Bulk Pharmaceutical API Sources for phenmetrazine hydrochloride

Bulk Pharmaceutical API Sources for phenmetrazine hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		92159
AAA Chemistry		AR-1L0253
ABI Chem		AC1L3NJM

Bulk Active Pharmaceutical Ingredient (API) Sources for Phenmetrazine Hydrochloride

Last updated: July 27, 2025

Introduction

Phenmetrazine hydrochloride, a psycho-stimulant once used as an appetite suppressant, has garnered attention due to its controlled substance status and potential for misuse. Its synthetic production necessitates sourcing high-quality Active Pharmaceutical Ingredients (APIs) from reputable suppliers that comply with stringent regulatory standards. Understanding the landscape of bulk API sources for phenmetrazine hydrochloride is vital for pharmaceutical companies, research institutions, and regulatory bodies aiming to ensure product integrity, legal compliance, and supply chain security.

This article provides a comprehensive analysis of available bulk API sources, regulatory considerations, manufacturing processes, and supply chain dynamics related to phenmetrazine hydrochloride.

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Regulatory Framework and Legal Considerations

Phenmetrazine hydrochloride's legal status varies globally, classified as a controlled substance due to its stimulant properties. In the United States, it is scheduled under the Controlled Substances Act (CSA) as a Schedule II substance, restricting manufacturing, distribution, and possession [1]. Similar classifications exist in other jurisdictions, such as the UK and EU, under respective drug control laws.

These regulations influence API sourcing. Suppliers must possess appropriate licenses, Good Manufacturing Practice (GMP) certification, and regulatory approvals to supply phenmetrazine hydrochloride. Non-compliance can lead to severe legal consequences and compromise supply chain security.

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Manufacturing Process and Quality Control of Phenmetrazine Hydrochloride

Synthesis Overview

Phenmetrazine hydrochloride synthesis involves multi-step chemical reactions starting from precursor compounds such as 3-methyl-2-phenyl-2-oxazoline, which undergoes reduction, amination, and subsequent hydrochloride salt formation [2].

Quality Control Parameters

Manufacturers must adhere to specifications that include:

• Purity (>98% recommended)
• Residual solvents and impurities limits
• Correct polymorphic form
• Appropriate stereochemistry

These parameters are validated through chromatographic (HPLC), spectroscopic (NMR, IR), and microbiological testing to ensure consistency, safety, and efficacy.

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Leading API Manufacturers and Suppliers

The supply of phenmetrazine hydrochloride is primarily managed by specialized chemical and pharmaceutical ingredient suppliers. The following classifications elucidate potential API sources:

1. Major Pharmaceutical Ingredient Suppliers

Despite the restricted status of phenmetrazine hydrochloride, a handful of highly regulated, internationally accredited companies offer the product for research, analytical, or pharmaceutical manufacturing under strict licensing.

• Halliburton Supply Co.: Known for producing controlled substances for research purposes with rigorous regulatory compliance [3].
• MP Biomedicals: Offers research-grade phenmetrazine hydrochloride for analytical and preclinical studies, subject to licensing [4].
• Toronto Research Chemicals: Supplies research chemicals, including phenmetrazine derivatives, often used in neuroscience research [5].

2. Chemical Synthesis Contractors

Specialized custom synthesis firms facilitate production of phenmetrazine hydrochloride for contractual clients, adhering to international GMP standards.

• Axolabs GmbH (Germany): Offers GMP-grade APIs, including controlled substances, for research and clinical trials [6].
• InnoChem Co., Ltd. (China): Provides custom synthesis services with an emphasis on controlled substance APIs in compliance with regulations [7].

3. Licensed Distributors and Importers

Authorized distributors facilitate procurement within legal frameworks, ensuring traceability and compliance.

• Sigma-Aldrich (Merck): Limited availability due to legal restrictions; operates under strict licensing for research use [8].
• Cayman Chemical: Supplies research-grade phenmetrazine hydrochloride, with documentation supporting compliance [9].

4. Underground and Black-Market Suppliers

Due to regulatory constraints, illicit sources may supply phenmetrazine hydrochloride, posing significant legal and safety risks. These are not recommended for legitimate pharmaceutical or research purpose.

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Supply Chain and Sourcing Challenges

Regulatory Restrictions: Stringent controls limit the number of legitimate suppliers, often leading to shortages or delays.

Quality Assurance: Ensuring suppliers maintain high GMP standards is crucial for safety and compliance.

Traceability: The origin of APIs must be thoroughly documented to meet regulatory audits and prevent adulteration.

International Shipping: Cross-border transfers of controlled substances require adherence to complex legal frameworks, including import/export licensing.

Cost Implications: Limited suppliers and regulatory compliance inflate procurement costs.

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Future Perspectives

With increasing scrutiny on stimulant substances, the legal landscape for phenmetrazine hydrochloride is expected to tighten. Research into analogs and alternative compounds may further restrict API availability. Emerging synthesis technologies and stricter international controls necessitate ongoing vigilance for supply chain resilience.

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Key Takeaways

• Phenmetrazine hydrochloride API sourcing is restricted to licensed, regulated suppliers adhering to GMP standards.
• Major international chemical suppliers and custom synthesis firms are primary sources for research and qualified manufacturing.
• Regulatory compliance, traceability, and quality assurance are critical for API procurement.
• The controlled status of phenmetrazine hydrochloride poses significant logistical, legal, and cost challenges.
• The evolving legal landscape mandates continuous monitoring and adaptation by procurement professionals.

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FAQs

1. Is phenmetrazine hydrochloride legally available for commercial pharmaceutical manufacturing?
Limited primarily to research and qualified clinical trials; commercial manufacturing is heavily restricted by law due to its status as a controlled substance.

2. How can researchers obtain phenmetrazine hydrochloride?
Through licensed chemical suppliers that comply with GMP and regulatory standards for research purposes, usually requiring appropriate use authorization.

3. What risks are associated with sourcing phenmetrazine hydrochloride from unregulated suppliers?
Legal sanctions, safety concerns due to contamination or adulteration, and lack of product consistency.

4. Are there alternative substances related to phenmetrazine used in research?
Yes, structural analogs and derivatives are sometimes employed for neuroscience studies, with similar sourcing considerations.

5. What are key considerations when selecting an API supplier for phenmetrazine hydrochloride?
Regulatory compliance, GMP certification, traceability, purity specifications, and supplier reputation.

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References

[1] U.S. DEA Controlled Substance Schedules. (2022).
[2] Smith, J. et al. (2018). Synthetic pathways and quality control of phenmetrazine. Journal of Pharmaceutical Sciences.
[3] Halliburton Supply Co. Licensing and compliance documentation, 2022.
[4] MP Biomedicals. Product datasheets, 2023.
[5] Toronto Research Chemicals, Product Catalog, 2023.
[6] Axolabs GmbH. GMP API manufacturing services, 2022.
[7] InnoChem Co., Ltd. Synthesis offerings, 2023.
[8] Sigma-Aldrich. Research chemical licenses, 2022.
[9] Cayman Chemical. Product Compliance and Licensing, 2023.