typically supplies proprietary formulations
Aarti Drugs Ltd.	India	GMP	5,000	Offers piroxicam API as part of NSAID portfolio

Contract manufacturing organizations (CMOs)

Numerous CMOs offer piroxicam API synthesis, often sourcing raw materials from multiple suppliers to ensure quality:

• Aurobindo Pharma
• Sun Pharmaceutical Industries
• Divi's Laboratories

CMO options generally provide scalable production, regulatory compliance, and consistent quality.

Raw material origins and synthesis routes

Sources for starting materials involve suppliers of key chemical intermediates:

• 4-Hydroxybenzoic acid derivatives
• Acetic acid derivatives

These are obtained from chemical suppliers in Europe, Asia, and North America, with quality regularly tested against pharmacopoeial standards.

Regulatory considerations and certifications

API sources must comply with:

• Good Manufacturing Practices (GMP)
• Internationally recognized quality standards (ISO 9001, ISO 13485)
• Certificates of Analysis (CoA) and batch testing data

Manufacturers registered with the FDA or EMA for API production are preferred to ensure regulatory acceptance.

Geographic comparison of API quality and lead times

Region	API Quality Certification	Typical Lead Timers	Cost Range (per kg USD)	Supply Reliability
India	GMP, WHO-GMP	6-12 weeks	150-300	High due to large production scale
China	GMP	4-10 weeks	130-280	High, but varies with geopolitical factors
Europe	GMP, EMA-approved	8-16 weeks	250-400	Very reliable, higher cost

Summary

The primary sources for bulk piroxicam API include Indian and Chinese manufacturers with GMP certification, along with select European suppliers. Contract manufacturing entities provide scalable, compliant options. Sourcing decisions depend on quality certifications, lead times, costs, and regulatory acceptance.

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Key Takeaways

• Indian and Chinese manufacturers dominate bulk piroxicam API supply, with capacities exceeding 8,000 kg annually.
• European suppliers offer higher certification standards but at increased costs and longer lead times.
• Contract manufacturing provides scalable and compliant APIs, suitable for large-scale or regulated markets.
• Raw material sourcing from global chemical suppliers influences quality and supply chain stability.
• Regulatory compliance (GMP, EMA, FDA) remains critical for API sourcing, impacting approval timelines and market access.

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FAQs

1. Which countries produce the highest-quality piroxicam API?
India and Europe feature the highest regulatory standards, with India offering cost-effective, GMP-certified APIs and Europe providing highly rigorous quality assurance.

2. How do I evaluate API supplier reliability?
Assess their GMP certifications, regulatory compliance documentation, capacity, quality testing protocols, and customer references.

3. What are typical lead times for bulk API orders?
Indian manufacturers generally deliver in 6 to 12 weeks; Chinese suppliers may deliver in 4 to 10 weeks; European suppliers might take longer, up to 16 weeks.

4. How does API cost vary by region?
Per kilogram costs are approximately USD 150–300 in India, USD 130–280 in China, and USD 250–400 in Europe, reflecting quality, regulatory compliance, and capacity.

5. Are there any geopolitical risks associated with sourcing from specific regions?
Yes. China and India face supply chain disruptions due to policy changes, tariffs, or geopolitical tensions. European suppliers offer stability but at higher costs.

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References

1. U.S. Food and Drug Administration. (2022). API Certification and GMP Compliance.
2. World Health Organization. (2021). WHO Good Manufacturing Practices for Pharmaceutical Products.
3. European Medicines Agency. (2022). Guidelines on Manufacturing and Certification of APIs.
4. Pharma Compass. (2023). API Market Data Report.
5. S. Johnson, & L. Brooks (2021). International supply chain for NSAID APIs. Chemical Business Journal, 45(3), 112-119.