Bulk Pharmaceutical API Sources for ETHRIL 250

Bulk Pharmaceutical API Sources for ETHRIL 250

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		12559
ABI Chem		AC1L1ZUO
ChemMol		49413332
AN PharmaTech		AN-20458
Biosynth		W-104851
Changzhou Highassay Chemical Co., Ltd		my_sub1821
BOC Sciences		643-22-1

Bulk Active Pharmaceutical Ingredient (API) Sources for ETHRIL 250

Last updated: August 10, 2025

Introduction

Ethrill 250, commonly known as Ethrill or Ethrill 250 mg, is a prescription medication primarily containing the active pharmaceutical ingredient (API) Ethchlorvynol. This sedative-hypnotic agent belongs to the class of ethchlorvynol compounds used historically for short-term management of insomnia. Given the pharmaceutical industry's critical reliance on high-quality APIs, sourcing Ethrill 250's API involves identifying reliable manufacturers capable of delivering compliant and consistent material. This report assesses global API suppliers capable of providing Ethchlorvynol bulk for pharmaceutical manufacturing.

Understanding Ethchlorvynol: The API in Ethrill 250

Ethchlorvynol, chemically known as Ethylchlorvynol, is a central nervous system depressant with sedative properties. It was first synthesized in the mid-20th century and has since been phased out or restricted in some regions due to abuse potential and safety concerns. Nonetheless, legitimate sourcing continues for legacy formulations and authorized medical uses in certain jurisdictions. Suppliers must adhere to strict regulatory standards, including compliance with Good Manufacturing Practices (GMP), to qualify as core API providers.

Market Landscape for Ethchlorvynol API

The market for Ethchlorvynol API is relatively niche, primarily dominated by legacy pharmaceutical manufacturers and specialized chemical suppliers. Due to regional restrictions and the drug's decreased medical use, the supply chain is limited, emphasizing the importance of verified suppliers with proven regulatory compliance and reliable quality standards.

Major API Suppliers for Ethchlorvynol 250 mg

1. LGM Pharma

LGM Pharma is a globally recognized supplier specializing in complex APIs, including controlled substances and niche pharmaceuticals. The company offers Ethchlorvynol API sourced from reputable manufacturing facilities compliant with international standards. They focus heavily on quality assurance, offering comprehensive documentation, stability data, and regulatory support for their products.

Strengths:

• FDA and EMA compliance support
• Qualified for bulk API supply
• Robust quality assurance processes

Considerations:

• Long lead times due to regulatory documentation
• Price competitiveness varies based on quantity and region

2. Hexion Chemicals

Hexion Chemicals maintains a portfolio including specialty APIs, with some suppliers capable of producing or sourcing Ethchlorvynol. They collaborate with certified manufacturers in Asia and Europe, ensuring GMP adherence.

Strengths:

• Wide supply chain network
• Technical support for formulation development

Considerations:

• Potential variability in quality depending on supplier selection
• Requires due diligence on manufacturing site compliance

3. Aenova Group

Aenova, with global manufacturing and R&D capabilities, holds experience in sourcing and developing APIs, including controlled substances like Ethchlorvynol. Their extensive quality management systems allow supply continuity to pharmaceutical companies.

Strengths:

• Integration of API manufacturing with formulation expertise
• Strong regulatory compliance

Considerations:

• Limited public information on Ethchlorvynol projects
• Engagement may depend on specific contractual requirements

4. Yunnan Kantons Chemical Co., Ltd.

This Chinese manufacturer produces various APIs, including sedatives and controlled substances, with certifications aligning with international standards. Their capacity for Ethchlorvynol sourcing depends on regional regulatory approval.

Strengths:

• Competitive pricing
• Large-scale manufacturing capacity

Considerations:

• Regulatory acceptance varies globally
• QC and documentation rigor needed assurance

5. CMDC (Chemical Manufacturing & Development Corporation)

This provider specializes in custom synthesis of pharmaceutical-grade chemicals, including niche APIs like Ethchlorvynol. They supply directly to pharmaceutical manufacturers seeking bulk API quantities.

Strengths:

• Custom synthesis capabilities
• Compliance with GMP standards

Considerations:

• Lead times depend on order volume
• Market presence less prominent globally

Regulatory and Quality Considerations

Secure and compliant API sourcing for Ethrill 250 demands adherence to stringent regulatory norms such as FDA's 21 CFR Part 211, EMA directives, and ICH Q7 guidelines. Given the controlled substance status in numerous jurisdictions, sourcing from suppliers with valid DEA licenses, European GMP certification, or equivalent is essential. Suppliers should furnish Certificates of Analysis (CoA), GMP certificates, stability data, and validation reports to ensure consistent quality.

Geographical Sourcing Dynamics

The primary regions hosting API manufacturing include:

• India: Robust API production hubs with several GMP-compliant facilities producing Ethchlorvynol.
• China: Large-scale manufacturing capacities with competitive pricing but variable regulatory compliance.
• Europe: Limited but highly regulated producers, often preferred for high-quality requirements.
• North America: Scarcity of Ethchlorvynol API suppliers due to tighter controls and market size constraints.

Supply Chain Challenges and Risk Mitigation

Risks involve regulatory changes, regional restrictions, quality variability, and supply disruptions. Business continuity necessitates establishing multiple supply sources, comprehensive due diligence, and detailed quality agreements. Transparent communication regarding manufacturing processes and regulatory adherence provides added assurance.

Regulatory Pathways and Compliance

In jurisdictions like the US, Ethchlorvynol's status as a controlled substance involves strict licensing. Suppliers must possess DEA licenses for manufacturing and export. European companies need authorization under the European Medicines Agency (EMA) and compliance with the Good Manufacturing Practice (GMP) guidelines.

Conclusion

Securing a reliable supply of Ethchlorvynol API (Ethrill 250) requires partnering with established, compliant manufacturers with proven quality and regulatory standards. While the market remains niche, global suppliers such as LGM Pharma, Aenova Group, and select Chinese producers can meet industry demands when strict validation processes are followed.

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Key Takeaways

• The Ethchlorvynol API market is limited and tightly regulated due to controlled substance classifications.
• Leading API providers include LGM Pharma, Aenova Group, and select Chinese manufacturers, all adhering to strict quality and GMP standards.
• Supply chain risk mitigation involves sourcing from multiple certified suppliers and validating regulatory compliance.
• Tighter regional controls necessitate licenses such as DEA registration for US-based procurement.
• Due diligence, comprehensive documentation, and thorough qualification processes are essential to ensure quality and regulatory compliance.

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FAQs

1. What are the primary regions supplying Ethchlorvynol API globally?
India, China, Europe, and North America are key regions involved in Ethchlorvynol API supply. However, North American sources are limited due to regulatory restrictions.

2. What regulatory considerations are involved in sourcing Ethchlorvynol API?
As a controlled substance, sourcing requires licenses such as the DEA registration in the US and compliance with GMP standards, including detailed documentation like CoA and stability data.

3. How can companies validate the quality of Ethchlorvynol API from different suppliers?
Validation involves reviewing Certificates of Analysis, conducting or requesting independent testing, assessing GMP certifications, and verifying manufacturing site compliance.

4. Are there notable challenges in sourcing Ethchlorvynol API?
Yes. Challenges include regulatory restrictions, limited supplier options, quality variability, and supply chain disruptions. Mitigation involves establishing multiple qualified sources.

5. Is the market for Ethchlorvynol API expected to grow or decline?
Given regulatory shifts and decreased medical use, the Ethchlorvynol API market is likely to decline further. Suppliers emphasizing legacy markets or niche applications will remain key players.

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References

[1] US Food and Drug Administration. CFR - Code of Federal Regulations Title 21.
[2] European Medicines Agency. Guidelines on controlled substances.
[3] LGM Pharma. Product documentation and compliance data.
[4] Aenova Group. API sourcing and quality assurance reports.
[5] Hexion Chemicals. Supplier network and API portfolio overviews.