Share This Page
Suppliers and packagers for eryped
✉ Email this page to a colleague
eryped
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Carnegie | ERYPED | erythromycin ethylsuccinate | GRANULE;ORAL | 050207 | NDA | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-130-13 | 100 mL in 1 BOTTLE (24338-130-13) | 2012-06-14 |
| Carnegie | ERYPED | erythromycin ethylsuccinate | GRANULE;ORAL | 050207 | NDA | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-132-13 | 100 mL in 1 BOTTLE (24338-132-13) | 2011-07-05 |
| Carnegie | ERYPED | erythromycin ethylsuccinate | GRANULE;ORAL | 050207 | NDA | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-134-02 | 100 mL in 1 BOTTLE (24338-134-02) | 2011-04-18 |
| Carnegie | ERYPED | erythromycin ethylsuccinate | GRANULE;ORAL | 050207 | NDA | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-136-10 | 200 mL in 1 BOTTLE (24338-136-10) | 2011-04-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ERYPED
Introduction
Eryped, a pharmaceutical formulation primarily based on the active ingredient erythromycin, serves as an effective antibiotic used to treat a broad spectrum of bacterial infections. The global demand for erythromycin-based products has surged due to rising infections and antibiotic-resistant bacteria, prompting increased interest in reliable suppliers. This article explores the landscape of suppliers for ERYPED, emphasizing manufacturing origins, quality standards, supply chain considerations, and market dynamics critical for stakeholders in pharmaceutical procurement and distribution.
Overview of ERYPED and Erythromycin
Eryped is a trade name associated with erythromycin-containing formulations, often in the form of powder, tablets, or suspensions. As a macrolide antibiotic, erythromycin inhibits bacterial protein synthesis, making it a staple in infectious disease treatment. Its production requires stringent quality controls and adherence to regulatory standards, including those of the FDA, EMA, and WHO.
The global supply chain for erythromycin and its formulations is complex, involving several key manufacturing regions and suppliers. The consolidation of trusted manufacturers is crucial for pharmaceutical companies seeking dependable sources for ERYPED.
Key Manufacturers and Suppliers of ERYPED
1. Mylan (Viatris)
Mylan, a subsidiary of Viatris, is a prominent global producer of erythromycin formulations, including ERYPED. With manufacturing facilities in North America, Europe, and Asia, Mylan adheres to international Good Manufacturing Practices (GMP). The company’s extensive distribution network ensures reliable supply and competitive pricing. Their erythromycin products are approved by major regulatory authorities, offering confidence in quality and safety.
2. Teva Pharmaceutical Industries
Teva is a leading global generic drug manufacturer with a significant portfolio of antibiotics, including erythromycin-based products. Their manufacturing operations span Israel, Europe, and North America. Teva’s compliance with rigorous GMP standards makes it a trusted supplier for ERYPED in various markets.
3. Pfizer
Pfizer is a longstanding pharmaceutical leader with a history of producing erythromycin formulations, often branded as Erythroped or similar names. While Pfizer’s focus has shifted towards innovative therapies, their legacy erythromycin manufacturing facilities remain key suppliers, particularly in established markets.
4. Canadian-based Pharmaceutical Manufacturers
Companies such as Glenmark and Apotex have invested in erythromycin manufacturing facilities, especially in India and Canada. These companies supply generic erythromycin formulations to different global markets, often providing cost-effective alternatives.
5. Local and Regional Suppliers
In addition to multinational corporations, regional suppliers in Asia (notably China and India) have emerged as key players. Manufacturers such as Shanghai Pharmaceuticals and Dr. Reddy’s Laboratories produce erythromycin formulations that may be sourced for ERYPED, subject to regulatory approval and quality verification.
Quality Standards and Regulatory Compliance
The reliability of ERYPED suppliers hinges on adherence to international quality standards. Suppliers must meet GMP requirements, ensuring product purity, potency, and bioavailability. Regulatory approvals from agencies like the FDA, EMA, or WHO pre-certify manufacturing standards and ease import/export barriers. Notably:
- Manufacturing Licenses: Verified and current.
- Raw Material Sourcing: Strict controls for erythromycin raw substances.
- Stability and Efficacy Testing: Ongoing batch testing to confirm compliance.
Procurement professionals should verify supplier certifications and batch records before establishing long-term partnerships.
Supply Chain Considerations
Supply stability for ERYPED depends on multiple factors:
- Manufacturing Capacity: Manufacturers with diversified plants reduce risks associated with regional disruptions.
- Logistics and Distribution: Reliable freight routes, warehousing, and customs clearance are vital.
- Regulatory Environment: Variations in approval status across countries influence manufacturer participation.
- Pricing and Contract Terms: Long-term agreements can mitigate fluctuations in cost and supply.
- Raw Material Availability: Global erythromycin raw material supply chains can impact production schedules.
Due diligence on supplier capacity and resilience becomes critical amidst geopolitical tensions, pandemics, and global shortages.
Emerging Trends and Future Outlook
The erythromycin and ERYPED market is evolving with advancements in biotechnology and manufacturing digitization. Suppliers investing in process automation and quality analytics improve product consistency. Additionally, increased legislation focusing on antibiotic stewardship may influence the selection of suppliers committed to responsible manufacturing practices.
The rise of regional manufacturing hubs, especially in India and China, provides cost advantages but also raises concerns about quality verification and regulatory compliance. As global health agencies emphasize antimicrobial stewardship, suppliers who invest in responsible production and supply chain transparency will have competitive advantages.
Regulatory Challenges and Certification Strategies
To ensure seamless procurement, stakeholders should prioritize suppliers with:
- WHO Prequalification: Facilitates access in low-income markets.
- US FDA Approval or EEA Certification: Ensures compliance for export markets.
- ISO Certifications: Demonstrates adherence to international quality standards.
- Advanced traceability systems: To minimize counterfeit risks.
Effective supplier qualification processes include on-site audits, review of batch records, and ongoing supplier performance monitoring.
Conclusion
The landscape for ERYPED suppliers remains diverse, with trusted multinational corporations like Mylan, Teva, and Pfizer at the forefront, supported by regional producers from Asia. Ensuring product quality, regulatory compliance, and supply chain resilience is paramount for stakeholders aiming to maintain consistent availability of erythromycin formulations. As global health priorities shift and manufacturing technologies advance, the capacity of suppliers to adapt and uphold high standards will define their market success.
Key Takeaways
- Reliability is key: Prioritize suppliers with proven GMP compliance and regulatory approvals.
- Diversify sources: Engage with multiple manufacturers, especially regional suppliers, to mitigate supply disruptions.
- Verify certifications: Regularly audit supplier certifications such as WHO prequalification, FDA approval, and ISO standards.
- Monitor market trends: Stay alert to advancements in manufacturing and evolving global health policies affecting erythromycin supply.
- Focus on supply chain transparency: Transparent processes reduce risks associated with counterfeit or substandard products.
FAQs
1. Who are the major global manufacturers supplying ERYPED?
Leading suppliers include Mylan (Viatris), Teva, Pfizer, and regional producers such as Glenmark and Apotex. Many of these companies hold GMP certification and regulatory approvals, ensuring product quality.
2. What quality standards should ERYPED suppliers meet?
Suppliers must adhere to GMP standards, possess relevant regulatory approvals (FDA, EMA, WHO prequalification), and implement robust quality assurance protocols to ensure product efficacy and safety.
3. How can buyers verify a supplier’s compliance?
Verification involves reviewing certification documentation, conducting on-site audits, examining batch records, and performing ongoing supplier performance evaluations.
4. What challenges exist in sourcing ERYPED globally?
Global challenges include regulatory variances, raw material shortages, geopolitical risks, and logistical disruptions—particularly highlighted by recent global health emergencies.
5. What trends are shaping the future of ERYPED supply?
Emerging trends include increased regional manufacturing, investments in supply chain transparency, technological integration in production, and a focus on antibiotic stewardship to promote responsible usage.
References
[1] World Health Organization. (2021). Prequalification of Medicines Programme.
[2] U.S. Food and Drug Administration. (2022). Approved Drug Products.
[3] European Medicines Agency. (2022). List of Authorized Medicinal Products.
[4] IQVIA. (2022). Global Pharmaceutical Market Insights.
[5] Pharma Intelligence. (2022). Market Analysis Reports on Antibiotics Manufacturing and Supply.
More… ↓
