Bulk Pharmaceutical API Sources for PHENAPHEN W/ CODEINE NO. 4

Bulk Pharmaceutical API Sources for PHENAPHEN W/ CODEINE NO. 4

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. 4

Last updated: July 29, 2025

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Introduction

Phenaphen W/ Codeine No. 4 is a prescription opioid analgesic combining acetaminophen (paracetamol) with codeine. This formulation is used for moderate to severe pain management, often in clinical settings. Due to its controlled status, sourcing its active pharmaceutical ingredients—acetaminophen and codeine—requires strict adherence to legal, regulatory, and quality standards. This article examines the primary sources for bulk APIs of phenaphen with codeine No. 4, highlighting global manufacturers, procurement considerations, and regulatory challenges pertinent to business professionals.

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Regulatory Framework and Market Overview

The manufacturing and distribution of APIs for controlled substances like codeine are regulated by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and respective national authorities. The Drug Enforcement Agency (DEA) in the United States classifies codeine as a Schedule II or Schedule III substance depending on the formulation, imposing restrictions on manufacturing, bulk import, and export.

The global market for APIs encompasses manufacturers across North America, Europe, India, China, and other regions. Among these, India and China dominate as primary suppliers due to their extensive pharmaceutical manufacturing infrastructure, capacity, and cost advantages.

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Major API Manufacturers for Acetaminophen

Acetaminophen (paracetamol) is a widely used over-the-counter analgesic and antipyretic. Its API production is widespread, with several reputable suppliers:

• Hanwang Pharmaceutical Co., Ltd. (China): One of the leading producers, offering high-quality acetaminophen APIs compliant with international standards.

• Huzhou Zhongbo Pharmaceutical Co., Ltd. (China): Offers pharmaceutical-grade acetaminophen, serving API and finished drug markets globally.

• Lifficult Chemicals (India): Supplies certified acetaminophen APIs suited for analgesic formulations, adhering to cGMP standards.

• Zhejiang Kangle Pharmaceutical Co., Ltd. (China): A significant player in the acetaminophen API market with consistent quality.

• Sun Pharmaceutical Industries Ltd. (India): Offers acetaminophen bulk API, with a focus on quality compliance and reliable supply.

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Major API Manufacturers for Codeine

Codeine is a controlled opioid derived from the opium poppy. Its API manufacturing involves complex extraction and synthesis processes. The key regional suppliers include:

• SUN Pharmaceutical Industries Ltd. (India): A leading global API producer of codeine, meeting stringent regulatory standards.

• Glenmark Pharmaceuticals (India): Supplies high-quality codeine APIs, complying with international cGMP standards.

• Shandong Xinhua Pharmaceutical Co., Ltd. (China): Engaged in the synthesis and bulk supply of codeine APIs, with multiple certifications.

• Hubei Yitai Pharmaceutical Co., Ltd. (China): Offers codeine phosphate APIs suitable for pharmaceutical manufacturing.

• Sanofi (France): Historically a major supplier, though their focus has shifted toward finished formulations; smaller scale API manufacturing may be available via partnerships.

Manufacturers supplying codeine APIs typically operate under strict licensing due to regulatory controls stemming from its narcotic classification.

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Sourcing Considerations

Regulatory Compliance

Sourcing APIs for phenaphen with codeine No. 4 requires careful validation of manufacturing practices, cGMP compliance, and certification documents such as Certificate of Suitability (CEP) or Drug Master Files (DMF). Regulatory acceptance varies across markets; hence, sourcing from approved and certified suppliers is essential.

Quality Assurance

High purity standards (generally 99% or higher), batch-to-batch consistency, and comprehensive testing reports are mandatory. Suppliers should provide extensive analytical data, stability test results, and regulatory certifications.

Supply Chain and Logistics

Due to the controlled nature of codeine, sourcing often involves governmental approvals for import/export, secure transportation, and storage facilities compliant with narcotics regulations.

Pricing and Capacity

Market dynamics, geopolitical stability, and manufacturing capacity influence pricing. Indian manufacturers tend to offer cost-effective APIs with broad export experience, while Chinese suppliers may provide competitive pricing with rapid lead times.

Legal and Ethical Considerations

Due to the narcotic classification, buyers must ensure full compliance with local and international drug control laws. Establishing relationships with reputable, licensed suppliers mitigates risks of legal infringements.

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Key Global API Suppliers and Market Dynamics

Supplier	Region	Specialization	Certifications	Remarks
Hanwang Pharmaceutical	China	Acetaminophen	GMP, ISO	High-volume, quality-focused
GVK Biosciences	India	API manufacturing	cGMP	Established supply chain
Zhejiang Kangle Pharma	China	Acetaminophen	CE, GMP	Cost-effective bulk APIs
Sun Pharma	India	Both APIs	WHO-GMP, ISO	Trusted global supplier
Shandong Xinhua	China	Codeine	cGMP, ISO	Narcotic license compliant

Note: Availability may fluctuate based on regional regulations and geopolitical factors.

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Regulatory Challenges and Due Diligence

Sourcing APIs for narcotics like codeine involves navigating complex legal contexts. Many countries restrict API exports via stringent licensing. Suppliers must hold valid narcotic manufacturing licenses, and buyers are advised to verify compliance with relevant authorities such as the DEA (USA), EMA (EU), or national narcotics agencies. Additionally, geopolitical tensions can influence supply continuity, emphasizing the importance of diversified sourcing strategies and establishing robust due diligence protocols.

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Future Trends and Industry Outlook

The API supply landscape for phenaphen with codeine No. 4 is poised for evolution driven by regulatory tightening, opioid stewardship initiatives, and shifts toward abuse-deterrent formulations. Growth in the generic pharmaceutical sector in Asia continues to expand capacity, offering strategic opportunities for business professionals. However, increased regulatory scrutiny may impact supply availability and costs.

Emerging regulations may favor APIs with proven quality compliance, ingredient traceability, and sustainability credentials. Manufacturers investing in quality management systems and transparent supply chains will be better positioned in the evolving market.

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Conclusion

Sourcing bulk APIs for phenaphen with codeine No. 4 requires navigating a complex matrix of regulatory, quality, and logistical considerations. Reputable manufacturers primarily originate from India and China, with stringent licensing and compliance standards serving as gatekeepers. Business professionals must conduct thorough due diligence, prioritize certified suppliers, and remain vigilant about regulatory developments to secure reliable supply chains.

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Key Takeaways

• Most bulk phenaphen APIs, acetaminophen, and codeine originate from India and China, with high manufacturing volumes and competitive pricing.
• Regulatory compliance, particularly concerning narcotic licenses and quality certifications, is essential for legal and safe procurement.
• Due diligence on suppliers’ certifications, manufacturing standards, and legal licenses mitigates compliance and supply chain risks.
• Increasing regulatory scrutiny necessitates transparent sourcing practices and diversification to prevent supply disruptions.
• Future industry developments include stricter regulations, growth in API manufacturing capacities, and the adoption of abuse-deterrent formulations.

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Frequently Asked Questions

1. What are the primary regulatory considerations when sourcing codeine APIs globally?
Suppliers must possess valid narcotic licenses approved by local regulatory agencies, adhere to cGMP standards, and provide comprehensive documentation, including certificates of analysis. Buyers must ensure import/export compliance with narcotics regulations in their jurisdictions.

2. How does regional manufacturing impact API quality and supply stability?
India and China dominate API manufacturing, offering scalability and cost advantages. However, regional regulatory differences, quality assurance standards, and political factors can influence supply continuity and quality consistency.

3. What are the risks associated with counterfeit or substandard APIs?
Counterfeit APIs can compromise drug safety, lead to regulatory penalties, and harm brand reputation. Rigorous supplier validation, audits, and verification of analytical data are essential to mitigate these risks.

4. How does the controlled status of codeine influence sourcing strategies?
Controlled status demands strict licensing, documentation, and security measures. Procurement requires close coordination with authorities and licensed distributors, often resulting in longer lead times and higher compliance costs.

5. Are there any alternative APIs or formulations to phenaphen with codeine No. 4 that are less regulated?
Alternatives include non-opioid analgesics like NSAIDs or acetaminophen alone. However, they may not provide equivalent efficacy for moderate to severe pain. Non-controlled opioids may also be considered, but their use entails similar regulatory scrutiny.

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References

1. U.S. Food and Drug Administration (FDA). Guidance for Industry: Control of Narcotic API Supply. [FDA Website]
2. European Medicines Agency (EMA). Guidelines on the manufacture of controlled substance APIs.
3. World Health Organization (WHO). Model List of Essential Medicines.
4. Indian Drug Controller General of India. API licensing and compliance guidelines.
5. Chinese National Medical Products Administration (NMPA). API manufacturing regulations.