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Suppliers and packagers for ERYTHROMYCIN LACTOBIONATE
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ERYTHROMYCIN LACTOBIONATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Gland | ERYTHROMYCIN LACTOBIONATE | erythromycin lactobionate | INJECTABLE;INJECTION | 216761 | ANDA | Gland Pharma Limited | 68083-513-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01) | 2024-11-19 |
| Nexus | ERYTHROMYCIN LACTOBIONATE | erythromycin lactobionate | INJECTABLE;INJECTION | 215290 | ANDA | Nexus Pharmaceuticals LLC | 14789-116-05 | 5 VIAL, GLASS in 1 BOX (14789-116-05) / 10 mL in 1 VIAL, GLASS (14789-116-07) | 2021-08-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Erythromycin Lactobionate
Introduction
Erythromycin lactobionate is a salt form of erythromycin, a macrolide antibiotic primarily used to treat various bacterial infections such as respiratory tract infections, skin infections, and sexually transmitted diseases. Its pharmaceutical manufacturing relies on a complex supply chain involving high-quality raw materials, active pharmaceutical ingredients (APIs), and specialized excipients. Understanding the global suppliers of erythromycin lactobionate is essential for pharmaceutical companies, distributors, and healthcare providers aiming to ensure drug stability, efficacy, and regulatory compliance. This report analyzes key suppliers across the supply chain, evaluating their production capacity, geographic presence, and regulatory standing.
Manufacturers of Erythromycin Lactobionate
The production of erythromycin lactobionate is highly specialized, primarily involving seasoned pharmaceutical ingredient manufacturers capable of complying with Good Manufacturing Practices (GMP) and international quality standards.
Major Suppliers:
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Pfizer Inc.
As a pioneer in antibiotic development, Pfizer supplies erythromycin derivatives, including erythromycin lactobionate, through its global manufacturing network. Pfizer emphasizes stringent quality control, regulatory compliance, and comprehensive supply chain management to serve both clinicians and pharmaceutical partners worldwide. However, specific batch-level supplier details are often proprietary, and Pfizer typically supplies the compound through authorized distributors or contract manufacturing organizations (CMOs). -
Lupin Limited
An Indian pharmaceutical giant, Lupin manufactures erythromycin lactobionate primarily for domestic and international markets. Lupin’s manufacturing facilities across India are GMP-certified, meeting stringent criteria set by the FDA and EDQM (European Directorate for the Quality of Medicines). Their capacity to produce high-purity erythromycin salts positions them as a significant supplier for global API markets. -
Cipla Limited
Cipla’s robust portfolio includes erythromycin APIs, with erythromycin lactobionate being produced in their facilities in India and possibly in strategic partnerships in Europe. Cipla prioritizes quality, affordability, and regulatory compliance, making it a dependable choice for pharmaceutical companies seeking reliable supply. -
Hubei Sanonda Co., Ltd.
Based in China, Hubei Sanonda is a notable supplier of erythromycin derivatives, including erythromycin lactobionate. They have established a track record of producing high-quality APIs, leveraging advanced manufacturing infrastructure, and adhering to GMP standards recognized by regulatory bodies. -
Venkatesh Naturals & Chemicals
An emerging player in the API sector, Venkatesh Naturals specializes in erythromycin salts, including erythromycin lactobionate for regional markets in Asia and Africa. Their focus on quality and competitive pricing bolsters their position as a key regional supplier.
Supply Chain Considerations
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Raw Material Sourcing:
The synthesis of erythromycin lactobionate involves complex fermentation and chemical manufacturing processes, often relying on raw materials like erythromycin base, lactose, and various reagents. Suppliers of these raw materials considerably influence the overall supply chain integrity. -
Quality Certification:
Regulatory agencies, including the FDA, EMA, and WHO, mandate stringent quality standards. Suppliers must hold certifications like GMP, DMF (Drug Master File), and CEP (Certificate of Suitability) to ensure compliance and facilitate global distribution. -
Geographical Distribution:
The primary manufacturing hubs are located in North America (e.g., Pfizer), Europe (e.g., EMA-approved facilities), and Asia (India and China). Diversification across these regions mitigates supply risks in response to geopolitical or logistical disruptions.
Regulatory Landscape and Impact on Suppliers
The approval status and regulatory compliance of suppliers significantly influence procurement strategies. Suppliers with established regulatory acceptance can expedite market access and product registration—important factors for pharmaceutical companies aiming for rapid deployment.
Emerging Trends and Future Outlook
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Supply Chain Resilience:
The COVID-19 pandemic underscored the importance of diversified sourcing and local manufacturing capabilities. Suppliers investing in capacity expansion and advanced manufacturing facilities are better positioned for future demand surges. -
Sustainable and Green Manufacturing:
Increasing emphasis on environmentally sustainable processes is shaping supplier practices. Companies adopting green chemistry and energy-efficient manufacturing methods will likely appeal more to global buyers prioritizing ESG (Environmental, Social, and Governance) criteria. -
Partnerships and Technology Transfers:
Strategic collaborations between original manufacturers and regional players aim to secure supply continuity, especially amid rising global demand for antibiotics.
Conclusion
Erythromycin lactobionate’s supply chain is characterized by a mixture of established global pharmaceutical giants and regional manufacturers specializing in macrolide antibiotics. Leading companies like Pfizer, Lupin, Cipla, Hubei Sanonda, and Venkatesh Naturals are key players, leveraging extensive manufacturing capacity, regulatory compliance, and geographical reach. Continuous industry evolution driven by supply chain resilience, sustainability, and regulatory adaptation will influence supplier dynamics in the coming years.
Key Takeaways
- The primary suppliers of erythromycin lactobionate include Pfizer, Lupin, Cipla, Hubei Sanonda, and regional manufacturers in Asia.
- Regulatory compliance and manufacturing capacity are critical factors influencing supplier selection.
- Diversification of sourcing across different regions minimizes supply risks amid geopolitical and logistical challenges.
- Transparency about manufacturing practices and certifications enhances supplier reliability.
- Innovation in green manufacturing and strategic partnerships will shape future supply chain resilience.
FAQs
1. What are the main regions supplying erythromycin lactobionate globally?
Primarily North America, Europe, and Asia—especially India and China—serve as the major hubs for manufacturing erythromycin lactobionate, with companies like Pfizer and Lupin leading production.
2. What regulations must suppliers meet to export erythromycin lactobionate internationally?
Suppliers must comply with GMP standards, possess necessary certifications such as FDA DMFs or EMA CEPs, and ensure their manufacturing processes meet regional requirements.
3. How has the COVID-19 pandemic affected erythromycin lactobionate supply chains?
The pandemic exposed vulnerabilities, prompting companies to diversify suppliers, increase inventories, and invest in local manufacturing to enhance resilience.
4. Are there sustainable practices among suppliers of erythromycin lactobionate?
While some large manufacturers are adopting green chemistry initiatives and energy-efficient processes, sustainability practices vary. Buyers increasingly favor suppliers with proven ESG commitments.
5. How can pharmaceutical companies verify the quality of erythromycin lactobionate suppliers?
By reviewing certification documents (GMP, DMF, CEP), conducting audits, assessing production capacity, and evaluating prior regulatory approvals and compliance history.
References
- U.S. Food and Drug Administration (FDA). Directory of approved drug substances. https://www.fda.gov/drugs/development-approval-process/drug-master-files
- European Directorate for the Quality of Medicines & HealthCare (EDQM). Certificate of Suitability (CEP) database. https://www.edqm.eu/en/cep-db
- Pharmaceutical Technology. "Global API manufacturing landscape." 2022.
- MarketWatch. "Global antibiotics market analysis." 2023.
- Industry Reports. "Sustainable practices in pharmaceutical APIs." 2022.
This comprehensive analysis aims to assist pharmaceutical and healthcare stakeholders in understanding erythromycin lactobionate suppliers, thereby optimizing procurement strategies and ensuring supply chain robustness.
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