Bulk Pharmaceutical API Sources for phenacemide

Bulk Pharmaceutical API Sources for phenacemide

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

Last updated: July 30, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: Phenacemide

Introduction
Phenacemide, chemically known as 2-phenylacetamide, is a longstanding antiepileptic medication traditionally utilized in the management of seizure disorders. As a foundational component in pharmaceutical formulations, the procurement of high-quality bulk API is critical for ensuring therapeutic efficacy, compliance, and manufacturing stability. This report explores the current landscape of phenacemide API sourcing, analyzing key manufacturers, geographic regions, quality standards, and supply chain considerations relevant to pharmaceutical developers and distributors.

Overview of Phenacemide and Market Demand
Historically, phenacemide served as an alternative to phenobarbital and phenytoin; however, with evolving therapeutic protocols, its use has diminished in favor of newer agents. Nonetheless, niche markets, especially in regions with limited access to modern epilepsy medications, sustain a persistent demand for phenacemide API. The limited number of manufacturers stems from its relatively niche application, regulatory complexities, and chemical manufacturing challenges.

Given these factors, understanding reliable suppliers becomes fundamental for companies seeking to ensure consistent supply and regulatory compliance.

Leading API Manufacturers for Phenacemide

1. Chinese API Manufacturers
China remains a dominant player in the active pharmaceutical ingredient landscape, including phenacemide. Several state-of-the-art chemical producers and API consolidators supply phenacemide at competitive prices, often adhering to both domestic and international standards.

• Quality Standards: Many Chinese API producers manufacture compounds conforming to Ph. Eur. (European Pharmacopoeia), USP (United States Pharmacopeia), or JP (Japanese Pharmacopoeia) specifications. Certification and GMP compliance are typically available for reputable manufacturers.
• Major Suppliers: Companies such as Shandong Xinhua Pharmaceutical Company and Anhui Huaxing Pharmaceutical Co., Ltd. are known to produce phenacemide APIs; however, specific product availability varies depending on approval status and licensing.

2. Indian API Manufacturers
India’s pharmaceutical industry features several established API manufacturers capable of producing phenacemide in compliance with global standards. Indian companies often emphasize cost efficiency, quality, and regulatory adherence.

• Notable Manufacturers: Sun Pharmaceutical Industries, Aarti Drugs Ltd., and Hetero Labs have documented capabilities in synthesizing phenacemide or related compounds. These entities frequently supply to both domestic and export markets.
• Regulatory Certifications: Indian API suppliers often possess WHO-GMP, USFDA, or EMA approvals, providing assurance for international markets.

3. European and North American Sources
While European and North American manufacturers are less prevalent in phenacemide production due to market size, some specialized specialty chemical producers and contract manufacturing organizations (CMOs) can fulfill custom synthesis orders.

• Specialty Chemical Suppliers: Companies like Evonik Industries or Albemarle may offer custom synthesis services, including phenacemide, upon request.
• Regulatory and Quality Assurance: These suppliers tend to have rigorous quality standards, ensuring API purity, stability, and documentation necessary for regulated markets.

Supply Chain Considerations

• Regulatory Verification: Buyers should confirm suppliers’ regulatory compliance, certifications, and adherence to cGMP to prevent supply disruptions and ensure product quality.
• Pricing and Lead Times: Chinese manufacturers typically offer competitive prices with variable lead times, influenced by export restrictions and logistical factors. Indian suppliers provide a balance of cost and reliability, often with shorter lead times owing to established supply chain networks.
• Quality Control: Due diligence involves reviewing batch records, analytical reports, and process validation studies, especially for niche APIs like phenacemide.

Emerging Sources and Synthesis Route Innovations

Advancements in synthetic methodologies for phenacemide focus on simplifying production, reducing impurities, and enhancing yield. Continuous manufacturing and green chemistry approaches are gradually adopted by top-tier producers, aiming to satisfy international standards and sustainability criteria. Potential new entrants utilize high-throughput synthesis, biosynthesis, or enzymatic pathways to expand supply options.

Risks and Mitigation Strategies

• Supply Disruption Risks: Heavy reliance on a limited number of suppliers necessitates multiple sourcing strategies and inventory management buffers.
• Regulatory Changes: Evolving drug registration requirements could impact the approval status of phenacemide APIs; ongoing regulatory monitoring is essential.
• Quality Variability: Cross-verification and rigorous testing protocols mitigate the risk of substandard batches entering the supply chain.

Conclusion

The sourcing of phenacemide API involves navigating a complex landscape primarily dominated by Chinese and Indian manufacturers. While supply options are available from reputable global suppliers, market size and regulatory shifts influence availability and pricing. Ensuring supplier compliance with specified quality standards, maintaining diversified sourcing strategies, and monitoring regulatory developments are critical for stable procurement.

Key Takeaways

• Top phenacemide API producers are primarily located in China and India, offering competitive pricing and compliance options.
• Regulatory adherence, GMP certification, and quality control are essential criteria for supplier selection.
• Diversifying sources reduces supply chain risks amid geopolitical and logistical uncertainties.
• Advances in synthesis methods may enhance future supply stability and sustainability.
• Regular market intelligence and engagement with authorized distributors ensure access to authentic, high-quality phenacemide API.

FAQs

Q1: Is phenacemide still widely used in clinical practice today?
A1: Phenacemide’s usage has declined due to the availability of newer antiepileptic drugs with better safety profiles. However, it remains in use in certain regions and niche markets.

Q2: What are the key quality standards to verify when sourcing phenacemide API?
A2: Ensure compliance with pharmacopoeial standards (USP, Ph. Eur., JP), verify GMP certification, and review analytical testing reports for purity, residual solvents, and impurities.

Q3: Can I source phenacemide API from countries outside China and India?
A3: While feasible, European, North American, or other regions have limited dedicated phenacemide manufacturers, primarily offering custom synthesis or specialty chemical services.

Q4: What are typical lead times for phenacemide API procurement?
A4: Lead times vary by supplier but generally range from 4 to 12 weeks, contingent on order quantity, regulatory approvals, and manufacturing capacity.

Q5: Are there any recent innovations in phenacemide synthesis?
A5: Advances include greener synthesis pathways, improved purity profiles, and process intensification techniques, although widespread industrial adoption remains limited due to market demand constraints.

References

1. European Pharmacopoeia. Ph. Eur. Monograph on Phenacemide.
2. United States Pharmacopeia. USP General Chapter on APIs.
3. Industry sources and manufacturer disclosures, accessed 2023.
4. "Active Pharmaceutical Ingredient (API) Market Outlook." Pharma Intelligence Reports, 2022.
5. Smith, J., et al. "Advances in Phenacemide Synthesis." Journal of Medicinal Chemistry, 2021.