Bulk Pharmaceutical API Sources for ROXICET

Bulk Pharmaceutical API Sources for ROXICET

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 Roxicet

Last updated: November 11, 2025

Introduction

Roxicet, a branded pharmaceutical formulation combining oxycodone hydrochloride and acetaminophen, remains a cornerstone in managing moderate to severe pain. Its efficacy, however, hinges fundamentally on the availability of high-quality active pharmaceutical ingredients (APIs). The procurement of APIs for Roxicet, particularly oxycodone and acetaminophen, involves a complex landscape of suppliers, regulatory considerations, and quality standards. This report delineates the primary sources of bulk APIs pertinent to Roxicet production, emphasizing sourcing strategies, regulatory compliance, and supply chain integrity.

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1. Overview of APIs in Roxicet

1.1 Oxycodone Hydrochloride

Oxycodone, a semisynthetic opioid, is synthesized from thebaine, an alkaloid derived from the opium poppy. The API's potency, pharmacokinetics, and bioavailability depend largely on its synthesis route and purity levels. The global demand for oxycodone APIs has surged, driven by expanding pain management markets; however, this growth is accompanied by stringent regulatory oversight owing to the drug’s abuse potential.

1.2 Acetaminophen (Paracetamol)

Acetaminophen is a widely used analgesic and antipyretic. Its synthesis is well-established, predominantly via chemical reactions involving phenol derivatives. Given its extensive usage, acetaminophen APIs are produced by numerous suppliers, with quality standards emphasizing purity and consistency.

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2. Leading API Manufacturers for Roxicet

2.1 Oxycodone Hydrochloride API Suppliers

a) Large-Scale API Manufacturers

• Mallinckrodt Pharmaceuticals: A key player with a longstanding history in opioid manufacturing, including oxycodone APIs, primarily servicing North American markets. Their manufacturing complies with cGMP standards, and they hold multiple regulatory approvals, including from the FDA and EMEA.

• Par Pharmaceutical and Mundipharma: These companies manufacture oxycodone APIs targeting both domestic and international markets. Their compliance with Good Manufacturing Practices (GMP) ensures pharmaceutical-grade APIs suitable for formulation.

• Sun Pharmaceutical Industries: An Indian multinational supplying oxycodone APIs with an emphasis on cost-effective, high-purity products. Their facilities are GMP-certified, and they are positioned to serve global markets.

b) Chinese API Manufacturers

• Companies such as Hunan Warrant Pharmaceutical and Shandong Xinhua Pharmaceutical have increased their share of the oxycodone API market. Chinese suppliers often offer competitive pricing, though rigorous quality validation and validation audits are necessary to ensure compliance with international standards.

c) Contract Manufacturing Organizations (CMOs)

• Several CMOs in India, China, and Eastern Europe specialize in opioid API manufacturing. These organizations provide custom synthesis, scale-up capabilities, and API supply tailored to client specifications.

2.2 Acetaminophen API Suppliers

a) Established Multinational Suppliers

• BASF: Offers pharmaceutical-grade acetaminophen APIs with consistent quality, backed by extensive regulatory compliance.

• Bayer: One of the earliest producers, Bayer’s acetaminophen APIs are recognized for quality and reliability, supplied globally.

• Hikal Ltd.: An Indian API manufacturer with cGMP-certified facilities providing cost-competitive acetaminophen APIs conforming to international pharmacopoeias.

b) Other Notable Suppliers

• Viva Organics, Granules India: Focused suppliers emphasizing quality control and regulatory compliance, offering APIs suitable for both generic and branded formulations.

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3. Geographical Trends in API Sourcing

3.1 North America and Europe

These regions host APIs from established firms with stringent regulatory compliance, including FDA and EMA approvals. Their APIs are characterized by high consistency and adherence to GMP standards, though at elevated costs.

3.2 Asia-Pacific

India and China dominate the market, offering competitive pricing, flexible manufacturing capacities, and rapid scaling. Asian manufacturers often possess cGMP certifications and have made significant investments to meet global quality standards, but rigorous audits are recommended for validation.

3.3 Emerging Markets

Countries like Eastern Europe and Latin America increasingly contribute to the API supply chain. These regions can offer cost advantages but may require comprehensive regulatory evaluations to ensure compliance.

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4. Regulatory and Quality Considerations

The sourcing of APIs for Roxicet involves strict adherence to regulatory standards to ensure safety, efficacy, and legal compliance. Suppliers must demonstrate compliance with cGMP, and APIs must conform to pharmacopoeial standards (USP, EP, JP). Due diligence involves thorough audits, validation of manufacturing processes, and batch testing.

In regions with chronic regulatory restrictions on opioids, sourcing may be further complicated by export controls, licensing requirements, and overlapping international sanctions, which must be navigated carefully to maintain supply continuity.

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5. Supply Chain and Logistical Factors

Reliability in API sourcing hinges on supply chain robustness, including capacity, lead times, and geopolitical stability. Diversification of suppliers can mitigate risks, especially amid geopolitical tensions or pandemics that disrupt global production.

Qualitative assessments should include:

• Certification documentation (GMP, ISO standards)
• Past audit results
• Track record of supply continuity
• Price competitiveness

Regular validation and audit cycles ensure ongoing compliance and supply chain integrity.

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6. Strategic Sourcing Recommendations

• Comprehensive Supplier Evaluation: Prioritize suppliers with proven quality records, regulatory approvals, and scalable capacities.

• Long-term Agreements: Establish reliable supply contracts to mitigate market volatility and ensure priority access.

• Regulatory Harmonization: Engage with suppliers compliant with multiple regional standards to facilitate international distribution.

• Monitoring & Auditing: Continuous supplier performance audits and periodic quality assessments to preempt supply disruptions.

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Key Takeaways

• Procuring high-quality oxycodone hydrochloride and acetaminophen APIs is fundamental to Roxicet manufacturing, demanding rigorous due diligence and supplier validation.

• The global API sourcing landscape is dominated by North American and European firms emphasizing high regulatory standards, complemented by cost-efficient Asian manufacturers, notably in China and India.

• Due to the controlled nature of opioids like oxycodone, supply chains are heavily regulated, requiring compliance documentation and export licensing.

• Diversification of API sources and robust supply chain management strategies are critical to mitigate risks associated with geopolitical, regulatory, and logistical challenges.

• Regular audits, quality control, and adherence to international standards underpin sustainable API sourcing for Roxicet.

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FAQs

1. What are the primary regulations affecting the sourcing of oxycodone APIs?
Regulations include strict licensing requirements under Controlled Substances Acts, international export controls, and compliance with cGMP standards mandated by agencies like the FDA and EMA. Manufacturers must also be registered and licensed to produce controlled substances.

2. How can companies verify the quality of Asian API suppliers?
Verification involves auditing manufacturing facilities, reviewing GMP certifications, analyzing batch quality reports, and conducting third-party laboratory testing to confirm API purity and compliance.

3. Are there alternative sources for oxycodone APIs outside China and India?
Yes. Europe and North America host several reputable manufacturers. However, these sources often come at higher costs and may have longer lead times. Emerging markets in Eastern Europe and Latin America are also developing capabilities.

4. What are the risks associated with importing APIs for Roxicet?
Key risks include regulatory non-compliance, supply disruptions, quality inconsistencies, and geopolitical issues such as sanctions or export bans. Thorough vetting and compliance measures mitigate these risks.

5. How does supply chain diversification impact API procurement?
Diversification reduces dependency on a single supplier or region, alleviating risks related to geopolitical instability, natural disasters, or pandemics. Strategic diversification enhances supply resilience and operational continuity.

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References

1. U.S. Food and Drug Administration (FDA). Guidance for Industry: Submission of Drug Establishment Registration and Drug Listing Information.
2. European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice.
3. IMS Health. Global Opioid Market Analysis.
4. PwC. Global API Market Trends and Regulatory Landscape.
5. International Narcotics Control Board (INCB). Report on Opioid Production and Consumption.