Bulk Pharmaceutical API Sources for OXYCET

Bulk Pharmaceutical API Sources for OXYCET

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-7C04153
RR Scientific		R6253672
RR Scientific		R6319621

Bulk Active Pharmaceutical Ingredient (API) Sources for OXYCET

Last updated: November 22, 2025

Introduction

OXYCET, a brand name for oxycodone combined with acetaminophen, is a potent opioid analgesic prescribed primarily for moderate to severe pain. Its efficacy hinges on the quality and integrity of the active pharmaceutical ingredient (API), specifically oxycodone. Ensuring a reliable, compliant, and high-quality supply chain for oxycodone API is crucial for pharmaceutical manufacturers, distributors, and regulators. This article explores the landscape of bulk API sourcing for OXYCET, highlighting key suppliers, sourcing considerations, regulatory compliance, and industry trends to inform stakeholders in the pharmaceutical supply chain.

Understanding OXYCET and Its API

OXYCET contains oxycodone as its active ingredient, classified as a Schedule II controlled substance in many jurisdictions due to its high potential for abuse and dependency. The API, oxycodone hydrochloride, must comply with stringent manufacturing standards, including Good Manufacturing Practice (GMP), and adhere to specific quality specifications, such as potency, purity, and impurity profiles.

Global API Production and Key Suppliers for Oxycodone

Major API Manufacturing Countries

The primary sources of oxycodone API are concentrated in countries with well-established pharmaceutical manufacturing infrastructure. These include:

• India: Known for its extensive API manufacturing sector, India supplies approximately 60% of the world's generic APIs. Major Indian API producers such as Sun Pharmaceutical Industries, Cadila Healthcare, and Dr. Reddy’s Laboratories manufacture oxycodone API to meet global demand, including for controlled substances like oxycodone.

• China: China is a significant API producer, known for its large-scale manufacturing capabilities, competitive pricing, and comprehensive GMP compliance. Companies such as Zhejiang Huahai Pharmaceutical and Zhejiang NHU Company are notable API suppliers in this region.

• Europe and North America: While production is fewer in number, some European and North American pharmaceutical companies produce high-quality APIs for regulatory compliance reasons, often for domestic use or specialized markets.

Leading API Suppliers for Oxycodone

Supplier	Location	Notable Features	Certification & Compliance
Sun Pharmaceuticals	India	Large-scale API manufacturing, extensive GMP	GMP, ISO, Drug Master File (DMF) registered
Dr. Reddy’s Laboratories	India	Focus on quality, competitive pricing	GMP, strict regulatory adherence
Zhejiang Huahai Pharma	China	Advanced manufacturing facilities, cost-effective	GMP, compliant with global standards
Zhejiang NHU	China	Integrated R&D, high purity API production	GMP, certification for global markets

Regulatory Considerations

Due to oxycodone's status as a controlled substance, API sourcing involves compliance with several regulations:

• DEA Registration (USA): Suppliers mustRegister with the Drug Enforcement Administration (DEA) for controlled substance manufacturing and distribution.

• Import/Export Regulations: International shipments require adherence to export control laws, including the International Narcotics Control Board (INCB) guidelines.

• GMP Compliance: Suppliers must maintain GMP standards per the World Health Organization (WHO) and local regulatory authorities.

Challenges in Sourcing Oxycodone API

• Regulatory Barriers: Stringent controls, licensing, and registration processes complicate sourcing, especially for international buyers.

• Supply Chain Security: There is increased scrutiny to prevent diversion and illicit distribution, demanding transparency and traceability in the supply chain.

• Quality Assurance: Low impurity profiles and consistent potency are critical for patient safety and regulatory approval.

• Price Fluctuations: Volatility in raw material costs, manufacturing expenses, and compliance burdens can impact pricing.

Emerging Trends in API Sourcing

Enhanced Regulatory Oversight

Global regulators, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have intensified oversight of controlled substance APIs. Manufacturers are increasingly required to provide detailed supply chain documentation and batch traceability.

Supply Chain Diversification

To mitigate risks associated with geographic or supplier dependency, pharmaceutical companies are diversifying their API sources. Manufacturers seek multiple approved suppliers for oxycodone API to ensure consistent supply and regulatory compliance.

Technological Innovations

Advancements such as continuous manufacturing and digital supply chain transparency tools are improving API quality, traceability, and fraud prevention.

Sustainability Considerations

Sustainable manufacturing practices and environmental regulations are influencing API suppliers to adopt greener processes, reduce waste, and minimize environmental impact.

Implications for Stakeholders

• Manufacturers: Must conduct rigorous supplier qualification, establish robust quality agreements, and verify compliance via inspection and documentation.

• Distributors: Require thorough due diligence and traceability mechanisms to fulfill legal and quality assurance obligations.

• Regulators: Emphasize transparency, licensing, and strict adherence to controlled substance regulations across borders.

• End-Users: Benefit from high-quality, compliant APIs through minimized risks of substandard or contaminated products.

Conclusion

Bulk sourcing of oxycodone API for OXYCET involves navigating a complex landscape of global manufacturing hubs, regulatory requirements, quality standards, and supply chain security. India and China dominate as primary suppliers, offering cost-effective and high-capacity manufacturing, provided compliance with international GMP and controlled substance regulations. As regulatory scrutiny increases, industry players must prioritize transparency, diversification, and quality assurance. Stakeholders committed to integrating these principles will better manage risks, ensure regulatory compliance, and uphold patient safety.

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Key Takeaways

• The primary sources of oxycodone API are India and China, both equipped with large-scale GMP-certified manufacturing facilities.
• Regulatory compliance, including DEA registration and international narcotics norms, is critical in API sourcing for controlled substances.
• Diversification of API suppliers and adoption of technological innovations are essential strategies to mitigate supply chain vulnerabilities.
• Increasing regulatory scrutiny demands rigorous documentation, quality assurance, and traceability throughout the supply chain.
• Sustainable manufacturing practices and environmental considerations are becoming integral to API supplier evaluation.

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FAQs

1. What are the main factors to consider when sourcing oxycodone API?
Manufacturers should evaluate supplier GMP compliance, regulatory registration, consistent quality, supply reliability, pricing, and traceability to ensure regulatory adherence and patient safety.

2. Are there alternative sources for oxycodone API outside India and China?
While India and China dominate due to scale and cost advantages, some European manufacturers produce high-quality oxycodone API, primarily for regional markets, but such options are limited.

3. How does regulatory oversight impact API sourcing for controlled substances?
Regulatory agencies enforce strict licensing, documentation, and compliance protocols, which can complicate sourcing and require rigorous supplier qualification and continuous audits.

4. What risks are associated with sourcing from unverified suppliers?
Risks include substandard quality, contamination, supply disruptions, legal violations, and potential diversion, all of which jeopardize patient safety and regulatory compliance.

5. How can pharmaceutical companies ensure a secure supply of oxycodone API?
By establishing multiple qualified suppliers, implementing strict quality controls, maintaining transparent supply chain documentation, and staying abreast of regulatory updates.

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Sources
[1] International Narcotics Control Board. Annual Reports.
[2] U.S. Food and Drug Administration. Controlled Substances Security Requirements.
[3] World Health Organization. Guidelines on Good Manufacturing Practices.
[4] Indian Pharmaceuticals Industry Report, 2022.
[5] Zhejiang Huahai Pharmaceutical Annual Report, 2022.