Bulk Pharmaceutical API Sources for TYLENOL W/ CODEINE NO. 1

Bulk Pharmaceutical API Sources for TYLENOL W/ CODEINE NO. 1

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 Tylenol with Codeine No. 1

Last updated: August 17, 2025

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Introduction

Tylenol with Codeine No. 1 is a prescription analgesic combining acetaminophen (paracetamol) with a low dose of codeine phosphate. It is commonly prescribed for moderate pain relief, especially when non-opioid options prove insufficient. The pharmaceutical efficacy and safety profile of this combination hinge on the quality and consistency of its active pharmaceutical ingredients (APIs)—acetaminophen and codeine phosphate. Sourcing high-quality APIs is critical for manufacturers to meet stringent regulatory standards, ensure product safety, and maintain market trust. This analysis explores the global landscape of API suppliers for Tylenol with Codeine No. 1, focusing on the sources for both acetaminophen and codeine phosphate.

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Regulatory Context and Industry Standards

API sourcing for combination products like Tylenol with Codeine No. 1 involves compliance with Good Manufacturing Practices (GMP), validated quality control processes, and adherence to guidelines from authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO). Suppliers must provide comprehensive Certificates of Analysis (CoA), demonstrating potency, purity, and absence of residual solvents or contaminants. Regional regulations influence sourcing preferences; for example, North American manufacturers often prioritize U.S.-based or approved suppliers, while European and Asian markets may adopt different standards.

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Sources of Acetaminophen API

Major Global Suppliers

1. Hubei Great Wall Pharmaceutical Chemical Co., Ltd. (China)
   A prominent manufacturer supplying pharmaceutical-grade acetaminophen globally. The company emphasizes ISO 9001 and GMP certifications. Their acetaminophen features high purity (>99%), low residual solvents, and consistent batch-to-batch quality, making it a preferred source for OTC and prescription medicines.

2. Mitsubishi Chemical Corporation (Japan)
   Known for high-quality pharmaceutical intermediates, Mitsubishi supplies acetaminophen meeting the strict safety and efficacy standards required by Japanese and Western markets. Their API complies with pharmacopoeial standards (USP, EP), ensuring reliability.

3. Hawkins, Inc. (United States)
   As a leading supplier of chemical ingredients, Hawkins offers acetaminophen API manufactured under GMP with a focus on North American pharmaceutical manufacturers. They maintain rigorous quality controls, including detailed CoA documentation.

4. Kansu Pharmaceutical Co., Ltd. (China)
   An ISO-certified producer providing acetaminophen API, with a history of supplying to large pharmaceutical firms across North America and Europe. Their product meets pharmacopeial standards and is approved for licensed medicines.

5. Shandong Xinhua Pharmaceutical Co., Ltd. (China)
   Recognized for affordable, high-purity acetaminophen API, with certifications supporting GMP compliance. Their API is used extensively in generic and branded OTC formulations.

Key Considerations

• Purity and Batch Consistency: Suppliers should demonstrate stringent QA/QC processes, with minimal impurities.
• Regulatory Approvals: Suppliers with current certifications aligned to target markets streamline registration.
• Capacity and Lead Time: Large-scale providers ensure consistent supply, crucial for manufacturing continuity.

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Sources of Codeine Phosphate API

Major Global Suppliers

1. Shandong Xinhua Pharmaceutical Co., Ltd. (China)
   They are one of the largest producers of codeine phosphate globally, complying with GMP and WHO certifications. Their API is widely used in cough syrups and opioid analgesics, including Tylenol with Codeine formulations.

2. Mallinckrodt Pharmaceuticals (United States/Global)
   A globally recognized producer of pharmaceutical opioids, including codeine phosphate. Mallinckrodt supplies APIs to licensed manufacturers with extensive regulatory documentation, ensuring supply security and high quality.

3. Sun Pharmaceutical Industries Ltd. (India)
   One of India’s leading API manufacturers, Sun Pharma offers codeine phosphate compliant with international pharmacopoeia standards (USP, BP). Their facilities maintain GMP standards and are approved by various regulators.

4. LGM Pharma (United States)
   Specializes in bulk APIs including opioids like codeine phosphate, with a focus on quality, purity, and compliance with international standards. They serve contract manufacturers worldwide.

5. Granules India Ltd. (India)
   An ISO-certified producer of opioids, including codeine phosphate, with a strong export footprint. Their API complies with all relevant pharmacopoeial standards and quality systems.

Key Considerations

• Legal and Regulatory Frameworks: Due to the high potential for abuse, sourcing from suppliers compliant with controlled substance regulations (e.g., DEA, EMA, NDLEA) is essential.
• Quality Assurance: Suppliers should offer comprehensive documentation, including stability data and process validation.
• Traceability: Ensuring batch traceability aligns with Good Distribution Practices (GDP) and legal requirements.

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Regional Sourcing Trends and Challenges

North America

Manufacturers generally prefer APIs from approved domestic or international suppliers with established track records, emphasizing regulatory compliance and ongoing supply stability. The USA’s Drug Enforcement Administration (DEA) tightly regulates codeine, influencing sourcing and inventory management.

Europe

Sourcing aligns with European Pharmacopoeia standards. Suppliers such as Sun Pharma and Granules India are increasingly important, supported by EU-certified manufacturing facilities.

Asia

China and India dominate global API supply chains due to cost advantages, large manufacturing capacities, and compliance with international standards. Chinese API producers often hold certifications like ISO 9001, ISO 14001, and GMP, facilitating export to regulated markets.

Challenges

• Regulatory Variability: Differing regional controls on opioids complicate sourcing and shipment.
• Quality Assurance: Variability in API quality can impact product efficacy and regulatory approval.
• Supply Chain Disruptions: Geopolitical issues, trade restrictions, and pandemic-related disruptions impact API availability.

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Emerging Trends and Industry Developments

• API Manufacturing Consolidation: Consolidation among key players fosters supply stability but may increase dependence on few sources.
• Enhanced Quality Controls: Increased regulatory scrutiny drives API suppliers to adopt advanced quality assurance measures.
• Sustainable and Ethically Sourced APIs: Growing emphasis on environmental impact and responsible sourcing influences procurement decisions.

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Conclusion

The sourcing of APIs for Tylenol with Codeine No. 1 involves a global network of qualified manufacturers, predominantly based in China, India, and the United States. For acetaminophen, suppliers like Hubei Great Wall Pharmaceutical and Mitsubishi Chemical are prominent, while codeine phosphate sourcing centers around companies such as Shandong Xinhua Pharmaceutical and Mallinckrodt. Ensuring API quality, regulatory compliance, and supply stability remains paramount for manufacturers aiming to deliver safe, effective, and compliant opioids combined with non-opioid analgesics.

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Key Takeaways

• High-Quality API Suppliers: Prioritize suppliers with rigorous GMP standards, certified by recognized regulatory agencies.
• For Acetaminophen: Focus on Chinese and Japanese producers with proven purity and batch consistency.
• For Codeine Phosphate: Rely on suppliers compliant with controlled substance regulations and possessing controlled substance manufacturing licenses.
• Regulatory Compliance: Select suppliers with documented certifications aligning with target market requirements.
• Supply Chain Resilience: Diversify sourcing to mitigate geopolitical and logistical risks, ensuring continuous manufacturing.

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FAQs

Q1: Are Chinese API suppliers for acetaminophen and codeine phosphate reliable?
A1: Yes. Many Chinese suppliers, such as Hubei Great Wall Pharmaceutical and Shandong Xinhua Pharmaceutical, operate under stringent GMP standards and possess necessary certifications, making them reliable sources for high-quality APIs globally.

Q2: What regulatory hurdles exist in sourcing codeine phosphate?
A2: As a controlled substance, codeine phosphate sourcing involves compliance with strict regulations such as DEA in the US or EMA approvals in Europe. Suppliers must provide detailed legal documentation, and shipments are subject to import/export restrictions.

Q3: How do manufacturing quality standards impact API selection?
A3: High manufacturing standards—GMP compliance, certification by recognized authorities, reliable QA/QC processes—are essential to ensure API purity, potency, and safety, directly affecting the quality of the final product.

Q4: Is regional sourcing preferable for Tylenol formulations?
A4: Manufacturers tend to prefer APIs from regions with stringent regulatory oversight—such as North America, Europe, and Japan—to streamline regulatory approval and compliance. However, quality standards in emerging markets are increasingly aligning with international benchmarks.

Q5: How can I verify the authenticity and quality of an API supplier?
A5: Verify certifications (GMP, ISO), request detailed Certificates of Analysis, review third-party audits, confirm regulatory approvals, and source APIs from suppliers with established track records in regulated markets.

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Sources:

1. [1] U.S. Food and Drug Administration (FDA) Drug Approved List
2. [2] European Medicines Agency (EMA) Approved APIs Database
3. [3] WHO ≥ International Pharmacopoeias
4. [4] Industry reports on API manufacturing standards, IQVIA, and global supply chain analyses
5. [5] Company disclosures and certification documents from major API producers