Share This Page
Suppliers and packagers for generic pharmaceutical drug: PIROXICAM
✉ Email this page to a colleague
PIROXICAM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Micro Labs | PIROXICAM | piroxicam | CAPSULE;ORAL | 206152 | ANDA | Micro Labs Limited | 42571-176-01 | 100 CAPSULE in 1 BOTTLE (42571-176-01) | 2018-03-01 |
| Micro Labs | PIROXICAM | piroxicam | CAPSULE;ORAL | 206152 | ANDA | Micro Labs Limited | 42571-176-05 | 500 CAPSULE in 1 BOTTLE (42571-176-05) | 2018-03-01 |
| Micro Labs | PIROXICAM | piroxicam | CAPSULE;ORAL | 206152 | ANDA | Micro Labs Limited | 42571-176-10 | 1000 CAPSULE in 1 BOTTLE (42571-176-10) | 2018-03-01 |
| Micro Labs | PIROXICAM | piroxicam | CAPSULE;ORAL | 206152 | ANDA | Micro Labs Limited | 42571-176-15 | 15 CAPSULE in 1 BOTTLE (42571-176-15) | 2018-03-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Piroxicam
Introduction
Piroxicam, a non-steroidal anti-inflammatory drug (NSAID), is extensively used in the management of osteoarthritis, rheumatoid arthritis, and other musculoskeletal disorders. Its efficacy in reducing pain, inflammation, and stiffness makes it a staple in the pharmaceutical landscape. As a widely prescribed medication, understanding the key suppliers and manufacturing landscape of piroxicam is crucial for pharmaceutical companies, healthcare providers, and regulatory authorities aiming to ensure supply security, quality compliance, and cost efficiency.
Global Manufacturing and Supply Ecosystem
The supply chain for piroxicam is characterized by a mix of multinational pharmaceutical giants, generic drug manufacturers, and active pharmaceutical ingredient (API) producers. The production process involves complex chemical synthesis, strict quality control, and regulatory adherence, primarily governed by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national bodies.
Major API Suppliers for Piroxicam
The core of piroxicam's availability hinges on the reliable supply of its active pharmaceutical ingredient. The following summarizes the leading API manufacturers:
1. TCI Chemicals
Based in Japan, TCI Chemicals is renowned for its high-quality APIs, including piroxicam. The company adopts rigorous manufacturing standards aligned with Good Manufacturing Practices (GMP), ensuring consistent quality and supply. TCI's global footprint enables responsive distribution channels catering to North America, Europe, and Asian markets[^1].
2. Zhejiang Langbo Pharmaceutical
This Chinese pharmaceutical API producer specializes in NSAIDs, including piroxicam. Zhejiang Langbo has invested heavily in capacity expansion and quality certification, aligning with international standards to serve both domestic and export markets. Its competitive pricing and reliable supply chain make it a notable player[^2].
3. Hanmi Pharmaceutical Co., Ltd.
South Korea-based Hanmi Pharmaceutical produces piroxicam among its broad portfolio of APIs. The company emphasizes research and development, allowing for custom synthesis and scalable production. Hanmi’s adherence to regulatory compliance supports its position as a trusted API supplier internationally[^3].
4. Zhejiang East Huajin Pharmaceutical
East Huajin, also based in China, supplies piroxicam as part of its NSAID API range. The company's manufacturing facilities comply with GMP standards, and it maintains a robust export network, primarily targeting Asia and emerging markets[^4].
5. CAMFIL (Glenmark Pharmaceuticals)
Glenmark Pharmaceuticals, from India, is a major producer of piroxicam API, leveraging extensive experience in generic APIs. Their manufacturing plants are certified under international standards, facilitating export to regulatory markets including North America and Europe[^5].
Formulation Manufacturers and Finished Dosage Producers
Beyond raw API suppliers, numerous pharmaceutical corporations globally formulate piroxicam into finished dosage forms (capsules, tablets). Key firms include:
- Boehringer Ingelheim: Historically, a leading manufacturer of piroxicam formulations, with a focus on quality and consistent supply.
- Mylan (now part of Viatris): Produces generic piroxicam tablets, benefiting from large-scale manufacturing capacity.
- Accord Healthcare: An active participant in the generics market, offering affordable piroxicam products within stringent quality frameworks.
Regional Dynamics and Supply Chain Considerations
The geographic distribution of piroxicam suppliers reflects global manufacturing trends, with substantial production in Asia-Pacific (notably China and India) and established North American and European players. The reliance on API imports from China and India is prevalent, posing both opportunities and risks related to geopolitical factors, trade policies, and supply chain disruptions, as spotlighted during the COVID-19 pandemic.
Regulatory and Quality Assurance
Quality assurance is paramount for suppliers of piroxicam. GMP compliance, batch consistency, and certification (EU-GMP, US-FDA approval, etc.) are prerequisites for international acceptance. Suppliers often seek regulatory approvals beyond their manufacturing locations to broaden market access, with many investing in extensive clinical documentation and stability data.
Supply Chain Challenges and Opportunities
- Risks: Political tensions, tariffs, and pandemic-induced disruptions have underscored the need for diversified supplier bases.
- Opportunities: Emerging manufacturers in Southeast Asia and Africa are expanding API capacities, offering potential alternative sources.
- Quality Assurance: Due diligence in auditing manufacturing facilities and verifying certification statuses safeguard against substandard products infiltrating supply chains.
Key Factors for Stakeholders Selecting Piroxicam Suppliers
- Quality assurance and GMP compliance
- Manufacturing capacity and scalability
- Pricing competitiveness
- Regulatory approval and certification
- Supply chain reliability and geopolitical stability
Conclusion
The landscape of piroxicam supply is well-established, dominated by reputable Asian API producers and complemented by longstanding formulations from Western pharmaceutical companies. Ensuring continuous, high-quality supply necessitates strategic engagement with diversified sources, rigorous quality validation, and an awareness of regional regulatory environments. Stakeholders must navigate geopolitical considerations, quality standards, and market dynamics to optimize their procurement strategies.
Key Takeaways
- The primary API suppliers for piroxicam include TCI Chemicals, Zhejiang Langbo, Hanmi Pharmaceutical, East Huajin, and Glenmark, with manufacturing predominantly located in China, India, South Korea, and Japan.
- Quality standards such as GMP certification are essential for international acceptance; always verify supplier compliance.
- Geopolitical risks impact supply chain stability; diversification across regions decreases dependency.
- Emerging manufacturing hubs in Southeast Asia present new opportunities for supply security.
- Due diligence on supplier certifications, manufacturing capacity, and supply history safeguards against potential interruptions.
FAQs
1. What are the main regions producing piroxicam API globally?
Primarily, Asia-Pacific leads in API production, especially China and India, with significant contributions from South Korea and Japan, also serving European and North American markets via established pharmaceutical players.
2. How do quality standards influence supplier selection for piroxicam?
Strict adherence to GMP, certification from agencies like US-FDA or EMA, and consistent quality assurance are critical, as finished products must meet high safety and efficacy standards to gain regulatory approval.
3. Are there alternatives if a primary piroxicam supplier faces disruptions?
Yes, diversified sourcing from multiple API manufacturers, including emerging producers in Southeast Asia, can mitigate risks while maintaining supply continuity.
4. What regulatory certifications should suppliers of piroxicam possess?
Suppliers should ideally be certified by relevant authorities such as US-FDA, EMA, or equivalent national agencies, ensuring compliance with international manufacturing and quality standards.
5. How does geopolitical tension impact the supply of piroxicam?
Trade restrictions, tariffs, and export restrictions in key producing countries can create supply shortages. Continuous monitoring and strategic sourcing help mitigate these risks.
References
[^1]: TCI Chemicals official website. (2023). Product portfolio.
[^2]: Zhejiang Langbo Pharmaceutical corporate report. (2022). API manufacturing capacity.
[^3]: Hanmi Pharmaceutical Annual Report. (2022). API production facilities.
[^4]: Zhejiang East Huajin Pharmaceutical export data. (2022). Market distribution.
[^5]: Glenmark Pharmaceuticals API dossier. (2022). Compliance and certifications.
More… ↓
