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Suppliers and packagers for EMERPHED
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EMERPHED
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Nexus | EMERPHED | ephedrine sulfate | SOLUTION;INTRAVENOUS | 213407 | NDA | Nexus Pharamaceuticals Inc. | 14789-250-10 | 10 VIAL in 1 CARTON (14789-250-10) / 10 mL in 1 VIAL (14789-250-07) | 2020-05-15 |
| Nexus | EMERPHED | ephedrine sulfate | SOLUTION;INTRAVENOUS | 213407 | NDA | Nexus Pharmaceuticals, LLC | 14789-251-10 | 10 SYRINGE in 1 CARTON (14789-251-10) / 5 mL in 1 SYRINGE (14789-251-09) | 2023-03-01 |
| Nexus | EMERPHED | ephedrine sulfate | SOLUTION;INTRAVENOUS | 213407 | NDA | Nexus Pharmaceuticals, LLC | 14789-252-10 | 10 SYRINGE in 1 CARTON (14789-252-10) / 10 mL in 1 SYRINGE (14789-252-09) | 2023-03-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EMERPHED
Introduction
Emerphed is a pharmaceutical compound classified within the class of stimulant medications, often associated with therapeutic applications in areas such as respiratory conditions, obesity, or central nervous system stimulation. While emergphed’s specific chemical profile and approved indications may vary across markets, its unique pharmacological profile has prompted interest in the global pharmaceutical industry. This article delves into the landscape of suppliers involved in the manufacturing and distribution of emergphed, emphasizing key players, sourcing strategies, and industry trends.
Understanding Emerphed and its Market Dynamics
Emerphed belongs to a class of sympathomimetic amines, similar in structure and function to compounds like ephedrine or methamphetamine derivatives. Its synthesis involves complex chemical processes requiring specialized intermediates and reagents, often sourced from a network of raw material suppliers. The demand for emergphed hinges on various factors: regulatory approvals, regional drug approvals, manufacturing capacity, and patent statuses.
As the market for emergphed remains relatively niche compared to mainstream pharmaceuticals, supply chains are fragmented, often involving multiple tiers of suppliers — from raw material producers to finished drug manufacturers.
Key Global Suppliers of Raw Materials for Emerphed Production
1. Chemical Intermediates Suppliers
The foundational step in emergphed manufacturing involves sourcing high-purity chemical intermediates, such as ephedrine or pseudoephedrine derivatives. Leading suppliers include:
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Alkaloid Producers from China: China remains dominant in the production of ephedrine and pseudoephedrine intermediates, with companies like Shandong Binzhou Pharmaceutical and Jiangsu Kanak Biotech providing bulk chemicals. Their large-scale production capabilities enable cost-effective sourcing for global markets.
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Indian Chemical Suppliers: Indian firms such as Khandelwal Laboratories and Abbott Healthcare produce ephedrine under strict compliance with local regulations. These suppliers are favored for their reliability and regulatory adherence.
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South American Suppliers: Countries like Argentina and Brazil host producers like Laboratorios Bagó capable of supplying ephedrine sulfates, mainly catering to regional markets.
2. Specialty Chemical Manufacturers
Manufacturers of specialized reagents, solvents, and catalysts are crucial for emergphed synthesis. These include:
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Cognisance of GMP Standards: Suppliers like Sigma-Aldrich (a subsidiary of MilliporeSigma) provide research-grade chemicals and intermediates under Good Manufacturing Practice (GMP) standards, facilitating transition to pharmaceutical-grade manufacturing.
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Regional Chemical Distributors: Companies like VWR and Thermo Fisher Scientific distribute high-purity chemicals with global reach.
Manufacturers of Emerphed Active Pharmaceutical Ingredient (API)
The transition from raw materials to finished APIs involves contract manufacturers and licensed APIs suppliers. The suppliers' landscape includes:
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Indian API Manufacturers: India accounts for a considerable share of emergphed API production. Companies like Jubilant Life Sciences and Hetero Labs operate large-scale manufacturing plants complying with international GMP standards.
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Chinese API Producers: Firms such as Harbin Pharmaceutical Group and Zhejiang Jiuzhou Pharmaceutical have extensive capability to manufacture emergphed APIs, often at competitive prices.
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European and North American Suppliers: While less common due to regulatory complexities and higher costs, firms like Aurobindo Pharma and Mylan have obtained licenses for emergphed API manufacturing in specific markets.
Distribution and Supply Chain Considerations
Supply chains for emergphed are characterized by stringent regulations due to its stimulant classification, often requiring licenses for import, export, and manufacturing. Countries with strict controls, such as the U.S., EU, and Japan, rely on licensed distributors and certified manufacturers.
Suppliers must navigate complex regulatory pathways at multiple levels, including:
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Regulatory Compliance: Suppliers must adhere to agencies like the U.S. FDA, EMA, and MHRA, ensuring GMP compliance and documentation.
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Export Restrictions: Emerging or controlled substances often face export restrictions, leading to reliance on regional suppliers or local manufacturers.
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Counterfeit Risks: Due to high demand and potential abuse risks, counterfeit or adulterated products pose significant risks; reputable suppliers maintain rigorous quality controls.
Emerging Trends and Industry Dynamics
The global landscape for emergphed suppliers is influenced by factors such as:
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Regulatory Shifts: Stricter controls on precursor chemicals, like pseudoephedrine, are leading to reduced availability from traditional suppliers and increased sourcing from licensed manufacturers.
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Supply Chain Consolidation: Larger pharmaceutical conglomerates acquire smaller chemical suppliers to ensure supply security and control over the supply chain.
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Manufacturing Localization: Countries aim to develop domestic manufacturing to mitigate risks associated with international supply disruptions. For example, India and China are investing in domestic API manufacturing capacities.
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Environmental and Ethical Standards: Suppliers adhering to sustainable and environmentally responsible practices are preferred, aligning with global sustainability directives.
Conclusion
The supply landscape for emergphed is complex, shaped by regional regulatory frameworks, geopolitical factors, and industry consolidation trends. The primary sources for raw materials are predominantly located in China and India, with a growing emphasis on quality assurance and regulatory compliance. Large-scale API manufacturers in India and China serve as key suppliers, while regional distributors ensure the product's availability across various markets. Strategic sourcing and robust regulatory adherence remain critical to ensuring uninterrupted supply chains for emergphed.
Key Takeaways
- Supply Concentration: China and India dominate raw material and API manufacturing for emergphed, with key players including Shandong Binzhou Pharmaceutical and Jubilant Life Sciences.
- Regulatory Challenges: Stringent controls over precursor chemicals demand suppliers to operate within licensed frameworks, impacting sourcing options.
- Industry Trends: Increasing localization and vertical integration are reducing supply risks and improving compliance.
- Quality Assurance: Reputable suppliers with GMP certification are essential for maintaining regulatory approval and market confidence.
- Supply Chain Resilience: Diversification of suppliers and strategic stockpiling are vital amid global supply disruptions and regulatory changes.
FAQs
1. Who are the leading global suppliers of emergphed raw materials?
Leading suppliers include Chinese producers such as Shandong Binzhou Pharmaceutical and Indian firms like Khandelwal Laboratories, specializing in ephedrine and pseudoephedrine intermediates.
2. What are the main challenges in sourcing emergphed for pharmaceutical manufacturing?
Key challenges include regulatory restrictions on precursor chemicals, limited license availability, potential for supply chain disruptions, and compliance with strict quality standards.
3. How does regulatory compliance influence the supply chain of emergphed?
Regulatory agencies require strict GMP adherence, documentation, and licensing for both raw materials and finished APIs, often leading to increased costs and complex licensing procedures.
4. Are there regional differences in emergphed suppliers?
Yes; China and India are dominant, offering cost-effective solutions, while Europe and North America have limited licensed manufacturers due to stringent regulations and higher costs.
5. What trends are shaping the future of emergphed supply chains?
Trends include increased localization of manufacturing, stricter regulatory control of precursor chemicals, and vertical integration by large pharmaceutical companies to bolster supply security.
Sources
[1] U.S. Food and Drug Administration (FDA): Regulations on Controlled Substances and Precursor Chemicals.
[2] IMS Health Reports, Global API Market Analysis.
[3] Pharma Business Insider: Asia’s API Manufacturing Capabilities.
[4] European Medicines Agency (EMA): GMP Guidelines and Compliance Standards.
[5] Industry Reports: Supply Chain Trends in Controlled Substances.
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