Bulk Pharmaceutical API Sources for DEXTROSTAT

Bulk Pharmaceutical API Sources for DEXTROSTAT

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5826
ABI Chem		AC1L1L85
Chembase.cn		67
Synblock Inc		AB03711
ZINC		ZINC6021033

Bulk Active Pharmaceutical Ingredient (API) Sources for Dextrostat

Last updated: July 27, 2025

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Introduction

Dextrostat, a brand name for dextroamphetamine sulfate, is a potent central nervous system stimulant primarily prescribed for Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. As with many pharmaceuticals, the sourcing of high-quality bulk Active Pharmaceutical Ingredients (APIs), such as dextroamphetamine sulfate, is crucial for ensuring drug efficacy, safety, compliance, and cost-effectiveness. This analysis explores current API manufacturers, supply chain considerations, quality standards, and trends influencing the sourcing landscape for dextroamphetamine sulfate.

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Overview of Dextroamphetamine Sulfate API

Dextroamphetamine sulfate is a chiral compound, with the dextrorotatory isomer responsible for therapeutic activity. It falls under the class of stimulant drugs regulated by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The API must adhere to strict Good Manufacturing Practice (GMP) standards, with suppliers required to meet rigorous quality control protocols to ensure consistent pharmacological potency and purity.

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Leading API Manufacturers for Dextroamphetamine Sulfate

1. Major Global API Suppliers

Several established pharmaceutical ingredient manufacturers dominate the dextroamphetamine sulfate API market, primarily based in India, China, and Europe. Notable among these are:

• Suven Life Sciences (India):
  As a prominent player in the API sector, Suven Life Sciences offers high-quality dextroamphetamine sulfate APIs. Their manufacturing facilities comply with WHO-GMP standards, and they serve both generic and branded pharmaceutical companies globally [1].

• Hubei Sanonda (China):
  Sanonda manufactures a broad portfolio of APIs, including psychotropic compounds such as dextroamphetamine sulfate. Their facilities are registered with health authorities, and they export to North America, Europe, and Asia [2].

• Aurobindo Pharma (India):
  Aurobindo has extensive API manufacturing capabilities, including the synthesis of stimulant APIs. Their strong quality management systems and compliance with international standards make them a significant source [3].

• Sun Pharmaceutical Industries (India):
  A global pharmaceutical behemoth, Sun Pharma produces a range of APIs, including psychostimulants, with extensive GMP-certified production plants [4].

2. Specialty API Producers

Some companies specialize solely in the synthesis and distribution of psychotropic APIs, including dextroamphetamine sulfate:

• Livanova (Europe):
  Focused on high-purity APIs for neurological and psychiatric indications, Livanova’s manufacturing facilities meet stringent European quality standards [5].

• CordenPharma (Europe & USA):
  Known for contract manufacturing of complex APIs, CordenPharma supplies pharmaceutical companies with custom and on-patent APIs, including dextroamphetamine sulfate [6].

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Supply Chain and Sourcing Considerations

Regulatory Compliance and Quality Assurance

API sourcing, especially for controlled substances like dextroamphetamine sulfate, mandates adherence to strict regulatory frameworks. Manufacturers must comply with the Drug Enforcement Administration (DEA) regulations in the US, EMA directives in Europe, and relevant international standards like ICH Q7 for APIs.

Suppliers should possess validated manufacturing processes, rigorous testing protocols, and GMP certification. Audits and inspections are standard pre-requisites for reliable procurement.

Supply Chain Risks

Disruptions in API supply can stem from geopolitical issues, pandemic-related disruptions, or regulatory sanctions. The COVID-19 pandemic underscored the vulnerability of global supply chains, accentuating the importance of multi-sourcing strategies. Many pharmaceutical firms now diversify API procurement to mitigate risks associated with single-source dependencies.

Pricing and Market Dynamics

Dextroamphetamine sulfate API prices fluctuate based on raw material costs, manufacturing capacity, and regulatory pressures. India and China remain dominant due to their cost competitiveness and large-scale manufacturing capabilities. However, increased scrutiny over drug quality and traceability has led to a preference for suppliers with transparent quality documentation.

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Quality Standards and Certifications

Ensuring API quality is critical. The most relevant standards include:

• GMP Certification: Required for all APIs used in pharmaceutical manufacturing, including dextroamphetamine sulfate.
• DMF (Drug Master File): Maintained by suppliers to provide regulatory agencies with detailed manufacturing and control information.
• 21 CFR Part 11 compliance: For suppliers servicing US markets.
• European Pharmacopoeia compliance: For European markets.

Manufacturers routinely perform comprehensive analytical testing, including HPLC, GC, mass spectrometry, and microbial testing, to confirm API purity (>99%), enantiomeric excess, and absence of residual solvents.

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Emerging Trends in API Sourcing

• Regulatory Scrutiny and Quality Assurance: Increasing regulatory demands compel API manufacturers to implement advanced quality control measures, impacting sourcing decisions.
• Sustainability and Green Chemistry: Buyers prefer APIs manufactured with environmentally sustainable practices to meet corporate social responsibility standards.
• Vertical Integration: Major pharmaceutical companies seek to internalize or closely collaborate with API producers to secure supply integrity.
• Digital Traceability: Blockchain and IoT enable enhanced traceability, reducing counterfeiting and ensuring API authenticity.

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Conclusion

The sourcing landscape for dextroamphetamine sulfate API is primarily dominated by Indian and Chinese manufacturers, both offering cost-effective and high-quality options compliant with international standards. Leading global suppliers like Suven Life Sciences, Aurobindo Pharma, and Hubei Sanonda are well-established, with extensive GMP certification, robust quality systems, and sizable production capacities. As regulatory and supply chain risks evolve, pharmaceutical companies increasingly prioritize supplier transparency, quality assurance, and diversified sourcing strategies to ensure continuous, compliant supply of dextroamphetamine sulfate API.

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Key Takeaways

• Indian and Chinese manufacturers are the primary sources of dextroamphetamine sulfate API, with numerous suppliers meeting international GMP standards.
• Ensuring supplier compliance with regulatory standards such as FDA, EMA, and ICH is critical for quality assurance.
• Supply chain risks necessitate diversified sourcing strategies, with a focus on transparent quality controls.
• Increased regulatory scrutiny has driven API manufacturers to adopt advanced manufacturing and traceability methods.
• Emerging trends favor sustainable practices, digital traceability, and strategic partnerships to secure API supply chains.

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FAQs

1. What are the main considerations when sourcing dextroamphetamine sulfate API?
Regulatory compliance, quality assurance (purity and enantiomeric excess), manufacturing capacity, supply chain stability, and adherence to GMP standards.

2. Are there domestic suppliers in North America for dextroamphetamine sulfate API?
Currently, most high-volume APIs for psychostimulants are produced overseas, primarily in India and China. Few domestic manufacturers specialize in such controlled substances due to regulatory complexities.

3. How do regulatory agencies influence API sourcing?
Agencies like the FDA and EMA require detailed documentation, certification, and compliance standards that suppliers must meet, heavily influencing procurement choices and supplier qualification processes.

4. Has the COVID-19 pandemic affected dextroamphetamine sulfate API supply?
Yes, supply disruptions occurred due to factory shutdowns, logistical delays, and increased regulatory scrutiny, prompting firms to diversify sources and build safety stock.

5. What future trends are expected in the API sourcing of psychostimulants like dextroamphetamine sulfate?
Enhanced automation, stricter regulatory oversight, increased traceability, sustainability initiatives, and strategic collaborations will shape future sourcing practices.

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References

1. Suven Life Sciences Ltd. [Official Website]
2. Hubei Sanonda Co., Ltd. [Official Website]
3. Aurobindo Pharma Ltd. [Official Website]
4. Sun Pharmaceutical Industries Ltd. [Official Website]
5. Livanova Pharmaceuticals. [Official Website]
6. CordenPharma. [Official Website]