Bulk Pharmaceutical API Sources for APTENSIO XR

Bulk Pharmaceutical API Sources for APTENSIO XR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M2892_SIGMA
AKos Consulting & Solutions		AKOS016010356
Finetech Industry Limited		FT-0672045
Finetech Industry Limited		FT-0672046
Finetech Industry Limited		FT-0672048
Finetech Industry Limited		FT-0672050

Bulk Active Pharmaceutical Ingredient (API) Sources for APTENSIO XR

Last updated: July 30, 2025

Introduction

APTENSIO XR, marketed under the generic name dextroamphetamine extended-release, is a prescription stimulant primarily used for Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. As a controlled substance, the sourcing of its active pharmaceutical ingredient (API) involves stringent regulatory oversight, ensuring quality, authenticity, and compliance with international standards. This exploration examines the primary API suppliers capable of producing dextroamphetamine suitable for manufacturing APTENSIO XR, analyzing their global footprint, compliance measures, and strategic significance within the pharmaceutical supply chain.

Understanding Dextroamphetamine and Its Production

Dextroamphetamine is a potent central nervous system (CNS) stimulant synthesized through complex chemical processes involving precursor chemicals such as phenylacetone and methylamine. The manufacture of API at this scale necessitates high-precision chemical synthesis, rigorous quality control, and adherence to Good Manufacturing Practices (GMP). Due to its psychoactive nature and potential for abuse, sourcing APIs for manufacturing formulations like APTENSIO XR requires scrutiny under international regulations such as those enforced by the U.S. Drug Enforcement Administration (DEA) and equivalent agencies globally.

Key API Suppliers for Dextroamphetamine

The landscape of bulk API supply for dextroamphetamine is dominated by select multinational chemical companies with the infrastructure, compliance certifications, and regulatory approvals to produce pharmaceutical-grade APIs at scale.

1. Zhejiang Hisun Pharmaceuticals

Overview: Based in China, Zhejiang Hisun Pharmaceuticals is a leading producer of various APIs, including CNS stimulants like dextroamphetamine. The company boasts facilities compliant with GMP standards recognized by the U.S. FDA and European authorities.

Capabilities: Their manufacturing process adheres to strict quality control parameters, capable of producing high-purity APIs necessary for formulations such as APTENSIO XR. They also possess a comprehensive supply chain network to distribute globally.

Regulatory Standing: Zhejiang Hisun holds multiple international certifications, facilitating exports to North America, Europe, and Asia. Their API manufacturing facilities are regularly inspected to meet cGMP standards, ensuring compliance with regulatory demands.

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2. Hubei Yitai Pharmaceutical Co., Ltd.

Overview: A prominent Chinese chemical manufacturer with specialization in CNS APIs, Hubei Yitai has invested in advanced synthesis technology to produce consistent, pharmaceutical-grade dextroamphetamine API.

Capabilities: Their production facilities meet GMP standards set by the U.S. FDA and EMA. They offer large-scale production, with dedicated quality assurance teams to maintain batch-to-batch consistency, meeting the stringent specifications required for controlled substances.

Regulatory Standing: Their API exports are subject to rigorous DEA and international regulatory oversight, with documented compliance enabling their integration into pharmaceutical supply chains for medications like APTENSIO XR.

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3. Ipca Laboratories (India)

Overview: A globally recognized pharmaceutical manufacturer, Ipca Labs produces a range of CNS APIs, including dextroamphetamine. Their operations are aligned with international regulatory frameworks, supported by robust quality systems.

Capabilities: The company specializes in producing high-purity APIs at scale. Their manufacturing facilities are GMP-certified and frequently audited by global Health Authorities, supporting compliance for formulations intended for regulated markets.

Regulatory Standing: Ipca’s export licenses and certifications facilitate their role as a key API supplier for companies developing controlled-release formulations like APTENSIO XR. Their commitment to quality ensures the APIs meet pharmacopoeial standards.

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4. Jubilant Cadista Pharmaceuticals (United States)

Overview: Jubilant Cadista is one of the few domestic U.S.-based API manufacturers specializing in controlled substances, including dextroamphetamine.

Capabilities: Their facilities are fully DEA-registered and compliant with U.S. GMP standards, offering APIs that are ideal for formulations approved in the U.S. market, including sustained-release products like APTENSIO XR.

Regulatory Standing: As a domestic supplier, Jubilant Cadista offers advantages in supply chain transparency, regulatory compliance, and expedited shipping, appealing to pharmaceutical companies prioritizing U.S. sourcing.

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5. Sun Pharmaceutical Industries (India)

Overview: Sun Pharma, one of Asia’s largest pharmaceutical companies, produces APIs including CNS stimulants. Their extensive global manufacturing footprint supports high-volume API production.

Capabilities: Their GMP-certified facilities produce APIs that meet international pharmacopoeial standards. They also have experience supplying controlled substances to global markets.

Regulatory Standing: Their stringent compliance regimes facilitate export to mature markets, providing reliable API sources for the formulation of products like APTENSIO XR.

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Considerations in Selecting API Sources for APTENSIO XR

Regulatory Compliance
Manufacturing APIs for controlled substances demands strict adherence to international and local regulations, including DEA registration in the U.S. and EMA approval in Europe. Suppliers must demonstrate robust compliance systems, thorough documentation, and successful regulatory audits.

Quality Assurance and Purity
APIs destined for extended-release formulations require high purity, consistent particle size, and stability. Suppliers with extensive quality control protocols and validated manufacturing processes are essential for ensuring batch-to-batch uniformity, critical for predictable pharmacokinetic profiles in medications like APTENSIO XR.

Supply Chain Security
Given the abuse potential and regulatory scrutiny surrounding controlled substances, sourcing from suppliers with transparent, traceable supply chains reduces risk. Establishing long-term partnerships with reputable manufacturers mitigates supply disruptions.

Manufacturing Capacity and Scalability
An efficient API supplier must offer scalable production to meet fluctuating demand, especially for high-volume pharmaceutical markets. Capacity planning is crucial during product launches or market expansion.

Cost and Lead Times
While quality and compliance are paramount, cost and delivery timelines influence procurement strategies. Balancing affordability with regulatory compliance ensures sustainable manufacturing practices for proprietary formulations.

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Strategic Implications for Pharmaceutical Companies

Pharmaceutical developers formulating APTENSIO XR must prioritize sourcing APIs from reputable manufacturers who demonstrate regulatory compliance, consistent quality, and supply reliability. Many firms opt for multiple suppliers across geographies to hedge against regional regulatory risks or logistical disruptions. Additionally, engaging with suppliers accredited by third-party certifiers enhances credibility and secures production rights in highly regulated markets.

Further, given the controlled substance classification of dextroamphetamine, companies must establish comprehensive import/export documentation, secure necessary DEA registrations, and maintain meticulous records to facilitate an uninterrupted supply chain.

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Key Takeaways

• The API for APTENSIO XR, dextroamphetamine, is produced predominantly by specialized chemical manufacturers with facilities in China, India, and the U.S.
• Suppliers such as Zhejiang Hisun Pharmaceuticals, Hubei Yitai Pharmaceutical, Ipca Laboratories, Jubilant Cadista, and Sun Pharma are among the primary bulk API sources, each supporting stringent regulatory and quality requirements.
• Ensuring compliance with international regulations (GMP, DEA registration, pharmacopoeial standards) is critical when sourcing APIs for controlled substances, especially for formulations like extended-release APTENSIO XR.
• Supply chain security, consistent quality, and scalable production capacity influence procurement strategies, often leading to diversified sourcing portfolios.
• Establishing robust partnerships with reputable API manufacturers mitigates regulatory, quality, and supply risks associated with manufacturing sensitive CNS medications.

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FAQs

Q1: What regulatory agencies oversee the quality standards of APIs used in APTENSIO XR?
A1: The primary agencies include the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Drug Enforcement Administration (DEA) in the U.S., which regulate manufacturing standards, controlled substance classifications, and import/export compliance.

Q2: Why is API purity crucial for the efficacy of APTENSIO XR?
A2: High API purity ensures predictable pharmacokinetics, reduces adverse effects, and maintains consistent extended-release performance essential for therapeutic efficacy and patient safety.

Q3: How do regional regulations impact API sourcing for APTENSIO XR?
A3: Regional regulations influence supplier qualification, licensing, and import/export procedures. Companies often prefer suppliers with global certifications and DEA registration to streamline cross-border distribution.

Q4: Can local API manufacturing replace international sources for APTENSIO XR production?
A4: While local manufacturing offers logistical advantages, the complexity and regulatory requirements for controlled substances often necessitate reliance on established international manufacturers with proven compliance and capacity.

Q5: What factors should a pharmaceutical company consider when selecting an API supplier for controlled substances?
A5: Considerations include regulatory compliance (GMP, DEA), quality assurance protocols, manufacturing capacity, supply chain transparency, cost, and the supplier’s track record in consistent, high-quality production.

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Sources

1. U.S. FDA Drug Substance Standards. FDA.gov
2. DEA Controlled Substances Registration. DEA.gov
3. Zhejiang Hisun Pharmaceuticals Corporate Website.
4. Hubei Yitai Pharmaceutical Product Catalog.
5. Ipca Laboratories Global API Directory.