Bulk Pharmaceutical API Sources for ORNIDYL

Bulk Pharmaceutical API Sources for ORNIDYL

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-006-169-327
AKos Consulting & Solutions		AKOS006281180
Finetech Industry Limited		FT-0630795
Amadis Chemical		204965

Bulk Active Pharmaceutical Ingredient (API) Sources for Ornidyl (Piracetam)

Last updated: July 28, 2025

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Introduction

Ornidyl, the proprietary name for Piracetam, is a nootropic compound used primarily to treat cognitive impairments, including dementia and cognitive decline associated with aging and neurological disorders. As with other pharmaceuticals, the availability and sourcing of high-quality Bulk Active Pharmaceutical Ingredients (API) are crucial for manufacturing, regulatory compliance, and ensuring drug efficacy and safety. This report delineates the global API landscape for Piracetam, emphasizing reputable sources, manufacturing hubs, and supply chain considerations relevant to Ornidyl production.

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Understanding Piracetam and Its Regulatory Context

Piracetam, chemically known as 2-oxo-1-pyrrolidineacetam, was developed in the 1960s by Dr. Cornelius Rhoads at UCB Pharma. The compound received regulatory approval in several countries for specific neurological conditions. However, in many markets such as the US, it remains off-label and unapproved as a pharmaceutical. Its API sourcing environment is consequently complex, influenced by varying regulatory standards, supplier credibility, and manufacturing capabilities.

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Global API Production Landscape for Piracetam

1. Leading API Manufacturing Countries

China

China remains the dominant global hub for bulk API production, including piracetam. Many Chinese pharmaceutical ingredient suppliers are well-established, offering bulk quantities of piracetam to international markets. Key industry players often operate under Good Manufacturing Practices (GMP) standards aligned with EU and US requirements, although due diligence is mandated to verify certification compliance.

India

India is a significant player in pharmaceutical manufacturing, including generic and active pharmaceutical ingredients like piracetam. Several Indian API manufacturers have achieved WHO-GMP, ISO certifications, providing quality assurance to global clients. Indian suppliers often offer competitive pricing and reliable supply chains, especially for medications with existing regulatory approvals.

Europe

While smaller in scale compared to China and India, Europe produces piracetam APIs through specialized chemical and pharmaceutical manufacturers. Companies such as SIFI (Italy) and some smaller European firms provide high-quality, GMP-compliant APIs with robust quality documentation intended for markets with stringent regulatory standards.

United States

U.S.-based API production for piracetam is limited, primarily due to regulatory constraints and the off-label status of the drug. Some US-based chemical suppliers produce piracetam for research and development purposes, but commercial API manufacturing is scarce and highly regulated.

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2. Key API Suppliers and Manufacturers

Chinese Suppliers

• Zheijiang Huajing Pharmaceutical Co., Ltd. – Offers piracetam API batches compliant with international standards; known for large-volume exports.
• Shandong Dawei Pharmaceutical Co., Ltd. – Provides GMP-certified piracetam APIs with competitive pricing.
• Hunan NutraMax Inc. – Supplier of pharmaceutical intermediates and APIs, including piracetam, exporting globally.

Indian Suppliers

• Linhai Anxin Chemical Co., Ltd. – Supplies piracetam API with certifications suitable for export markets.
• Glenmark Pharmaceuticals – Some divisions manufacture APIs for internal use and export, with strict adherence to GMP.
• Aarti Chemicals Ltd. – Offers high-grade piracetam API, targeting international clients with compliance documentation.

European and Other Suppliers

• SIFI S.p.A (Italy) – Specializes in nootropics and provides high-purity piracetam API for pharmaceutical companies.
• Spectra Chemicals (UK) – Offers specialty chemicals and APIs, including piracetam, with comprehensive quality certification.

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Supply Chain and Quality Considerations

Stricter Regulatory Standards:
For markets such as Europe and the US, suppliers must demonstrate compliance with GMP, DMF (Drug Master File) registration, and ISO standards. Buyers should scrutinize Certificates of Analysis (CoA), Good Manufacturing Practices certification, and third-party audits.

Certifications and Documentation:
Reliable suppliers typically provide detailed documentation, including batch records, stability data, and purity profiles, ensuring traceability and regulatory acceptance.

Pricing and Lead Times:
Chinese manufacturers often offer the most competitive prices, with lead times ranging from 4-12 weeks, depending on order volume and regulatory clearance. Indian suppliers also provide timely delivery, with pricing slightly higher but often matched by superior documentation and reliability.

Risks and Due Diligence:
Potential risks include counterfeit APIs, inconsistent quality, and regulatory non-compliance. Engaging with suppliers holding recognized certifications and undergoing site audits mitigates these risks.

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Market Trends and Future Outlook

The API sourcing landscape for piracetam is influenced by regulatory shifts, market demand, and manufacturing innovations:

• Regulatory Trends: The increasing scrutiny of bulk API sourcing, especially amid globalization, underscores the importance of regulatory compliance. Authorities like the EMA, FDA, and WHO stipulate high standards for API quality.

• Supply Chain Resilience: COVID-19 highlighted vulnerabilities in API supply chains, prompting manufacturers to diversify sourcing strategies and develop local manufacturing capacities.

• Emerging Manufacturers: Small-to-medium enterprises (SMEs) in Southeast Asia and Eastern Europe are increasingly entering the market, offering competition and supplementary options for API procurement.

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Implications for Ornidyl (Piracetam) Manufacturers

Manufacturers contemplating API acquisitions should prioritize suppliers with verified GMP certification, transparent quality assurance processes, and robust supply chain logistics. Long-term relationships with reputable vendors can ensure steady supply, regulatory compliance, and cost-effectiveness. A comprehensive supplier audit is recommended prior to committing to large-scale procurement.

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Key Takeaways

• China and India dominate the global piracetam API market, offering volume, cost-effectiveness, and extensive supplier networks.
• European suppliers provide high-grade, GMP-compliant APIs suitable for regulated markets.
• Due diligence is essential—verify certifications, conduct audits, and review quality documentation before procurement.
• Supply chain resilience is increasingly critical, prompting diversification and strategic partnerships.
• Regulatory compliance continues to shape API sourcing, emphasizing the importance of certification and traceability.

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FAQs

Q1: What certifications should I verify when sourcing piracetam API?
A: Ensure suppliers hold GMP certification, proper ISO certifications, and provide Certificates of Analysis (CoA), including purity, potency, and stability data.

Q2: Are Chinese piracetam APIs as reliable as European or Indian sources?
A: Many Chinese suppliers meet international GMP standards; however, thorough due diligence and audits are advised to verify compliance and quality.

Q3: How does API purity impact Ornidyl manufacturing?
A: High-purity APIs reduce the risk of impurities, ensuring safety, efficacy, and regulatory compliance, which is critical in pharmaceutical production.

Q4: What are potential risks in API sourcing for piracetam?
A: Risks include counterfeit APIs, inconsistent quality, delayed supply, and non-compliance with regulatory standards. Vetting suppliers mitigates these issues.

Q5: How is the demand for piracetam API expected to evolve?
A: Growing interest in cognitive health, coupled with regulatory monitoring, suggests steady demand; however, competing compounds and market restrictions may influence future supply dynamics.

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Sources

1. [1] European Medicines Agency. Guidelines on Good Manufacturing Practices. EMA, 2022.
2. [2] World Health Organization. Prequalification of Pharmaceuticals. WHO, 2023.
3. [3] Chinese Pharmacopoeia Commission. Standards for Pharmaceutical Ingredients. Chinese Pharmacopoeia, 2021.
4. [4] Indian Pharmacopoeia Commission. API Source Guidelines. Pharmacopeia of India, 2022.
5. [5] Industry Reports. Market Analysis of Global API Suppliers. PharmaTech Reports, 2023.