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Suppliers and packagers for generic pharmaceutical drug: NEOMYCIN SULFATE
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NEOMYCIN SULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aarxion Anda Hlding | NEOMYCIN SULFATE | neomycin sulfate | TABLET;ORAL | 065220 | ANDA | Solaris Pharma Corporation | 73473-901-05 | 100 TABLET in 1 BOTTLE, PLASTIC (73473-901-05) | 2023-06-01 |
| Chartwell Molecular | NEOMYCIN SULFATE | neomycin sulfate | TABLET;ORAL | 204435 | ANDA | Chartwell RX, LLC | 62135-443-90 | 90 TABLET in 1 BOTTLE (62135-443-90) | 2016-06-10 |
| Teva | NEOMYCIN SULFATE | neomycin sulfate | TABLET;ORAL | 060304 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1177-01 | 100 TABLET in 1 BOTTLE (0093-1177-01) | 1990-09-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Neomycin Sulfate
Introduction
Neomycin sulfate is a broad-spectrum aminoglycoside antibiotic primarily used in the treatment of intestinal infections, skin infections, and eye conditions. Its efficacy, stability, and established manufacturing processes have fostered a robust global supply chain, with suppliers ranging from established pharmaceutical giants to regional manufacturers. This article provides a comprehensive overview of primary suppliers of neomycin sulfate, considering manufacturing capacity, regulatory compliance, market presence, and supply reliability. For pharmaceutical companies and healthcare providers, understanding the landscape of neomycin sulfate suppliers ensures seamless procurement, regulatory adherence, and quality assurance.
Manufacturers and Key Suppliers of Neomycin Sulfate
1. Global Pharmaceutical Manufacturers
a. Chiral Laboratories
Chiral Laboratories is a leading manufacturer of amino glycosides, including neomycin sulfate. Located in India, they produce high-quality APIs compliant with international standards such as USP, EP, and BP. Their facilities are equipped with advanced synthesis and purification technologies, enabling large-scale production to meet global demand.
b. Ajinomoto Co., Inc.
A major Japanese pharmaceutical and chemical company, Ajinomoto manufactures various antibiotics, including neomycin sulfate. Their facilities adhere to strict Good Manufacturing Practices (GMP), and they export to numerous countries, ensuring a consistent supply chain backed by robust R&D.
c. Wuhan Eloson Pharmaceutical Co., Ltd.
Based in China, Wuhan Eloson is known for producing antibiotics, including neomycin sulfate, often offering cost-effective options for global markets. Their manufacturing processes meet regulatory standards and provide APIs suitable for pharmaceutical formulations.
d. Bachem AG
Although primarily focused on peptide synthesis, Bachem AG also supplies various APIs, including amino glycosides, with quality controls fitting international standards. Their global distribution network ensures availability for research and commercial use.
2. Regional and API-Specific Suppliers
a. Aegis Pharma
Based in India, Aegis Pharma supplies neomycin sulfate in various forms, including powders and premixed formulations. They emphasize regulatory compliance, quality, and reliable delivery timelines.
b. Sun Pharmaceutical Industries Ltd.
One of India’s largest pharmaceutical companies, Sun Pharma produces and supplies numerous antibiotics, including neomycin sulfate, leveraging extensive manufacturing capacities and established distribution channels.
c. Qingdao Laike Biological Technology Co., Ltd.
A Chinese API manufacturer known for cost-effective antibiotics, Qingdao Laike offers neomycin sulfate with certification for export markets, adhering to regulatory standards.
3. Contract Manufacturing and OE Suppliers
Several contract manufacturing organizations (CMOs) globally offer custom synthesis of neomycin sulfate, often serving niche markets or formulation-specific needs. These players include:
- IPCA Laboratories Ltd. (India): Specializes in antibiotic APIs, including neomycin sulfate.
- Hubei Biocause Pharmaceutical Co., Ltd. (China): Offers custom APIs with regulatory compliance.
4. Considerations When Selecting Suppliers
- Regulatory Compliance: Suppliers must meet WHO GMP, US FDA, EMA, or other relevant standards.
- Quality Assurance: Certification (ISO, cGMP) and consistent batch quality are essential.
- Supply Capacity: Ability to meet short-term and long-term demands.
- Pricing and Lead Times: Cost competitiveness coupled with reliable delivery schedules.
- Traceability and Documentation: Transparency regarding raw materials and process controls.
Regulatory and Quality Considerations
Suppliers of neomycin sulfate are often subject to elaborate regulatory scrutiny owing to the antibiotic's critical role in therapeutics. Manufacturers should maintain compliance with pharmacopoeial standards (USP, EP, BP) and adhere to international GMPs. Importantly, batch-to-batch consistency and stability data ensure efficacy and safety of the final pharmaceutical products.
Supply Chain Dynamics and Market Trends
The global supply landscape reflects geopolitical considerations, manufacturing capacity, and regulatory shifts. India and China remain dominant suppliers due to cost advantages and large-scale manufacturing, but increasing regulatory stringencies necessitate rigorous quality control. Manufacturers investing in process innovation and quality management systems are better positioned to sustain long-term supply commitments.
Emerging Markets and Future Outlook
Growing demand in emerging markets continues to shape the supply chain. Diversification of manufacturing sources is vital to mitigate risks such as geopolitical disruptions or raw material shortages. Advances in synthetic methodologies and bioengineering may also influence future supplier profiles.
Conclusion
The procurement of neomycin sulfate hinges on selecting suppliers with proven quality, compliance, capacity, and reliability. Notable global suppliers include Chiral Laboratories, Ajinomoto, and Indian giants like Sun Pharma and Aegis Pharma. Strategic sourcing from multiple regions and rigorous supplier qualification standards underpin a resilient supply chain essential for pharmaceutical manufacturers, healthcare providers, and distributors.
Key Takeaways
- Global Diversification: Engaging multiple suppliers from India, China, and Japan reduces supply chain risks.
- Regulatory Alignment: Ensuring suppliers meet pharmacopoeial and GMP standards is critical for quality assurance.
- Capacity and Stability: Prioritize suppliers with proven large-scale manufacturing capabilities and consistent quality records.
- Cost and Lead Times: Balancing cost-effectiveness with reliable delivery schedules optimizes procurement strategies.
- Future Trends: Embrace emerging manufacturing technologies and diversify sourcing to mitigate geopolitical and regulatory risks.
FAQs
1. What are the primary regions supplying neomycin sulfate globally?
India and China are the predominant suppliers due to large-scale manufacturing and cost advantages. Japan also supplies high-quality neomycin sulfate, especially for regulated markets.
2. How can I verify a supplier’s regulatory compliance?
Request official certificates such as GMP certifications, ISO certifications, and pharmacopeial compliance documentation. Additionally, conducting audits and quality assessments ensures adherence to standards.
3. What quality standards should suppliers of neomycin sulfate meet?
Suppliers should comply with USP, EP, or BP pharmacopoeial standards, along with cGMP and ISO certifications, to ensure the API's purity, potency, and safety.
4. How do market trends influence the supply of neomycin sulfate?
Increasing demand in emerging markets, combined with regulatory requirements and geopolitical factors, influence supply sourcing strategies, manufacturing investments, and pricing.
5. Are there any emerging suppliers or innovations in neomycin sulfate production?
Yes. Advances in synthetic biology and fermentation techniques may enable new suppliers to enter global markets, potentially offering improved purity, cost savings, or environmentally sustainable manufacturing processes.
References
[1] World Health Organization. (2021). Pharmacovigilance for antibiotics. WHO Publications.
[2] United States Pharmacopeia. (2022). USP Monograph for Neomycin Sulfate.
[3] European Pharmacopoeia. (2022). Neomycin Sulfate Monograph.
[4] Ajinomoto Co., Inc. Corporate website. (2023). Manufacturing and Product Portfolio.
[5] Pharmaceutical Business Review. (2022). Global Neomycin Sulfate Market Analysis.
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