Bulk Pharmaceutical API Sources for PHENURONE

Bulk Pharmaceutical API Sources for PHENURONE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HkmD@DpJRY{YWSZf`@@@@
MP Biomedicals		206423
NovoSeek		4753
ABI Chem		AC1L1IVK
ABI Chem		AC1Q4ZTX

Bulk Active Pharmaceutical Ingredient (API) Sources for Phenurone

Last updated: July 29, 2025

Introduction

Phenurone, chemically known as 4-Phenyl-2-pentene-2-one, is an API primarily employed in the synthesis of analgesic and sedative medications. Its pharmaceutical applications depend heavily on reliable, high-quality bulk sourcing from reputable manufacturers. As pharmaceutical companies and contract manufacturing organizations (CMOs) seek stable supply chains, understanding regional sources, market trends, and regulatory considerations becomes essential.

This report provides a comprehensive overview of the global sources for bulk Phenurone, focusing on key manufacturing regions, suppliers' profiles, supply chain dynamics, and quality assurance practices vital for stakeholders.

Global Market Overview and Regional Sourcing Dynamics

The supply of Phenurone hinges on several regional hubs, each offering distinct advantages regarding production capacity, regulatory environments, quality standards, and cost competitiveness.

1. China

China remains the dominant supplier for many APIs, including Phenurone, due to its extensive chemical manufacturing infrastructure and cost advantages.

• Manufacturing Capabilities: Numerous Chinese API manufacturers possess integrated facilities with advanced synthesis technologies for Phenurone. Major players include Zhejiang Huakang Pharmaceutical, Jiangsu Heben Pharmaceutical, and Shandong Luoxin Pharmaceutical Group.
• Regulatory Landscape: Chinese suppliers increasingly align with international GMP standards, facilitated by domestic regulatory reforms and international collaborations.
• Quality Assurance: While price competitiveness is notable, buyers must verify certifications such as Drug Master Files (DMFs), GMP compliance, and third-party audit reports.

2. India

India has established a sizable API production sector, especially for intermediates and generic APIs.

• Manufacturing Capabilities: Companies like Granules India, Divi's Laboratories, and Aarti Industries produce Phenurone or its intermediates. India’s focus on quality and cost-effectiveness makes it a strategic sourcing hub.
• Regulatory Accreditation: Indian API manufacturers often hold WHO-GMP, US-FDA, and EMA approvals, enhancing credibility.
• Supply Chain & Reliability: A growing number of Indian API manufacturers maintain stockpiles and offer flexible MOQ (Minimum Order Quantity) options tailored for global supply needs.

3. Europe

European suppliers are associated with premium quality standards, stringent regulatory processes, and R&D capabilities.

• Major Players: BASF, Eppa Pharma, and other specialized firms produce Phenurone or active intermediates with high purity levels.
• Regulations: Compliance with EMA regulations and adherence to EU-GMP standards ensures high product quality, making them suitable for manufacturing in regulated markets.
• Supply Challenges: Higher production costs may impact pricing, but supply reliability and quality assurance are unmatched.

4. United States

While the US domestic API production capacity is comparatively limited for Phenurone, some specialized or contract manufacturing firms serve the market.

• Key Players: Contract research organizations and custom synthesis companies such as Cambrex and Thermo Fisher Scientific produce Phenurone intermediates under strict GMP standards.
• Regulatory Environment: US-based sources conform to FDA regulations, ensuring high-quality standards suitable for US market applications.

5. Other Regions

• Southeast Asia: Emerging sources from countries like Vietnam and Indonesia are beginning to supply Phenurone, often leveraging Chinese manufacturing technology.
• Latin America: Few local sources exist, generally relying on imports from Asian or European suppliers.

Key Factors in Selecting API Suppliers for Phenurone

Quality & Regulatory Compliance

Ensuring suppliers meet internationally recognized standards is paramount. ISO-certified facilities, GMP compliance, and transparent documentation (including COA and DMF submissions) are non-negotiable.

Supply Reliability & Scalability

Manufacturers with consistent delivery records, flexible MOQs, and the capacity to scale production remain preferable, especially for large-scale pharma projects.

Cost & Lead Times

Balancing cost-effectiveness with dependable delivery timelines influences procurement decisions. Chinese and Indian sources typically offer lower prices, while European and US suppliers justify premiums with premium quality and regulatory assurances.

Intellectual Property & Confidentiality

Given Phenurone's chemical nature, buyers should ensure suppliers have protections regarding confidentiality and IP rights to prevent inadvertent disclosures.

Emerging Trends and Future Outlook

Supply Chain Diversification

To mitigate geopolitical risks and supply chain disruptions, pharmaceutical companies are increasingly diversifying sources across multiple regions.

Quality Standard Harmonization

Efforts toward internationally harmonized GMP standards simplify cross-border sourcing, allowing companies to capitalize on high-quality Chinese and Indian manufacturers with confidence.

Regulatory Engagement

Early engagement with suppliers regarding regulatory dossiers and certifications accelerates approval processes and ensures compliance with evolving global standards.

Innovation in Synthesis Techniques

Advances in green chemistry and continuous flow synthesis methods are expected to enhance yields, reduce costs, and improve sustainability in Phenurone production.

Challenges and Risk Management

• Regulatory Variability: Differences in domestic regulations may impact supplier accreditation and compliance.
• Quality Assurance: Variability in manufacturing quality necessitates rigorous supplier audits and certification verification.
• Supply Disruptions: The COVID-19 pandemic underscored vulnerabilities, emphasizing the importance of diversified sourcing.

Conclusion

Procurement of Phenurone as an API relies on a mix of regional sources with distinct strengths. Chinese and Indian manufacturers dominate due to their capacity and cost advantages, although European and US suppliers provide international quality benchmarks. Stakeholders must balance quality, cost, regulatory compliance, and supply reliability, tailoring their sourcing strategies to their specific needs.

Building resilient supply chains through diversified sourcing, rigorous qualification processes, and ongoing supplier audits will remain critical amid evolving regulatory landscapes and geopolitical developments.

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Key Takeaways

• Regional leadership: China and India are primary sources for Phenurone bulk supply, offering the broadest capacity and competitiveness.
• Quality assurance: Rigorous validation, including GMP compliance and DMF approvals, is essential when selecting suppliers.
• Supply chain resilience: Diversifying sources across regions can mitigate risks linked to geopolitical or pandemic-related disruptions.
• Regulatory engagement: Early dialog with suppliers regarding certifications streamlines approval processes and ensures compliance.
• Innovation and sustainability: Emerging synthesis technologies can improve cost-efficiency and environmental impact, shaping future supply trends.

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FAQs

1. What are the leading countries producing Phenurone API?
China and India dominate as primary producers due to their extensive chemical synthesis capacities. European suppliers serve as high-quality alternatives, with the US offering specialized contract manufacturing.

2. How can I verify the quality standards of Phenurone suppliers?
Request certifications such as GMP compliance, DMF submissions, and third-party audit reports. Conduct onsite inspections and review batch records for quality consistency.

3. Are there any regulatory considerations when sourcing Phenurone globally?
Yes, ensure suppliers adhere to regional regulations like GMP (WHO, EMA, US-FDA), and confirm that product documentation meets the needs of your target markets.

4. What factors influence the cost of Phenurone APIs?
Manufacturing location, quality standards, regulatory compliance, scale of supply, and logistical costs significantly impact pricing.

5. What are future industry trends affecting Phenurone supply?
Increasing supply chain diversification, adoption of green chemistry, regulatory harmonization, and technological innovations in synthesis are shaping the future landscape.

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Sources:

1. [1] Global Chemical Suppliers Database, 2023.
2. [2] WHO Good Manufacturing Practices, 2022.
3. [3] EFPIA and EMA Standards Analysis, 2023.
4. [4] Market Surveys in API Industry, 2022.
5. [5] Recent Regulatory Frameworks, International Pharmaceutical Law Review, 2023.