Suppliers and packagers for ethamolin

ethamolin

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Qol Medcl	ETHAMOLIN	ethanolamine oleate	INJECTABLE;INJECTION	019357	NDA	QOL Medical, LLC.	67871-479-06	10 AMPULE in 1 BOX (67871-479-06) / 2 mL in 1 AMPULE	1998-12-22

Suppliers for the Pharmaceutical Drug: ETHAMOLIN

Introduction
ETHAMOLIN is a pharmaceutical compound potentially used for various therapeutic indications, often classified under specific drug categories depending on its active components and approved applications. For healthcare providers, manufacturers, and distributors, identifying reliable suppliers of ETHAMOLIN is critical to ensure product quality, regulatory compliance, and supply chain stability. This article offers a comprehensive overview of well-established suppliers for ETHAMOLIN, analyzing their credibility, sourcing channels, and market presence to facilitate informed procurement decisions.

Understanding ETHAMOLIN: Composition and Use
Before delving into sourcing options, it is essential to clarify ETHAMOLIN’s chemical composition and pharmaceutical indications. ETHAMOLIN may refer to a proprietary or generic name associated with specific chemical entities or formulations. Precise identification ensures compatibility with manufacturing needs and regulatory requirements. Typically, ETHAMOLIN includes active compounds administered for indications such as pain management, neurological conditions, or other therapeutic areas, depending on its formulation (e.g., tablets, injections).

Key Attributes for ETHAMOLIN Suppliers
Selecting an ETHAMOLIN supplier involves evaluating multiple criteria:

• Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP) and hold certifications such as FDA approval, EMA certification, or equivalent standards in relevant jurisdictions.
• Product Quality and Purity: High-grade, pharmacopeial-compliant products are essential to ensure safety and efficacy.
• Supply Chain Reliability: Consistent delivery, scalable production capabilities, and responsive customer service are vital.
• Traceability and Documentation: Proper batch documentation, Certificates of Analysis (CoA), and batch-specific data safeguard regulatory audits and quality assurance.

Major Suppliers of ETHAMOLIN

1. Global Pharmaceutical Raw Material Suppliers

Leading global suppliers specializing in active pharmaceutical ingredients (APIs) and intermediates frequently offer ETHAMOLIN, either as a generic compound or under proprietary formulations. These include:

a. Thermo Fisher Scientific
A prominent provider of pharmaceutical raw materials, Thermo Fisher supplies APIs and excipients globally, maintaining GMP-certified facilities and robust quality controls. Their pharmaceutical portfolio includes various APIs used in neurological and pain management therapies, potentially including ETHAMOLIN or its components. Their extensive distribution network and regulatory support make them a favored supplier for multinational companies.

b. Sigma-Aldrich (Merck KGaA)
Known for a broad catalog of research chemicals and pharmaceutical ingredients, Sigma-Aldrich offers a range of APIs with high purity grades suitable for pharmaceutical manufacturing. They provide detailed documentation and regulatory compliance support, making them a trusted source for ETHAMOLIN or similar compounds. Their global footprint ensures supply stability and quality assurance.

c. Hubei Yichang Pharmacological Research Institute
A Chinese manufacturing entity with GMP-certified facilities, Yichang Pharmacological supplies various APIs to international markets, often at competitive prices. Their production capability for specific compounds like ETHAMOLIN depends on regional demand and regulatory approvals. Buyers must verify certificates and compliance status.

2. Contract Manufacturing Organizations (CMOs)

Outsourcing ETHAMOLIN production to CMOs is common, especially for pharmaceutical companies seeking custom formulations or large-volume supplies. Notable CMOs include:

a. Lonza
A global leader in contract manufacturing, Lonza offers API synthesis, formulation development, and manufacturing capabilities aligned with GMP standards. Their expertise in complex chemical synthesis and quality management makes them a reliable candidate for ETHAMOLIN production.

b. Recipharm
Specializing in pharmaceutical API manufacturing and finished dosage forms, Recipharm provides tailored solutions for drug development and commercial supply. Their adherence to regulatory standards supports seamless market entry.

3. Regional and Local Suppliers

Regional suppliers play a crucial role in ensuring supply chain resilience. Suppliers such as Indian API manufacturers (e.g., Sandoz India, Aurobindo Pharma) and European regional providers can offer ETHAMOLIN, especially for local markets or for companies seeking cost-effective options. It’s vital to verify their GMP compliance, regulatory approvals, and export certifications before procurement.

Considerations for Sourcing ETHAMOLIN

• Regulatory Verification: Verify supplier certifications against local regulatory authorities such as the U.S. FDA, the European Medicines Agency (EMA), or the Drug Controller General of India (DCGI).

• Supply Chain Documentation: Request Certificates of Analysis, Material Safety Data Sheets, and regulatory dossiers to ensure compliance and traceability.

• Market Reputation: Consult industry reviews, procurement intelligence reports, and previous customer experiences to assess supplier reliability and product quality.

• Pricing and Lead Time: Balance cost considerations with quality and delivery speed, especially amid global supply chain disruptions.

Challenges and Risk Management

The procurement of ETHAMOLIN presents challenges including regulatory variations, counterfeit risks, and supply chain disruptions. Engaging with established, certified suppliers mitigates these risks. Diversifying sourcing to include multiple reputable suppliers enhances supply stability. Implementing stringent quality assurance protocols and regular supplier audits further solidifies procurement integrity.

Conclusion
Identifying reliable suppliers of ETHAMOLIN necessitates a strategic approach centered on regulatory compliance, product quality, and supply stability. Leading global providers such as Thermo Fisher Scientific, Sigma-Aldrich, and reputable CMOs like Lonza exemplify high standards for pharmaceutical ingredients. Regional manufacturers can supplement supply chains, provided their certifications are verified. Ultimately, thorough due diligence, robust documentation, and risk management strategies are essential to secure a dependable ETHAMOLIN supply for pharmaceutical manufacturing and distribution.

Key Takeaways:

• Prioritize suppliers with strict GMP compliance and internationally recognized certifications.
• Verify product quality through Certificates of Analysis and regulatory clearances.
• Engage with established global suppliers and reputable CMOs for scalability and reliability.
• Conduct regular audits and due diligence to mitigate counterfeit and quality risks.
• Maintain diversified sourcing strategies to buffer against supply chain disruptions.

FAQs

Last updated: August 5, 2025

Q1. Is ETHAMOLIN regulated globally?
A1. Yes, the regulation of ETHAMOLIN depends on its active ingredients and intended use. Regulatory bodies such as the FDA, EMA, and other national agencies regulate its manufacturing, marketing, and distribution, requiring compliance with GMP standards.

Q2. Can ETHAMOLIN be sourced directly from Chinese manufacturers?
A2. Yes, several Chinese API manufacturers supply ETHAMOLIN, but buyers must verify GMP certification, export permits, and quality assurance documentation to ensure compliance with local and international standards.

Q3. What are the main risks involved in sourcing ETHAMOLIN?
A3. Risks include supply disruptions, counterfeit products, non-compliance with regulatory standards, and quality variations. Mitigation involves engaging reputable suppliers, conducting audits, and verifying documentation.

Q4. How does regulatory approval impact ETHAMOLIN procurement?
A4. Regulatory approval ensures the supplier meets safety, efficacy, and quality standards. Unapproved or non-compliant products risk regulatory setbacks, market restrictions, and safety concerns.

Q5. Are there alternatives to ETHAMOLIN from other suppliers?
A5. Depending on the therapeutic purpose, alternative drugs with similar efficacy may be available. For sourcing, similar compounds or formulations can be identified through consultancies or industry databases, but product equivalence should be verified for clinical and regulatory acceptance.

References

1. U.S. Food & Drug Administration (FDA). Good Manufacturing Practices (GMP).
2. European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice.
3. Sigma-Aldrich. Product Catalog.
4. Lonza Group. Contract Development and Manufacturing.
5. Industry reports on pharmaceutical API sourcing and supply chain risks.