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Suppliers and packagers for CEFACLOR
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CEFACLOR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Yung Shin Pharm | CEFACLOR | cefaclor | CAPSULE;ORAL | 065146 | ANDA | A-S Medication Solutions | 50090-1602-0 | 30 CAPSULE in 1 BOTTLE (50090-1602-0) | 2008-07-31 |
| Yung Shin Pharm | CEFACLOR | cefaclor | CAPSULE;ORAL | 065146 | ANDA | A-S Medication Solutions | 50090-1602-2 | 21 CAPSULE in 1 BOTTLE (50090-1602-2) | 2008-07-31 |
| Yung Shin Pharm | CEFACLOR | cefaclor | CAPSULE;ORAL | 065146 | ANDA | Carlsbad Technology, Inc. | 61442-171-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-01) | 2008-07-31 |
| Yung Shin Pharm | CEFACLOR | cefaclor | CAPSULE;ORAL | 065146 | ANDA | Carlsbad Technology, Inc. | 61442-171-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-05) | 2008-07-31 |
| Yung Shin Pharm | CEFACLOR | cefaclor | CAPSULE;ORAL | 065146 | ANDA | Carlsbad Technology, Inc. | 61442-171-30 | 30 CAPSULE in 1 BOTTLE, PLASTIC (61442-171-30) | 2008-07-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cefaclor
Introduction
Cefaclor is a broad-spectrum second-generation cephalosporin antibiotic used to treat various bacterial infections, including respiratory tract infections, skin infections, and urinary tract infections. As an active pharmaceutical ingredient (API), Cefaclor is manufactured and supplied by a global network of pharmaceutical companies, ranging from large multinational corporations to specialized generic drug producers. Understanding the supplier ecosystem for Cefaclor is critical for healthcare providers, pharmaceutical companies, and regulatory agencies aiming to ensure drug quality, supply chain stability, and cost-effectiveness.
Market Overview
The global demand for Cefaclor is driven by its efficacy, safety profile, and broad-spectrum activity. It is often prescribed as an alternative to penicillin in penicillin-allergic patients. The supply chain for Cefaclor involves several key stages, including raw material sourcing, API synthesis, formulation, and distribution. The major players in this space are those with validated production capabilities, regulatory compliance, and capacity to meet fluctuating market needs.
Major API Suppliers of Cefaclor
1. Teva Pharmaceutical Industries Ltd.
As one of the world's largest generic drug manufacturers, Teva supplies Cefaclor both as an API and in finished formulations. Their manufacturing facilities in Israel, Hungary, and India meet stringent cGMP standards. Teva's robust supply chain and extensive global distribution network make it a significant supplier for Cefaclor worldwide.
2. Sinochem Quanzhou Co., Ltd.
Based in China, Sinochem Quanzhou is a key API manufacturer specializing in cephalosporin APIs including Cefaclor. They have received multiple GMP certifications, emphasizing quality and regulatory compliance. Their strategic position in China allows them to offer competitive pricing and reliable supply.
3. Wockhardt Limited
An Indian pharmaceutical company with a strong reputation in cephalosporin antibiotics, Wockhardt produces Cefaclor and other cephalosporin APIs. Their facilities in India are certified by global regulatory agencies such as the US FDA and EMA, providing assurance of quality and compliance.
4. Hetero Drugs Ltd.
Hetero, headquartered in India, is a leading manufacturer of cephalosporin APIs, including Cefaclor. Their capabilities include large-scale synthesis, extensive R&D, and global registration, positioning them as a reliable supplier in the Cefaclor supply chain.
5. LloydsPharma
A rapidly growing Indian API manufacturer, LloydsPharma supplies Cefaclor among other antibiotics. They focus on cost-effective production with quality assurance, catering to both domestic and international markets.
Key Factors Influencing Supplier Selection
- Regulatory Compliance: Suppliers with FDA, EMA, or other stringent regulatory certifications assure product quality and facilitate market access.
- Manufacturing Capacity: Accurate demand forecasting is crucial; suppliers with scalable production can mitigate shortages.
- Quality Assurance: Good Manufacturing Practices (GMP), stability data, and analytical validation underpin trustworthy APIs.
- Cost Efficiency: Competitive pricing derived from efficient production processes impacts overall drug pricing.
- Supply Chain Reliability: Consistent delivery timelines and contingency planning minimize disruptions.
Emerging Suppliers and Market Dynamics
The increasing number of Chinese and Indian API manufacturers has diversified the supply landscape for Cefaclor. While this enhances supply security and competitive pricing, it also raises concerns over quality variability, emphasizing the importance of rigorous regulatory oversight. Additionally, there is a trend toward vertical integration, with some pharmaceutical companies controlling both the API production and final drug formulation.
Global suppliers are also investing in sustainable manufacturing practices and advanced purification technologies to meet evolving regulatory and environmental standards. Such innovations often translate into higher quality APIs, which are crucial for maintaining therapeutic efficacy and minimizing adverse effects.
Regulatory and Compliance Considerations
Regulatory agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) enforce stringent standards for API manufacturing. Suppliers often pursue certifications like cGMP (current Good Manufacturing Practice), ISO 9001, and Pharmacopoeia standards to demonstrate compliance.
An increasing emphasis on traceability and supply chain transparency is compelling suppliers to adopt digital traceability systems. This ensures authenticity, reduces counterfeiting risks, and enhances oversight during audits.
Impact on Market Access and Pricing
The supplier mix influences drug pricing, availability, and generic competition. A highly competitive supplier ecosystem tends to lower prices but may also introduce variability, highlighting the need for thorough due diligence and supplier qualification processes. Established suppliers with proven compliance minimize regulatory risks and expedite registration processes.
Future Outlook
The Cefaclor supply chain is poised for growth driven by expanding global antibiotics demand, particularly in emerging markets. Investments in biopharmaceutical manufacturing, process optimization, and consolidation are expected to stabilize supply and enhance quality standards. However, geopolitical factors, trade policies, and raw material availability could impact the supply chain dynamics.
Furthermore, regulatory requirements for environmental sustainability and quality are increasingly stringent. Suppliers investing in green manufacturing practices and advanced analytical technologies are better positioned for long-term success.
Key Takeaways
- The Cefaclor supply chain involves a diverse array of global producers, prominently including Teva, Sinochem Quanzhou, and Indian manufacturers like Wockhardt and Hetero.
- Regulatory compliance, manufacturing capacity, and quality assurance are critical criteria in supplier selection.
- Market dynamics are influenced by global competitiveness, technological innovation, and regulatory trends emphasizing quality and sustainability.
- Diversification of suppliers enhances supply security but necessitates rigorous quality and regulatory oversight.
- Growing demand in emerging markets underscores the importance of scalable, compliant, and cost-effective API manufacturing.
FAQs
1. Who are the leading global manufacturers of Cefaclor APIs?
Major players include Teva Pharmaceutical Industries, Sinochem Quanzhou, Wockhardt Limited, Hetero Drugs, and LloydsPharma. These companies have extensive manufacturing capabilities and regulatory certifications, enabling them to supply high-quality Cefaclor APIs worldwide.
2. What regulatory standards are most suppliers of Cefaclor expected to meet?
Suppliers should adhere to cGMP standards established by agencies like the FDA and EMA, possess ISO certifications, and provide supporting stability and analytical validation data to ensure API quality and regulatory acceptance.
3. How does supplier choice impact drug pricing and availability?
A competitive supplier landscape with multiple credible manufacturers generally leads to favorable pricing and stable supply. Conversely, reliance on limited suppliers may increase vulnerability to shortages and price fluctuations.
4. Are Chinese API manufacturers a reliable source for Cefaclor?
Yes. Many Chinese API manufacturers, such as Sinochem Quanzhou, meet international regulatory standards and are certified by multiple agencies, making them reliable, cost-effective sources. However, ongoing quality audits and verification remain critical.
5. What trends might influence the future supply of Cefaclor?
Growing demand, technological advancements, regulatory evolution, and sustainability initiatives are shaping the Cefaclor supply chain. Increased investment in manufacturing innovation and market expansion in emerging economies are likely to further diversify the supplier base.
References
- Global Market Insights. "Cephalosporin Antibiotics Market Analysis." 2022.
- USFDA. "Approved Active Pharmaceutical Ingredients." 2023.
- WHO. "GUIDELINES ON GOOD MANUFACTURING PRACTICE." 2021.
- Industry Reports on API Manufacturing and Supply Chain Dynamics.
- Company Websites and Regulatory Filings of Teva, Sinochem Quanzhou, Wockhardt, Hetero, and LloydsPharma.
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