Bulk Pharmaceutical API Sources for TEGISON

Bulk Pharmaceutical API Sources for TEGISON

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-6823
Molport		MolPort-005-937-301
Amadis Chemical		A830117
AKos Consulting & Solutions		AKOS015889992
Finetech Industry Limited		FT-0653621

Bulk Active Pharmaceutical Ingredient (API) Sources for TEGISON

Last updated: July 30, 2025

Introduction

TEGISON, with the generic name piroxicam, is a non-steroidal anti-inflammatory drug (NSAID) widely used to treat osteoarthritis, rheumatoid arthritis, and other musculoskeletal disorders. The efficacy and safety of TEGISON rely heavily on the quality of its active pharmaceutical ingredient (API). Ensuring a reliable supply chain for high-quality piroxicam API is crucial for pharmaceutical manufacturers, distributors, and regulators. This report provides an in-depth overview of bulk API sources for TEGISON, highlighting key manufacturers, sourcing considerations, quality standards, and market dynamics.

Understanding the Market for Piroxicam API

The global API market, especially for NSAIDs like piroxicam, is characterized by a limited number of specialized producers. Major API manufacturers tend to operate under rigorous quality controls aligned with international standards such as the US FDA, EMA, and WHO guidelines. The demand for piroxicam API is driven by the global prevalence of arthritis and other chronic inflammatory conditions, especially in aging populations, ensuring steady procurement needs from pharmaceutical firms.

Major API Manufacturers for Piroxicam

1. Sun Pharmaceutical Industries Ltd. (India)
   As one of the world's largest generic drug manufacturers, Sun Pharma produces piroxicam API complying with global standards. Their API facilities are certified by major regulatory bodies, ensuring quality, consistency, and reliable supply.

2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
   A leading Chinese API manufacturer, Hisun supplies piroxicam API to multiple markets including North America and Europe. Their production adheres to GMP standards, with robust quality assurance frameworks.

3. Aurobindo Pharma (India)
   Known for competitive pricing and high-quality API production, Aurobindo's piroxicam API is widely used by generic drug companies worldwide. They have dedicated R&D and manufacturing facilities adhering to WHO GMP certification.

4. Mitra Pharma (India)
   Mitra Pharma provides bulk piroxicam API primarily for regional markets. Their production facilities undergo rigorous quality testing, with an emphasis on regulatory compliance.

5. Hetero Drugs Ltd. (India)
   Hetero manufactures piroxicam API, emphasizing high purity and batch-to-batch consistency. Their manufacturing plants meet international quality standards, facilitating global exports.

6. Xinhua Pharmaceutical Co., Ltd. (China)
   Xinhua is a significant producer of NSAIDs, including piroxicam API, focusing on quality control that meets GMP and international standards.

7. Corden Pharma (Germany)
   Though primarily a specialty API producer, Corden Pharma supplies high-purity piroxicam APIs suitable for parenteral and injectable formulations, emphasizing stringent quality controls.

Sources and Supply Chain Considerations

• Geographical Distribution: Predominantly, Indian and Chinese pharmaceutical companies dominate the production of piroxicam API, due to cost advantages and established manufacturing expertise [1].

• Regulatory Compliance: Sourcing from manufacturers with GMP certification and WHO approval ensures the API meets standards for quality, safety, and efficacy.

• Pricing and Lead Times: Indian manufacturers typically offer competitive pricing with reliable lead times. Chinese suppliers may offer short-term cost benefits but warrant careful auditing for compliance.

• Quality Assurance: Suppliers providing detailed Certificates of Analysis (COA), stability data, and batch documentation are preferred. Regular audits and third-party testing enhance sourcing confidence.

Quality Standards and Certification

For pharmaceutical companies, API quality is non-negotiable. The following standards are essential:

• GMP Compliance: Ensures manufacturing processes meet internationally recognized good manufacturing practices.

• Pharmacopoeial Specifications: API should conform to pharmacopoeial monographs, such as USP, EP, or JP standards. For piroxicam, specifications include assays for purity, residual solvents, heavy metals, and microbiological purity.

• Regulatory Approvals: Suppliers with prior approval from regulatory agencies or who have undergone vendor qualification audits are preferable.

Current Trends and Market Dynamics

The API market's evolution for piroxicam reflects broader industry trends:

• Increased Quality Regulations: Stringent regulations by agencies like the FDA and EMA have prompted manufacturers to upgrade facilities and quality systems.

• Supply Chain Resilience: The COVID-19 pandemic exposed vulnerabilities in global supply chains, prompting companies to diversify sources and stockpile APIs.

• Emerging Markets: Growing demand in Asia and Latin America for affordable generics expands the potential supplier pool.

• Environmental and Sustainability Practices: Sustainability initiatives influence sourcing decisions, favoring manufacturers with environmentally friendly manufacturing protocols.

Supply Chain Challenges

• Regulatory Divergence: Differing regional standards necessitate thorough qualification processes.

• Intellectual Property Risks: Although piroxicam's patents have expired, counterfeit or substandard APIs pose a risk in unregulated markets.

• Volatile Raw Material Prices: Fluctuations impact API manufacturing costs, affecting supply stability.

Conclusion

The landscape of bulk API sourcing for TEGISON’s active ingredient, piroxicam, is dominated by a handful of global and regional manufacturers primarily located in India and China. Pharmaceutical companies aiming to procure high-quality piroxicam API should prioritize suppliers with strong regulatory certifications, transparent quality documentation, and proven manufacturing capabilities. Establishing long-term partnerships with trusted API producers enhances supply chain resilience and product quality assurance.

Key Takeaways

• The principal global API suppliers for piroxicam are Indian and Chinese manufacturers with extensive regulatory compliance credentials.

• Quality assurance, including GMP certification and pharmacopoeial adherence, is critical when selecting API sources.

• Diversification of suppliers mitigates geopolitical and regulatory risks and enhances supply reliability.

• Understanding regional market dynamics and regulatory landscapes informs better procurement decisions.

• Sustainability and environmental compliance are emerging as influencing factors in API sourcing.

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FAQs

Q1. What are the primary regions for sourcing API for TEGISON?
Most piroxicam API is sourced from India and China, owing to their large-scale manufacturing capacities, cost advantages, and compliance with international standards.

Q2. How can I verify the quality of an API supplier?
Verify the supplier’s GMP and regulatory certifications, review Certificates of Analysis, conduct supplier audits, and seek third-party testing reports to ensure product quality and compliance.

Q3. Are there differences between API grades in the market?
Yes. API grades vary from pharmaceutical grade (meeting strict pharmacopoeial and regulatory standards) to technical grade, which may have higher impurity levels unsuitable for human consumption.

Q4. How does regulatory compliance influence API sourcing?
Regulatory compliance ensures the API conforms to safety, effectiveness, and quality standards demanded by health authorities, minimizing the risk of product recalls or regulatory penalties.

Q5. What are the emerging trends impacting API sourcing for NSAIDs like piroxicam?
Recent trends include increased regulatory scrutiny, supply chain diversification, emphasis on environmentally sustainable manufacturing, and digital tracking for supply chain transparency.

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References

1. Statista. (2022). Global Active Pharmaceutical Ingredient Market Size and Forecast.
2. U.S. Pharmacopeia. (2021). General Chapters on Pharmaceutical Ingredients.
3. WHO Good Manufacturing Practices (GMP) Certification Database. (2022).
4. Pharma Intelligence. (2022). Global API Market Reports.
5. Industry reports on NSAID API manufacturing and market dynamics (various).