PROMETHAZINE WITH CODEINE bulk active fine chemical sources

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Last updated: August 7, 2025

Introduction

Promethazine with codeine is a combination medication renowned for its efficacy in treating cough, cold, and allergy symptoms, particularly where sedation or suppression of cough reflexes is necessary. The formulation typically pairs promethazine, an antihistamine with sedative properties, with codeine, an opioid analgesic and antitussive agent. Due to the controlled status of codeine, sourcing bulk Active Pharmaceutical Ingredients (APIs) for manufacturing this combination involves navigating strict regulatory channels and a limited supplier landscape.

This analysis explores the landscape of bulk API suppliers for promethazine and codeine, highlighting manufacturing regions, key industry players, sourcing considerations, regulatory frameworks, and the implications for pharmaceutical companies.

Global API Manufacturing Landscape for Promethazine and Codeine

Promethazine API

Manufacturing Regions:
Promethazine API production is concentrated predominantly in Asia, notably in China and India. These countries possess extensive chemical manufacturing infrastructure, enabling cost-effective production of APIs with high volume capacities.

Major Suppliers:
Leading API manufacturers of promethazine in these regions include:

Zhejiang Hisun Pharmaceutical Co., Ltd. (China):
Known for comprehensive API portfolios, including phenothiazines used in antihistamines.
Hubei Wuchang Shipbuilding Industry Group Co., Ltd. (China):
Supplies various phenothiazines, including promethazine.
Avon Chemicals Pvt Ltd. (India):
Offers generic promethazine API, complying with cGMP standards.

Quality and Regulatory Considerations:
Manufacturers in these regions often produce API batches adhering to USP, EP, or other pharmacopeial standards, with some possessing certifications such as cGMP and ISO. However, due diligence concerning manufacturing audits and regulatory compliance is vital when sourcing from Asian suppliers, especially with respect to impurity profiles and batch reproducibility.

Codeine API

Manufacturing Regions:
Codeine, an opioid API, is produced in jurisdictions with established controlled substance manufacturing, notably China, India, and some European countries.

Major Suppliers:

Sun Pharmaceutical Industries Ltd. (India):
One of the largest producers of pharmaceutical APIs, including controlled substances like codeine, operating under strict regulatory oversight.
Mammut Pharma Chem (India):
Specializes in opioids and controlled APIs, adhering to international standards.
Zhejiang Hisun Pharmaceutical Co., Ltd. (China):
Provides codeine APIs under strict compliance with regulatory authority licensing (e.g., NMPA, USDEA).
Glenmark Pharmaceuticals Ltd. (India):
Engages in manufacturing opioids for pharmaceutical use, with rigorous compliance ensuring quality standards.

Regulatory and Compliance Considerations:
Codeine APIs are categorized as Schedule II or III controlled substances in many jurisdictions. Manufacturers must possess appropriate Drug Enforcement Agency (DEA) registration (US), or equivalent licenses (e.g., NDPS Act in India, NMPA in China). Suppliers with such credentials ensure traceability and legal compliance, critical for pharmaceutical licensing and import-export procedures.

Sourcing Challenges and Considerations

Regulatory Compliance

Given the controlled substance status of codeine, sourcing APIs demands rigorous adherence to domestic and international regulatory frameworks:

United States:
DEA registration is mandatory; importation requires strict documentation and license approval.
European Union:
Compliance with EMA and local controlled substance regulations applies, including stringent import/export licensing.
India and China:
Manufacturers must hold valid licenses for controlled substances, with export permits requisite for international trade.

Quality Assurance and Certification

Manufacturers should provide comprehensive batch records, Certificates of Analysis (CoA), and compliance with pharmacopeial standards such as USP, EP, and JP. Additional certifications like ISO 9001, cGMP, and WHO-GMP bolster credibility.

Pricing and Supply Chain Reliability

Asian API suppliers generally offer competitive pricing due to lower manufacturing costs. However, supply chain stability concerns, geopolitical factors, and logistical considerations (shipping restrictions, customs clearance) influence procurement planning.

Intellectual Property and Patent Considerations

While promethazine is off-patent globally, specific formulations may be patent-protected; however, bulk API sourcing remains unaffected. Codeine’s patent landscape varies, but regulatory restrictions often suffice to limit monopolistic practices.

Implications for Pharmaceutical Manufacturers

Due Diligence:
Vendors must undergo rigorous qualification processes, including audits and verification of compliance with current Good Manufacturing Practices (cGMP).
Risk Mitigation:
Developing multiple supply sources reduces risk associated with regulatory changes, political instability, or capacity constraints.
Regulatory Liaison:
Building strong relationships with national regulators facilitates smoother importation of controlled substances.
Pricing Strategies:
Leveraging Asian suppliers can optimize costs but necessitates assessment of quality, regulatory compliance, and long-term reliability.

Conclusion

The sourcing of bulk APIs for promethazine with codeine requires navigating a tightly regulated, complex supply landscape. Asian manufacturers, primarily in China and India, dominate the market, offering cost-effective, high-quality APIs for both promethazine and codeine, provided that strict compliance and quality standards are met. Pharmaceutical companies need to conduct due diligence, ensure regulatory compliance, and establish resilient supply chains to maintain consistent production of promethazine with codeine.

Key Takeaways

Asian manufacturers, mainly in China and India, lead global promethazine and codeine API production, offering cost advantages alongside quality considerations.
The controlled status of codeine necessitates strict regulatory compliance, licensing, and traceability throughout the supply chain.
Due diligence, including audits and certification verification, is critical for sourcing APIs suitable for pharmaceutical manufacturing.
Building diversified supplier relationships reduces risks associated with geopolitical, regulatory, or logistical disruptions.
Strong regulatory partnerships and quality assurance measures are essential for maintaining compliance and supply continuity.

Frequently Asked Questions

1. What are the primary regions for sourcing promethazine and codeine APIs?
China and India dominate API manufacturing for both promethazine and codeine, owing to their extensive chemical production infrastructure and cost advantages.

2. What regulatory considerations are critical when sourcing codeine APIs?
Manufacturers must hold appropriate controlled substance licenses, comply with local and international regulations (e.g., DEA registration in the US, NMPA in China), and ensure traceability and security throughout the supply chain.

3. How can quality assurance be verified with Asian API suppliers?
Through comprehensive Certificates of Analysis, audits, adherence to pharmacopeial standards, and certifications like cGMP, ISO, and WHO-GMP.

4. Are there geopolitical risks associated with sourcing APIs from Asia?
Yes. Political tensions, trade policies, or export restrictions can impact supply stability. Diversifying suppliers and maintaining good regulatory relationships mitigate such risks.

5. What are the key steps to establishing a reliable supply chain for promethazine with codeine APIs?
Conduct thorough supplier qualification, verify regulatory compliance, establish quality assurance protocols, ensure logistical planning, and develop contingency plans for supply disruptions.

References

U.S. Drug Enforcement Administration. (2022). Regulations on Controlled Substance APIs.
World Health Organization. (2011). Guidelines for Pharmaceutical Quality Assurance.
Han, J., & Liu, Y. (2020). Trends in Asian API Production. Pharmaceutical Technology Asia.
Indian Pharmacopoeia Commission. (2021). Standards for APIs.
European Medicines Agency. (2022). Regulation on Controlled Substances: Supply and Precursors.

Bulk Pharmaceutical API Sources for PROMETHAZINE WITH CODEINE