Bulk Pharmaceutical API Sources for PHENAPHEN W/ CODEINE NO. 2

Bulk Pharmaceutical API Sources for PHENAPHEN W/ CODEINE NO. 2

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. 2

Last updated: August 5, 2025

Introduction

The demand for pharmaceutical ingredients like Phenaphen with Codeine No. 2 reflects its vital role in analgesic and antitussive formulations. As a combination of acetaminophen (paracetamol) and codeine, this product addresses moderate to severe pain and cough suppression. Ensuring quality, reliable, and compliant API sourcing is crucial for pharmaceutical manufacturers, especially amid tightening regulatory standards and supply chain complexities.

This comprehensive analysis examines the global landscape of API suppliers for Phenaphen with Codeine No. 2, encompassing key geographic regions, regulatory considerations, and supply chain insights relevant to industry stakeholders aiming to optimize sourcing strategies.

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Understanding the API Composition: Phenaphen and Codeine

Phenaphen typically refers to a formulation incorporating acetaminophen, a widely used analgesic and antipyretic ingredient. Codeine, an opioid analgesic, provides potent pain relief and cough suppression. The active pharmaceutical ingredients (APIs) include:

• Acetaminophen (Paracetamol): A globally approved non-opioid analgesic with a well-established supply chain.

• Codeine phosphate: An opioid with controlled status, subject to stringent manufacturing and distribution regulations.

The formulation Phenaphen with Codeine No. 2 generally contains specific concentrations of each API, often in a patent or regulatory framework governed by local authorities.

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Global API Manufacturers and Suppliers for Acetaminophen

1. India

India stands as a dominant producer of acetaminophen, with multiple manufacturers adhering to international regulatory standards like USFDA, EMA, and WHO-GMP.

• Sun Pharmaceutical Industries Ltd.
  A leading Indian pharmaceutical company producing high-quality acetaminophen for domestic and export markets. Its supply chain is robust, with manufacturing plants compliant with global standards.

• Lupin Limited
  Known for its extensive API portfolio, including acetaminophen, with global distribution channels and strict quality control measures.

• Aurobindo Pharma
  Manufactures acetaminophen API, offering competitive pricing and reliable supply for pharmaceutical producers worldwide.

2. China

Chinese API manufacturers are significant contributors to the global supply of acetaminophen.

• Hunan Huasheng Pharmaceuticals Co., Ltd.
  Provides a broad portfolio of pharmaceutical APIs, including acetaminophen, with certifications for export to regulated markets.

• Zhejiang Huaihai Pharmaceutical Co., Ltd.
  Supplies acetaminophen API with compliance to international standards, serving both generic and branded markets.

3. Europe

European API producers focus on high purity and strict regulatory compliance.

• BASF SE (Germany)
  Offers pharmaceutical-grade acetaminophen with high purity, adhering to stringent EU standards.

• Vaccine and Pharmaceutical Ingredients (VPI), UK
  Produces acetaminophen APIs with GMP certification, catering primarily to European markets.

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API Suppliers for Codeine

Codeine as an opioid is subject to strict regulatory controls globally, affecting sourcing options.

1. India

Indian pharmaceutical companies are primary global suppliers of pharmaceutical-grade codeine, leveraging their mature production infrastructure.

• Sun Pharmaceutical Industries Ltd.
  Produces codeine phosphate with GMP compliance, supplying to both domestic and international markets after appropriate licensing.

• Zee Laboratories Ltd.
  Focused on API manufacturing for opioids, including codeine, with adherence to international regulatory standards.

• Gujarat Bottling Co. Ltd.
  Engaged in the manufacturing and export of codeine API, adhering to controlled substance regulations.

2. China

Chinese API manufacturers produce codeine under strict licensing and regulatory oversight.

• Hunan Weco Pharmaceutical Co., Ltd.
  A recognized supplier of pharmaceutical-grade opioids, including codeine, with quality certifications.

• Jiangsu Lianyun Chemical Co., Ltd.
  Supplies codeine phosphate API to regulated markets, emphasizing compliance with Good Manufacturing Practices.

3. Other Regions

• South Africa: Pharmaceutical companies such as Aspen Pharmacare supply codeine APIs, primarily for regional markets.

• Europe: Due to tight regulations, European suppliers focus on final formulations or source from compliant international producers.

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Regulatory and Quality Considerations

Given the controlled status of codeine, suppliers must comply with international and national controls, including:

• International Narcotics Control Board (INCB) regulations
• United States Drug Enforcement Administration (DEA) licensing for suppliers and distributors (for U.S. market)
• European Medicines Agency (EMA) standards globally

For acetaminophen, regulatory burdens are comparatively less stringent but still mandate GMP compliance, purity, and consistent quality metrics.

Pharmaceutical companies must verify supplier credentials, registration numbers, and quality certifications (e.g., USFDA, EMA, WHO-GMP) before engagement.

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Supply Chain Challenges and Trends

1. Regulatory Compliance

Stringent controls over opioids like codeine create barriers to entry and supply chain opacity. Manufacturers must ensure suppliers have valid licenses and adherences.

2. Supply Security and Diversification

Dependence on single-region suppliers exposes companies to geopolitical, environmental, and regulatory risks. Diversification across India, China, and regulated markets like Europe mitigates disruptions.

3. Price Dynamics

Fluctuations in raw material prices, regulatory costs, and global demand influence API pricing. Indian and Chinese suppliers typically offer competitive pricing but face compliance scrutiny for quality assurance.

4. Impact of Policy Changes

Evolving restrictions on opioid production and distribution may impact API availability. For example, recent global tightening of codeine regulations affects supply timelines and supplier operations.

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Conclusion

Securing a reliable, compliant API supply for Phenaphen with Codeine No. 2 hinges on identifying reputable suppliers within regulated regions and maintaining robust quality oversight. Indian and Chinese manufacturers dominate as primary sources for both acetaminophen and codeine, with European suppliers emphasizing high purity and compliance.

Manufacturers should prioritize establishing strategic relationships with multiple certified suppliers to ensure continuity, regulatory adherence, and cost efficiency.

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Key Takeaways

• India and China are the primary global sources for API components—acetaminophen and codeine—due to established manufacturing capabilities and cost advantages.
• Regulatory compliance is critical, especially for codeine, which involves strict licensing and control measures globally. Always verify supplier certifications like USFDA, EMA, and WHO-GMP.
• Supply chain diversification reduces risks posed by geopolitical, environmental, or legislative changes impacting API availability.
• Market trends indicate increasing regulatory scrutiny over opioids, potentially affecting supply stability and pricing dynamics.
• Due diligence in supplier vetting and continuous quality assurance are essential to maintain regulatory compliance and product integrity.

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FAQs

1. How do I verify the authenticity of an API supplier for Phenaphen with Codeine No. 2?
Ensure suppliers possess recognized certifications such as USFDA, EMA, or WHO-GMP, and verify their licensing for controlled substances from relevant authorities. Conduct on-site audits and review batch quality reports to confirm compliance.

2. Are Chinese API suppliers reliable for phenacetin and codeine components?
Many Chinese manufacturers deliver high-quality APIs adhering to international standards, but thorough due diligence, including certification verification and regulatory audits, is essential to mitigate risk.

3. What are the regulatory considerations for sourcing codeine API?
Codeine is classified as a controlled substance in most jurisdictions. Suppliers must hold valid licenses, and procurement must comply with local narcotics laws, import/export controls, and international agreements.

4. How does geopolitical risk impact API sourcing for Phenaphen with Codeine No. 2?
Geopolitical tensions may affect trade policies, tariffs, and export permissions, especially related to opioids. Diversifying supplier bases across regions reduces dependency and supply vulnerability.

5. What future trends should manufacturers consider for API sourcing?
Market trends suggest increasing regulatory oversight on opioid APIs, requiring enhanced compliance measures. Automation of quality assurance and shifts toward sustainable manufacturing practices will also shape sourcing strategies.

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References

[1] International Narcotics Control Board (INCB). Regulations on Opioid APIs. 2022.
[2] U.S. Food and Drug Administration (FDA). API Manufacturer Databases. 2023.
[3] European Medicines Agency (EMA). GMP Guidance for Active Pharmaceutical Ingredients. 2023.
[4] Indian Pharmaceutical Alliance. API Industry Overview. 2022.
[5] Chinese Pharmaceutical Industry Report. Market Dynamics and Regulatory Environment. 2022.