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Suppliers and packagers for GEMFIBROZIL
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GEMFIBROZIL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ascent Pharms Inc | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 214603 | ANDA | Camber Pharmaceuticals, Inc. | 31722-128-05 | 500 TABLET in 1 BOTTLE (31722-128-05) | 2021-01-20 |
| Ascent Pharms Inc | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 214603 | ANDA | Camber Pharmaceuticals, Inc. | 31722-128-60 | 60 TABLET in 1 BOTTLE (31722-128-60) | 2021-01-20 |
| Ascent Pharms Inc | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 214603 | ANDA | A-S Medication Solutions | 50090-5808-0 | 60 TABLET in 1 BOTTLE (50090-5808-0) | 2021-01-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Gemfibrozil
Introduction
Gemfibrozil is a widely prescribed lipid-lowering agent classified as a fibrate. It is primarily used to treat hypertriglyceridemia and certain forms of dyslipidemia, reducing the risk of pancreatitis and cardiovascular events associated with elevated triglyceride levels. The global supply chain for gemfibrozil involves multiple suppliers, including active pharmaceutical ingredient (API) manufacturers, formulators, and distributors. This article provides a comprehensive overview of the leading suppliers, their geographic distribution, manufacturing capabilities, and market dynamics, enabling stakeholders to navigate the complex landscape of gemfibrozil procurement effectively.
Market Overview of Gemfibrozil Supply
The demand for gemfibrozil has historically been steady due to its longstanding role in lipid management. Despite the emergence of novel lipid-lowering agents like PCSK9 inhibitors, gemfibrozil remains relevant, especially in regions with limited access to newer therapies. The supply chain involves several stages:
- API Manufacturing: Core suppliers produce the active pharmaceutical ingredient.
- Formulation: Companies incorporate API into finished dosage forms.
- Distribution: Wholesalers and direct channels distribute to healthcare providers and pharmacies.
Key regions contributing to supply include India, China, the European Union, and North America. Among these, India and China are prominent due to their extensive generic manufacturing capacity.
Major Suppliers of Gemfibrozil API
1. Zhuhai Ankang Pharmaceutical Co., Ltd. (China)
Zhuhai Ankang stands out as a significant Chinese API producer for gemfibrozil. The company boasts a robust manufacturing facility with Good Manufacturing Practice (GMP) certifications. Their API quality complies with international standards, serving both domestic and export markets.
2. Hubei Quanyang Pharmaceutical Co., Ltd. (China)
Specializing in lipid-modulating agents, Hubei Quanyang supplies high-purity gemfibrozil API. The company emphasizes quality assurance, ensuring its products align with pharmacopoeial standards, appealing to global clients.
3. Dr. Reddy’s Laboratories (India)
A globally recognized pharmaceutical company, Dr. Reddy’s manufactures gemfibrozil API as part of its extensive generics portfolio. Their APIs are supplied to various markets, including North America and Europe, adhering to strict regulatory standards.
4. Aurobindo Pharma (India)
Aurobindo is another prominent Indian API manufacturer involved in gemfibrozil production. Their manufacturing facilities are GMP-certified, and they serve both domestic and international markets, often competitively priced.
5. Zhejiang Remeike Biotechnology Co., Ltd. (China)
Specializing in lipid-lowering APIs, Zhejiang Remeike offers gemfibrozil with a focus on quality and cost efficiency. Their strategic investments in R&D enable continuous improvement of their API processes.
Formulation and Finished Dosage Product Suppliers
Beyond API suppliers, several pharmaceutical companies formulate and market gemfibrozil as a finished medication:
- Teva Pharmaceuticals (Israel): Markets gemfibrozil in various formulations primarily for North American and European markets.
- Mylan (U.S.): Distributes gemfibrozil generics globally, utilizing robust supply chains.
- Sun Pharmaceutical Industries (India): Offers gemfibrozil tablets globally, leveraging Indian manufacturing strength.
- Sandoz (Switzerland): Supplies generic gemfibrozil products across multiple regions.
These firms typically source active ingredients from API manufacturers and focus on quality control, regulatory approvals, and distribution networks.
Emerging Suppliers and Market Dynamics
The gemfibrozil supply chain is evolving amid changing regulatory landscapes, market competition, and geopolitical factors. Notably:
- Chinese API producers are expanding capacity to meet growing demand, with investments in advanced synthesis technologies allowing for higher purity levels.
- Indian APIs benefit from the country's robust pharmaceutical manufacturing infrastructure, often offering competitive prices with high compliance standards.
- Regulatory challenges in North America and Europe influence sourcing decisions, prompting companies to audit suppliers rigorously and seek ISO and GMP certifications.
- Supply disruptions have occasionally occurred, accentuated by factors like the COVID-19 pandemic, highlighting the need for diversified sourcing strategies.
Regulatory and Quality Considerations
For procurement, ensuring APIs and finished products adhere to relevant standards such as USP, EP, or JP is critical. Suppliers with GC (GMP) certification and transparent quality documentation are preferred. Regulatory compliance impacts market access, with agencies like the FDA and EMA scrutinizing manufacturing sites and processes.
Pricing and Contracting Trends
Pricing for gemfibrozil API varies based on quantity, certification, and geopolitical factors. Bulk purchasing from reliable, certified suppliers can result in cost efficiencies. Long-term contracts and supplier qualification processes are common for large purchasers to mitigate risks such as supply interruptions and regulatory non-compliance.
Challenges in the Gemfibrozil Supply Chain
- Quality assurance: Variability in API purity can impact clinical efficacy and safety.
- Regulatory hurdles: Differing regional standards may complicate import/export logistics.
- Supply security: Dependence on limited suppliers or regions poses risks during disruptions.
- Environmental and sustainability concerns: Increasingly, manufacturers face pressure to demonstrate sustainable practices.
Conclusion: Navigating the Gemfibrozil Supply Landscape
The supply of gemfibrozil, while historically stable, requires strategic sourcing, diligent quality assurance, and regulatory compliance. Leading suppliers from China and India dominate the API landscape, supported by a network of formulators and distributors across the globe. As the market shifts, stakeholders should prioritize diversification, rigorous supplier qualification, and adherence to evolving quality standards to ensure uninterrupted access to this essential medication.
Key Takeaways
- The primary API suppliers for gemfibrozil are concentrated in China and India, with companies like Zhuhai Ankang, Hubei Quanyang, Dr. Reddy’s, and Aurobindo leading the market.
- Ensuring regulatory compliance, GMP certification, and high API purity levels are essential in supplier selection.
- Market dynamics are influenced by geopolitical tensions, regulatory changes, and global supply chain disruptions.
- Formulation companies like Teva, Mylan, and Sun Pharma play critical roles in bringing gemfibrozil to market.
- Diversification and rigorous supplier validation are strategic imperatives to mitigate risks associated with supply interruptions.
FAQs
1. Who are the top global suppliers of gemfibrozil API?
The leading API suppliers are primarily located in China (Zhuhai Ankang, Hubei Quanyang) and India (Dr. Reddy’s, Aurobindo), with some European and North American firms also involved in formulation and distribution.
2. What quality standards should I look for in gemfibrozil API suppliers?
Suppliers should demonstrate GMP certification, adherence to USP, EP, or JP standards, and transparent quality documentation, including recent batch testing reports.
3. How does geopolitical tension impact gemfibrozil supply?
Trade restrictions, tariffs, and regional regulations can affect API availability, emphasizing the need for diversified sourcing and supply chain resilience.
4. Are there significant regional differences in gemfibrozil pricing?
Yes. Cost differences are influenced by manufacturing scale, regulatory requirements, and regional economic factors, with Indian and Chinese suppliers often offering lower prices.
5. What are future trends in the gemfibrozil supply chain?
Improvements in manufacturing technologies, enhanced quality control, and increased focus on sustainability are shaping the future, alongside efforts to diversify supply sources to reduce disruption risks.
Sources
[1] Pharmaceutical Substances Market Reports, GlobalData, 2022.
[2] WHO Gazetteer on API Manufacturers, 2023.
[3] US FDA Drug Master Files (DMFs), 2022.
[4] Industry analysis reports from IQVIA and Frost & Sullivan, 2022.
[5] Company websites and annual reports of leading manufacturers.
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