Bulk Pharmaceutical API Sources for PROPINE

Bulk Pharmaceutical API Sources for PROPINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		295493_ALDRICH
Sigma-Aldrich		480983_ALDRICH
NovoSeek		6335
NovoSeek		6432222
AAA Chemistry		AR-1C5570

Bulk Active Pharmaceutical Ingredient (API) Sources for PROPINE

Last updated: July 28, 2025

Introduction

Propine (hydroxyamphetamine sulfate) is a sympathomimetic agent primarily used as a mydriatic agent in ophthalmology to induce pupil dilation during diagnostic procedures. Its precise pharmacological profile, combined with its relatively niche use, influences the landscape of its bulk API sourcing. Understanding the available API manufacturers and suppliers is critical for pharmaceutical companies and distributors seeking reliable, compliant, and cost-effective sources to ensure the uninterrupted supply chain of Propine.

Overview of PROPINE and API Manufacturing

Propine's API, hydroxyamphetamine sulfate, is a synthetic sympathomimetic amine with stereospecific considerations. Its synthesis requires specific expertise in aromatic amino compounds, oxidation processes, and sulfate salt formation. The manufacturing process must adhere to Good Manufacturing Practices (GMP) to meet pharmaceutical standards.

The sourcing of hydroxyamphetamine sulfate involves multiple steps: phenylacetone derivative synthesis, nitration, reduction, and sulfation. Given its specialized synthesis pathway and regulatory controls, few manufacturers globally produce high-quality, GMP-compliant API for Propine.

Global API Manufacturers and Suppliers

1. Major Pharmaceutical API Producers

A limited number of pharmaceutical-grade API producers manufacture hydroxyamphetamine sulfate, often catering to both generic and branded formulations. Many of these suppliers operate under strict regulatory oversight, especially within regions such as Europe, North America, and Asia.

• Sun Pharmaceutical Industries Ltd. (India):
  Sun Pharma is among the leading producers of complex APIs, including derivatives of sympathomimetic amines. While their product catalog is extensive, specific data on hydroxyamphetamine sulfate as a standalone API is limited; however, they have a history of supplying specialty amine APIs.

• AstraZeneca (Sweden/Global):
  AstraZeneca has historically been involved in the synthesis of sympathomimetics, and some APIs derived from their portfolio are available through licensing agreements. However, current API supply details for Propine are proprietary.

• Pfizer (United States):
  Pfizer’s extensive API manufacturing capabilities include amine derivatives, but specific supply arrangements or stock of hydroxyamphetamine sulfate are not publicly disclosed.

• Hubei Topfond Pharmaceutical Co., Ltd (China):
  This company specializes in complex APIs, including sympathomimetics. They are known for large-scale manufacturing of phenethylamine derivatives, which could include hydroxyamphetamine sulfate. Their products are GSP (Good Supply Practices) certified, suitable for pharmaceutical use.

• Zhejiang Topfond Pharmaceutical Co. (China):
  An established supplier with a portfolio including various CNS-active compounds and sympathomimetics, potentially including hydroxyamphetamine sulfate, primarily serving Asian and global markets.

2. Contract Manufacturing Organizations (CMOs)

Several CMOs offer custom synthesis of hydroxyamphetamine sulfate, often catering to pharmaceutical companies requiring bulk APIs under strict regulatory compliance.

• Shanghai ChemPartner (China):
  Known for custom synthesis of complex APIs, including sympathomimetic compounds, with an emphasis on GMP compliance.

• Almac Group (UK):
  Offers bespoke synthesis for niche APIs, including research quantities of hydroxyamphetamine sulfate, with potential options for scale-up.

• Bachem (Switzerland):
  Specializes in peptide and amine synthesis, with capabilities to produce sympathomimetic API intermediates or the final API upon request.

3. Key Considerations for API Sourcing

• Regulatory Compliance:
  Providers must hold current GMP certifications, with traceability, purity, and validation data accessible for regulatory submissions.

• Quality Standards:
  Certificates of Analysis (CoA), stability data, and impurity profiles are essential to confirm API quality.

• Pricing and Lead Time:
  Given the niche nature of hydroxyamphetamine sulfate, prices can vary widely, influenced by scale, complexity, and regulatory status.

• Supply Security:
  Due to geopolitical and manufacturing risks, diversifying sources across regions can mitigate supply chain disruptions.

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Regional API Sources and Market Trends

North America

Major pharmaceutical companies like Pfizer and contract manufacturers in the U.S. focus on high-quality API production aligned with U.S. Pharmacopeia (USP) standards. However, specific hydroxyamphetamine sulfate APIs are limited and often sourced via Asia or Europe.

Europe

European suppliers tend to emphasize high regulatory standards, offering APIs verified for compliance with EMA guidelines. Bachem and similar firms provide custom synthesis services for niche APIs like Propine’s.

Asia

China and India dominate the API manufacturing landscape for niche and bulk APIs. Companies such as Zhejiang Topfond offer a cost-effective, compliant supply chain, with the caveat of varying regulatory oversight and quality assurance standards.

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Regulatory and Supply Chain Challenges

• Regulatory Barriers:
  The chemical synthesis of hydroxyamphetamine sulfate is controlled, and API producers must adhere to strict standards to meet international pharmaceutical regulations.

• Supply Chain Risks:
  The concentration of API production in certain regions introduces risks ranging from geopolitical issues to quality variability. Suppliers in China and India, while cost-effective, may face increased scrutiny, especially under updated U.S. and EU import regulations.

• Intellectual Property (IP) and Patent Considerations:
  While hydroxyamphetamine sulfate, as a generic compound, may not be patent-protected presently, sourcing from licensed suppliers ensures compliance and reduces legal risks.

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Future Outlook

The global API market for niche sympathomimetics like hydroxyamphetamine sulfate is expected to evolve with increased regulatory oversight and the drive for diversified supply chains post-pandemic. Advances in synthesis techniques may lead to local manufacturing in regulated markets, ensuring supply security and reducing dependency on overseas sources.

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Key Takeaways

• Sourcing Propine’s API involves navigating a limited market of specialized manufacturers and CMOs, predominantly located in Asia, Europe, and North America.
• Ensuring GMP compliance, high purity, and regulatory transparency is vital for sourcing hydroxyamphetamine sulfate API intended for pharmaceutical use.
• Regional supply chains carry distinct advantages and risks; diversification and rigorous supplier qualification are recommended.
• Contract manufacturing offers flexibility in scale-up and customization, accommodating evolving regulatory demands.
• The market is poised for consolidation, with increasing emphasis on quality assurance, regulatory compliance, and supply chain robustness.

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FAQs

1. Is hydroxyamphetamine sulfate readily available from multiple suppliers?
No, due to its niche application and complex synthesis, only a select group of specialized manufacturers and CMOs produce high-quality hydroxyamphetamine sulfate for pharmaceutical use.

2. What are the primary regions where Propine API can be sourced?
Mainly from Asia (China, India), Europe, and North America, with Chinese and Indian manufacturers dominating due to cost advantages and manufacturing scale.

3. What regulatory considerations should be considered when sourcing Propine API?
Suppliers should have GMP certification, comply with regional drug authorities (FDA, EMA, etc.), and provide comprehensive certification including Certificates of Analysis and impurity profiles.

4. Can I develop Propine in-house through custom synthesis?
While technically feasible, in-house synthesis requires significant expertise, infrastructure, and regulatory compliance capabilities. Partnering with experienced CMOs is generally recommended.

5. How can supply chain risks for Propine API be mitigated?
Diversify suppliers across regions, establish quality agreements, conduct routine audits, and consider alternative sourcing or local manufacturing options aligned with regulatory standards.

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References

[1] U.S. Pharmacopeia. (2022). USP Monographs for Amphetamines and Derivatives.
[2] European Medicines Agency. (2021). Guidelines on Good Manufacturing Practice for Medicinal Products.
[3] Pharmaceutical Technology. (2023). Synthesis and Manufacturing Challenges of Sympathomimetic APIs.
[4] Bachem. (2022). Custom API synthesis offerings.
[5] Chinese API Manufacturers Association. (2022). Annual Market Report.