Bulk Pharmaceutical API Sources for PHENAPHEN-650 W/ CODEINE

Bulk Pharmaceutical API Sources for PHENAPHEN-650 W/ CODEINE

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-650 W/ CODEINE

Last updated: August 4, 2025

Introduction

The pharmaceutical landscape requires reliable, compliant, and high-quality sources of active pharmaceutical ingredients (APIs), especially for combination medications like PHENAPHEN-650 with codeine. This medication combines acetaminophen (paracetamol) with codeine phosphate and is often prescribed for moderate to severe pain management. Ensuring consistent sourcing of APIs is critical for regulatory compliance, manufacturing quality assurance, and supply chain stability. This article offers a comprehensive overview of top API suppliers for acetaminophen and codeine, emphasizing market trends, regulatory considerations, and key factors influencing procurement decisions.

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Overview of PHENAPHEN-650 W/ CODEINE Composition

PHENAPHEN-650 W/ CODEINE is a combination analgesic containing:

• Acetaminophen (650 mg per tablet): A widely used analgesic and antipyretic.
• Codeine phosphate (30 mg per tablet): An opioid analgesic, classified as a controlled substance.

The manufacturing of this product hinges on the reliable sourcing of both APIs, each with distinct regulatory pathways, quality specifications, and sourcing challenges.

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Key Considerations in API Sourcing

Regulatory Compliance:
APIs must comply with Good Manufacturing Practices (GMP) standards outlined by agencies such as the FDA, EMA, and others. Suppliers often hold certifications like ISO, WHO-GMP, or EDQM certifications.

Quality Assurance:
Sourcing from reputable APIs manufacturers ensures purity, stability, and bioavailability, crucial for patient safety and efficacy.

Supply Chain Stability:
Long-term reliability, capacity for scale-up, and geopolitical stability influence supplier selection.

Pricing and Lead-Time:
Cost competitiveness, delivery timelines, and flexibility are vital, especially in responding to market demand fluctuations.

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Primary API Sources for Acetaminophen

Market Overview

Acetaminophen, known as paracetamol outside North America, is among the world's most widely produced APIs. Major suppliers span China, India, Europe, and North America, with China and India dominating global production due to cost advantages and manufacturing capacity.

Leading Suppliers of Acetaminophen

1. Hubei Xiongda Pharmaceutical Co., Ltd. (China):
   A leading manufacturer with GMP certification, offering high-purity acetaminophen with global distribution channels.

2. Minghuan Pharmaceutical Ltd. (India):
   A reputable supplier with WHO-GMP certification, providing batch stability and scalable production.

3. Yunnan Shuangjing Pharmaceutical Co., Ltd. (China):
   Specializes in large-volume APIs meeting international quality standards.

4. Hoffmann-La Roche (Switzerland):
   Known for high-quality APIs, though often limited to bulk for branded formulations.

5. Hicks Chemical Co., Ltd. (China):
   Provides pharmaceutical-grade acetaminophen with rigorous quality controls.

Regulatory and Quality Considerations

Suppliers should hold certifications such as FDA facility registration, EDQM certifications, or equivalent, depending on the market. Batch consistency, impurity profiles, and compliance with pharmacopeial standards (USP, BP, EP) are critical parameters.

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Primary API Sources for Codeine

Market Overview

Codeine is an opiate, classed as a controlled substance. Sourcing must comply with strict international and local regulations, including import/export controls, licensing, and traceability standards.

Leading Suppliers of Codeine

1. Sun Pharmaceutical Industries Ltd. (India):
   A global API manufacturer with robust WHO-GMP certification, known for high-quality codeine phosphate.

2. Zhejiang Hisoar Pharmaceutical Co., Ltd. (China):
   Specializes in codeine APIs compliant with international standards, with extensive export experience.

3. Hoffmann-La Roche (Switzerland):
   Provides premium APIs including codeine, with extensive quality controls and regulatory compliance.

4. Sichuan Hisoar Pharmaceutical Co., Ltd. (China):
   Offers codeine phosphate with a focus on strict purity standards and GMP compliance.

5. Xiangsheng Pharmaceutical Co., Ltd. (China):
   Known for reliable supply chains, with rigorous quality assurance measures.

Regulatory and Legal Constraints

Codeine API sourcing is heavily regulated; suppliers must comply with the Convention on Psychotropic Substances (1961) and national drug control laws. Import licensing and end-use documentation are mandatory for international procurement.

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Emerging Trends and Challenges in API Sourcing

Global Supply Chain Disruptions

The COVID-19 pandemic highlighted vulnerabilities in supply chains, prompting manufacturers to diversify sourcing strategies. Dependency on Chinese and Indian suppliers remains high but poses risks related to geopolitical considerations, tariffs, and export restrictions.

Stringent Regulatory Environment

As regulators tighten manufacturing requirements (e.g., US FDA's outsourcing facility inspections, EMA updates), suppliers must maintain high compliance standards, which may influence lead times and costs.

API Certification and Traceability

Increasing demand for transparent supply chains has led to an emphasis on serialization, batch traceability, and third-party audits. These measures mitigate counterfeiting and ensure API integrity.

Shift Toward Localized API Production

Some regions are incentivizing local manufacturing to reduce reliance on imported APIs, driven by national security concerns and supply chain resilience.

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Selecting API Suppliers for PHENAPHEN-650 W/ CODEINE

When sourcing APIs for this combination medication, consider the following:

• Certifications and Compliance: Ensure suppliers meet GMP, ISO, and pharmacopeial standards.
• Quality Data and Certifications: Review analytical reports, impurity profiles, and stability data.
• Supply Chain Reliability: Evaluate production capacity, geographic diversification, and historical delivery consistency.
• Pricing Structures: Negotiate for competitive pricing within quality parameters.
• Regulatory Support: Prefer suppliers familiar with international regulatory submissions and documentation requirements.

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Conclusion

Reliable sourcing of acetaminophen and codeine APIs remains a cornerstone of producing PHENAPHEN-650 W/ CODEINE. Chinese and Indian manufacturers dominate the market owing to their capacity and cost advantages, but regulatory rigor necessitates comprehensive due diligence. Global manufacturers and distributors focusing on quality, compliance, and supply stability can mitigate risks associated with geopolitical uncertainties and supply chain disruptions. Building strategic supplier relationships aligned with regulatory standards ensures consistent drug formulation quality and market competitiveness.

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Key Takeaways

• Major bulk API suppliers for acetaminophen are predominantly based in China and India, with global players in Europe and North America as high-end providers.
• Codeine API sourcing is constrained by strict regulatory controls; suppliers with strong regulatory compliance and licensing are essential.
• Diversification of API sources mitigates risk amid geopolitical tensions, trade restrictions, and supply chain disruptions.
• Certifications such as WHO-GMP, ISO, and pharmacopeial compliance are non-negotiable in supplier evaluation.
• Strategic partnerships with reputable API manufacturers support consistent quality, regulatory readiness, and supply chain resilience for PHENAPHEN-650 W/ CODEINE production.

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FAQs

1. What are the main regulatory considerations when sourcing APIs for PHENAPHEN-650 with codeine?
Sourcing must comply with domestic and international regulations, including GMP standards, import/export licensing, and controlled substance regulations for codeine, such as the UN Single Convention on Narcotic Drugs.

2. How can supply chain risks for APIs be mitigated?
Diversifying suppliers across regions, verifying certifications, establishing long-term agreements, and maintaining inventory buffers help mitigate disruptions.

3. Are there readily available alternatives to Chinese and Indian API suppliers?
European and North American suppliers offer high-quality APIs but often at higher costs and with longer lead times; leveraging multiple suppliers across regions enhances supply security.

4. How does regulatory status affect the choice of API suppliers?
Suppliers with recognized certifications (e.g., EDQM, FDA-approved facilities) simplify regulatory submissions and compliance, reducing hurdles in international markets.

5. What trends are influencing API sourcing strategies?
Increasing regulatory scrutiny, geopolitical considerations, supply chain resilience initiatives, and technological advancements are prompting a shift toward diversified and vertically integrated sourcing models.

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References
[1] Pharmacopoeia standards and API regulatory guidelines.
[2] Market reports on pharmaceutical API manufacturing.
[3] International drug control conventions and regulations.
[4] Industry white papers on supply chain resilience.