Bulk Pharmaceutical API Sources for PHENAPHEN W/ CODEINE NO. 3

Bulk Pharmaceutical API Sources for PHENAPHEN W/ CODEINE NO. 3

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1211854
THE BioTek		bt-1549344
RR Scientific		R349760
Starshine Chemical		2023-03-15C002188

Bulk Active Pharmaceutical Ingredient (API) Sources for: PHENAPHEN W/ CODEINE NO. 3

Last updated: August 8, 2025

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Introduction

The pharmaceutical industry relies heavily on the reliable sourcing of active pharmaceutical ingredients (APIs) to manufacture maintained quality products. For combination products like PHENAPHEN W/ CODEINE NO. 3, which pairs acetaminophen (paracetamol) with codeine, securing compliant, high-quality API suppliers is critical for regulatory adherence, consistent drug efficacy, and market competitiveness. This article examines the global supply landscape for APIs used in such combination drugs, focusing on key sourcing regions, leading API manufacturers, and industry considerations.

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Overview of APIs in PHENAPHEN W/ CODEINE NO. 3

PHENAPHEN W/ CODEINE NO. 3 combines over-the-counter analgesic (acetaminophen) with a controlled opioid (codeine) at specified concentrations, typically 300 mg of acetaminophen with 30 mg of codeine per tablet. The API sourcing process involves procurement of both involved compounds—acetaminophen and codeine.

Regulatory compliance is paramount; APIs must meet stringent standards, including USP, EP, or other pharmacopeial monographs, along with Good Manufacturing Practices (GMP). Manufacturers must also ensure supply chain security due to the controlled status of codeine.

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Global API Manufacturing Hubs

1. China

Leading Role in API Production
China remains the preeminent global hub for API manufacturing, with numerous GMP-compliant plants producing both acetaminophen and codeine. Major Chinese API manufacturers such as Zhejiang Hisun Pharmaceutical Co., Ltd., and Zhejiang Huahai Pharmaceutical Co., Ltd., supply APIs to international markets, leveraging cost advantages and extensive infrastructure.

Regulatory Considerations
Despite high-volume capacity, sourcing from Chinese suppliers necessitates rigorous due diligence due to past concerns over regulatory compliance and quality consistency [[1]].

Key Chinese API Manufacturers

• Zhejiang Hisun Pharmaceutical Co., Ltd.
• Zhejiang Huahai Pharmaceutical Co., Ltd.
• Zhejiang Kanion Pharmaceutical Co., Ltd.

2. India

Growing API Sector
India offers a significant API manufacturing sector with a focus on cost-effective production and regulatory compliance. Major Indian companies like Lupin Limited, Aurobindo Pharma, and Sun Pharmaceutical Industries produce both acetaminophen and codeine APIs meeting global standards.

Regulatory Environment
Indian APIs benefit from a robust regulatory framework aligned with US FDA, EMA, and other authorities, facilitating international distribution.

Special Considerations
India's API industry is increasingly evolving toward higher quality standards, necessitating verification of GMP certifications, especially for controlled substances like codeine.

3. Europe

High-Quality API Suppliers
While Europe’s API manufacturing footprint is comparatively smaller, it emphasizes high-quality, specialized API production. Companies such as Boehringer Ingelheim and Novartis maintain APIs suitable for pharmaceutical manufacturing, though they primarily focus on finished valuable products rather than bulk APIs.

Regulatory Alignment
European APIs conform to stringent regulations, making them ideal for markets demanding high compliance.

4. United States

API Manufacturing and Bulk Supply
U.S.-based companies such as Patterson Pharmaceuticals and AmerisourceBergen supply APIs to domestic manufacturers, though imports constitute a significant portion due to high compliance standards and manufacturing costs.

Market Dynamics
The U.S. API market for controlled substances like codeine is heavily regulated via the Drug Enforcement Administration (DEA), affecting supply chain flexibility.

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Key API Suppliers for Acetaminophen and Codeine

Acetaminophen API Suppliers

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
  Widely used in global formulations; holds multiple GMP certifications.
• Sun Pharmaceutical Industries Ltd. (India)
  A major producer with ISO and cGMP compliance, serving international markets.
• Wockhardt Ltd. (India)
  Provides high-quality acetaminophen with established regulatory track records.

Codeine API Suppliers

• Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
  Large-scale production aligned with global regulatory standards.
• Hubei Huida Pharmaceutical Co., Ltd. (China)
  Specialized in controlled substance APIs, complying with international regulations.
• AbbVie (USA) and AstraZeneca (UK) (limited to finished products but with historical API production)—less common for bulk API supply.

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Regulatory and Quality Assurance in API Sourcing

API quality assurance remains critical in the production of combination drugs like PHENAPHEN W/ CODEINE NO. 3. Sourcing from GMP-compliant vendors with validated analytical methods, stability data, and traceability ensures regulatory approval across markets. Suppliers should possess comprehensive documentation, including batch records, COAs, and regulatory certifications.

Controlled substances such as codeine entail additional regulatory hurdles, including DEA registration (in the U.S.) and adherence to international conventions like the Single Convention on Narcotic Drugs (1961). Ensuring supplier compliance with these regulations is fundamental.

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Future Trends and Supply Chain Considerations

Diversification of Supply
Geopolitical tensions and regulatory changes urge manufacturers to diversify their API sources beyond traditional hubs, emphasizing supply chain resilience.

API Manufacturing Innovations
Advances in green chemistry and process optimization are modifying API production, providing opportunities for more sustainable, cost-effective sourcing.

Regulatory Vigilance
Ongoing audits and compliance monitoring are essential, especially after global scrutiny over quality standards in API manufacturing.

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Conclusion

The API sourcing landscape for PHENAPHEN W/ CODEINE NO. 3 is characterized by a global network of compliant suppliers, predominantly based in China and India. Ensuring the quality, compliance, and security of sources remains paramount, especially given the controlled status of codeine. Industry players must conduct rigorous vendor qualification, maintain regulatory vigilance, and navigate geopolitical shifts to sustain uninterrupted API supply chains.

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Key Takeaways

• Diversify API sources across regions such as China, India, and Europe to mitigate supply chain risks.
• Verify GMP compliance and regulatory certifications before engaging suppliers, particularly for controlled substances like codeine.
• Monitor regulatory developments related to narcotics and APIs to ensure ongoing compliance and avoid supply disruptions.
• Invest in quality assurance protocols and transparent documentation processes to facilitate regulatory approval processes worldwide.
• Stay abreast of innovation in API manufacturing to optimize costs and environmental sustainability efforts.

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Frequently Asked Questions

1. What are the main regions supplying APIs for PHENAPHEN W/ CODEINE NO. 3?
Primarily China and India, with secondary contributions from Europe and North America, focusing on high-quality GMP-compliant sources.

2. How does regulatory compliance impact API sourcing?
Regulatory standards such as USP, EP, and FDA guidelines determine supplier qualification. Compliance ensures product safety, efficacy, and market approval.

3. What unique challenges exist in sourcing codeine APIs?
Codeine is a controlled substance, subject to strict international and national regulations. Supply chain security, DEA licensing, and compliance with narcotics conventions are essential.

4. How can manufacturers mitigate risks associated with API supply disruptions?
By diversifying suppliers, establishing long-term supply agreements, and maintaining stockpiles, manufacturers can safeguard against disruptions.

5. What trends are expected to influence API sourcing for combination drugs?
Increased emphasis on supply chain transparency, green chemistry initiatives, and regulatory harmonization are key trends shaping future sourcing strategies.

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References

1. U.S. Food and Drug Administration (FDA). "API Manufacturing & Quality Standards." FDA.gov
2. World Health Organization (WHO). "International Narcotics Control Board Annual Reports." WHO.int
3. Markets and Markets. "API Market by Region and Type." 2022 Report.
4. Phuse. "API Supply Chain Management." 2021 Industry Report.
5. European Medicines Agency (EMA). "Guidelines on API Manufacturing." EMA.europa.eu