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Suppliers and packagers for generic pharmaceutical drug: cefdinir
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cefdinir
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lupin | CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 065259 | ANDA | A-S Medication Solutions | 50090-3723-0 | 100 mL in 1 BOTTLE (50090-3723-0) | 2007-05-07 |
| Lupin | CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 065259 | ANDA | A-S Medication Solutions | 50090-6171-0 | 60 mL in 1 BOTTLE (50090-6171-0) | 2007-05-07 |
| Lupin | CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 065259 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3403-1 | 100 mL in 1 BOTTLE (68071-3403-1) | 2007-05-07 |
| Lupin | CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 065259 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3609-6 | 60 mL in 1 BOTTLE (68071-3609-6) | 2006-05-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cefdinir
Introduction
Cefdinir, a third-generation cephalosporin antibiotic, is widely prescribed for bacterial infections such as respiratory tract infections, sinusitis, and skin infections. Its global demand necessitates a complex and diverse supply chain, comprising a myriad of suppliers involved in raw material manufacturing, active pharmaceutical ingredients (API), excipients, formulation, and packaging. Ensuring a consistent and compliant supply of cefdinir hinges upon understanding its key suppliers, their geographic distribution, regulatory rigor, and capacity.
This analysis synthesizes current market insights, focusing on primary API producers, intermediaries, and formulation manufacturers, essential for stakeholders seeking to secure reliable cefdinir sourcing avenues.
Key Suppliers in the Cefdinir Supply Chain
1. API Manufacturers
The active pharmaceutical ingredient (API) constitutes the core of cefdinir’s therapeutic efficacy. Several multinational and regional manufacturers dominate this segment.
-
Macleods Pharmaceuticals (India):
As one of the largest API producers in India, Macleods supplies cefdinir API for domestic and international markets. The company operates FDA and international quality certifications, underscoring its compliance and capacity (source: company website[1]). -
Aurobindo Pharma (India):
Aurobindo’s API segment produces a range of antibiotics, including cefdinir, leveraging advanced synthesis processes. Their facilities meet global standards such as WHO-GMP, USFDA, and European EMA regulations (source: Aurobindo annual report[2]). -
Shandong Yuxin Bio-Tech (China):
A notable Chinese supplier, Yuxin supplies cefdinir API mainly to Asian markets. Their manufacturing facilities comply with China Food and Drug Administration (CFDA) standards and hold ISO certifications (source: company registry). -
Hetero Labs (India):
With extensive API manufacturing capacity, Hetero supplies cefdinir API achieved through robust R&D and quality control measures, fitting global quality compliance benchmarks (source: Hetero Pharma overview).
2. Generic API Suppliers
Additional suppliers are emerging from countries such as South Korea, Vietnam, and Brazil, expanding the global API landscape.
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Daewoong Pharmaceutical (South Korea):
Focused on high-quality antibiotics, Daewoong exports cefdinir API to various markets, aligned with strict international standards. -
Zhejiang Hisun Pharmaceutical (China):
Known for large-scale API production, Hisun supplies cefdinir API, emphasizing cost competitiveness and quality.
3. Contract Manufacturing Organizations (CMOs)
Manufacturers who produce cefdinir API on behalf of brand and generic companies include capabilities spanning from synthesis to processing.
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Boehringer Ingelheim (Germany):
Although primarily a pharmaceutical innovator, BI operates CMOs producing cefdinir APIs under global quality parameters. -
Sino Biopharmaceutical (Hong Kong):
Provides contract manufacturing for antibiotics including cefdinir, emphasizing quality and scalability.
4. Excipients and Formulation Components
Apart from APIs, suppliers of excipients must meet the strict standards applicable to antibiotic formulations.
- Dow Chemical & BASF:
Leading international excipient suppliers, providing stabilizers, fillers, and binders compatible with cefdinir formulations, compliant with pharmacopeial standards.
Regional Dynamics and Regulatory Considerations
The procurement of cefdinir involves navigating regulatory landscapes and regional supplier strengths:
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India:
Dominant in API supply, driven by cost-effective manufacturing, with companies holding USFDA, WHO-GMP, and UKMHRA approvals. -
China:
Major supplier of APIs, with increasing compliance to global standards, though regulatory transparency varies. -
Europe & North America:
Fewer API suppliers due to stricter regulatory hurdles but dominate in formulations and final product distribution.
Regulatory oversight influences supplier selection, as sourcing from certified entities reduces compliance risks. Stakeholders should verify certifications via databases such as the U.S. FDA’s ORANGE Book or the European Medicines Agency (EMA).
Supply Chain Challenges and Risks
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Quality Variability:
Variations across regions necessitate thorough qualification processes. Regular audits and certification verification are critical. -
Regulatory Compliance:
Suppliers lacking current GMP, WHO-GMP, or FDA certifications pose risks of non-compliance, market restrictions, or product recalls. -
Market Dynamics:
Capacity constraints amid global demand spikes due to health crises may affect supply stability. -
Tariff & Trade Policies:
US-China trade tensions and tariff policies can impact sourcing costs and timelines.
Strategic Sourcing Recommendations
-
Multiple Supplier Qualification:
Establish relationships with diversified API producers to mitigate risks associated with supply disruptions. -
Quality Assurance & Audits:
Conduct comprehensive supplier audits, focusing on manufacturing practices, QC processes, and compliance certifications. -
Long-term Contracting:
Secure supply stability through negotiated agreements, especially with high-volume API manufacturers. -
Monitoring Regulatory Changes:
Regularly track global regulatory updates affecting supplier eligibility and product approval status.
Conclusion
The global cefdinir supply landscape is predominantly characterized by Indian, Chinese, and regional API producers, complemented by contract manufacturers and excipient suppliers meeting rigorous quality standards. As demand increases, especially in emerging markets, stakeholders should emphasize qualification, diversification, and compliance to ensure consistent supply and regulatory adherence.
Key Takeaways
- India leads as the primary API source for cefdinir, with major players such as Macleods, Aurobindo, and Hetero ensuring regional and global coverage.
- China remains a significant API manufacturer, bolstered by increasing regulatory compliance.
- European and North American markets rely more on formulations and final product assembly, emphasizing the importance of supplier certifications.
- Ensuring supplier qualification, quality audits, and regulatory compliance mitigates supply chain risks.
- Diversification across regions and manufacturers enhances resilience amid geopolitical and market pressures.
Frequently Asked Questions (FAQs)
1. What are the main regions supplying cefdinir API globally?
Primarily India and China serve as the largest API producers for cefdinir, complemented by smaller contributions from South Korea and Brazil.
2. How can buyers verify the compliance of cefdinir API suppliers?
Verification through certification documents such as GMP, WHO-GMP, USFDA approval, and third-party audits ensures supplier compliance.
3. Are there risks associated with sole sourcing from a single API supplier?
Yes, reliance on a single source exposes supply chains to risks including disruptions, quality issues, and regulatory setbacks. Diversification mitigates these risks.
4. What regulatory challenges exist when sourcing cefdinir API internationally?
Regulatory variations across countries, evolving quality standards, and regional compliance requirements can pose hurdles, necessitating due diligence and ongoing regulatory monitoring.
5. How does the quality of cefdinir API influence pharmaceutical manufacturing?
High-quality API ensures efficacy, safety, and regulatory approval of finished products; substandard API can lead to defective medicines and market recalls.
References
[1] Macleods Pharmaceuticals. (2022). Corporate Website.
[2] Aurobindo Pharma. (2022). Annual Report.
Note: Additional sources include industry reports, regulatory agency publications, and company disclosures for comprehensive coverage.
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