Bulk Pharmaceutical API Sources for PHENERGAN W/ CODEINE

Bulk Pharmaceutical API Sources for PHENERGAN W/ CODEINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-9C03651
RR Scientific		R6447395

Bulk Active Pharmaceutical Ingredient (API) Sources for PHENERGAN W/ CODEINE

Last updated: November 24, 2025

Introduction

Phenergan with Codeine, a combination of promethazine and codeine, is a prescription medication primarily used to treat severe cough and allergy symptoms. Due to its controlled substance status—owing to the presence of codeine—it demands strict regulatory oversight and precise sourcing of its Active Pharmaceutical Ingredients (APIs). Ensuring the integrity, quality, and supply chain stability of these APIs is critical for pharmaceutical manufacturers, distributors, and regulatory compliance. This article provides a comprehensive overview of bulk API sources for promethazine and codeine, emphasizing the current landscape, sourcing considerations, and industry best practices.

Regulatory Landscape and API Import Standards

APIs for medications like Phenergan with Codeine are subject to rigorous regulatory scrutiny under agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and counterparts globally. Sourcing from approved, reputable manufacturers is essential to meet Good Manufacturing Practice (GMP) standards, minimize contamination risk, and ensure batch-to-batch consistency.

API suppliers must provide Certificates of Analysis (CoA), demonstrating purity levels generally exceeding 99%, and full compliance with pharmacopeia standards such as USP, EP, or JP. For controlled substances like codeine, additional legal and regulatory requirements govern their importation, storage, and distribution.

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Key Sources of Promethazine API

1. Major Global API Manufacturers

• Sun Pharmaceutical Industries Ltd.
  An India-based industry leader with an extensive portfolio of APIs, including promethazine. Sun Pharma complies with international GMP standards and supplies to pharmaceutical companies worldwide, including North America and Europe.

• Jubilant Life Sciences
  Another prominent Indian API producer offering promethazine APIs. Jubilant's manufacturing units are GMP-certified, with export licenses to multiple countries.

• Hetero Labs Limited
  Known for producing a wide spectrum of APIs, Hetero offers promethazine with high purity suitable for injectable and oral formulations, complying with global quality standards.

• Glenmark Pharmaceuticals
  This company supplies promethazine APIs chiefly to markets in North America and Europe, adhering to stringent quality regulations.

• Zhejiang Jiuzhou Pharmaceutical Co., Ltd.
  A Chinese manufacturer producing promethazine API with GMP certification. Chinese API producers constitute a significant share of global supply, with increasing emphasis on quality assurance.

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2. North American and European API Suppliers

• Bachem AG
  Specializes in custom and catalog APIs. While primarily known for peptide synthesis, Bachem also sources or intermediates useful in API production.

• Xian Afsen Pharmaceutical Co., Ltd.
  Supplies promethazine APIs to European and North American markets. Their facilities meet EU-GMP standards and have robust quality documentation.

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3. Sourcing Considerations for Promethazine API

• Regulatory Compliance:
  Ensure supplier adherence to GMP, USP, EP, or JP standards. Verify their licenses through regulatory agencies and inspections.

• Purity & Quality Assurance:
  Suppliers should provide detailed Certificates of Analysis. Purity levels exceeding 99% are the industry standard, with clear impurity profiles.

• Supply Chain Reliability:
  Stability in supply is critical, particularly amid global disruptions. Evaluating supplier track records and capacity is essential.

• Legal & Controlled Substance Regulations:
  As codeine is a Schedule II controlled substance in the U.S. and class B in many countries, sourcing must comply with DEA, EMEA, and local regulations, including proper licensing and documentation.

• Documentation & Traceability:
  Detailed batch records, Certificates of Analysis, Material Safety Data Sheets (MSDS), and export licenses are vital for legal compliance and quality control.

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Sourcing of Codeine API

1. Notable Suppliers

• Durham Pharmaceuticals
  Provides pharmaceutical-grade codeine API with full GMP compliance for research and manufacturing purposes.

• Sun Pharmaceutical Industries Ltd.
  Supplies codeine API, adhering to international GMP standards, with extensive experience in controlled substances.

• Aurobindo Pharma Limited
  Offers codeine APIs for various formulations, with requisite security measures in place for controlled substances.

• Mallinckrodt Pharmaceuticals
  A prominent global provider of controlled APIs, including codeine, known for compliance with rigorous regulatory standards.

2. Sourcing & Regulatory Considerations

• Legal Restrictions:
  Due to the potential for misuse, importing and manufacturing codeine APIs entails strict licensing under local drug enforcement agencies.

• Quality and Security:
  Suppliers must have robust security measures to prevent diversion, with detailed documentation for legal and regulatory audits.

• Certification & Inspection:
  Prefer suppliers with recent GMP inspections and recognized certifications, such as ISO 9001, which underpin product integrity.

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Market Trends and Industry Dynamics

The global market for APIs like promethazine and codeine remains stable yet increasingly regulated. The rise of biosimilars and generics intensifies competition among suppliers, emphasizing the importance of strict quality management and regulatory vetting. Asian manufacturers, particularly from India and China, dominate the supply chain, driven by cost advantages and expanded capacity.

However, recent tightening of controls on controlled substances globally impacts sourcing logistics. Manufacturers are now more focused on establishing compliant, traceable supply chains and building relationships with trusted, audited manufacturers.

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Quality Assurance and Due Diligence

• Audits and Inspections:
  Regular audits of manufacturing facilities, particularly for APIs used in controlled substances, help verify GMP compliance.

• Supplier Qualification:
  A comprehensive qualification process should include on-site audits, review of regulatory history, and verification of certifications.

• Supply Agreements:
  Clearly define quality specifications, delivery timelines, documentation requirements, and compliance obligations to mitigate supply risks.

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Conclusion

Sourcing bulk APIs for Phenergan with Codeine—promethazine and codeine—requires meticulous supplier vetting, strict adherence to regulatory standards, and comprehensive quality assurance measures. Leading global API manufacturers from India, China, and established Western firms offer reliable sources, provided that companies perform thorough due diligence. Navigating the complex legislative landscape surrounding controlled substances demands specialized knowledge and secure, compliant supply chains.

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Key Takeaways

• Prioritize GMP-certified suppliers for promethazine and codeine APIs to ensure safety, efficacy, and regulatory compliance.
• Establish strong legal and contractual frameworks to facilitate compliant importation and distribution of controlled substances.
• Conduct rigorous supplier qualification through audits, documentation reviews, and ongoing monitoring.
• Adapt to regulatory shifts in controlled substance legislation to mitigate supply disruptions.
• Leverage global manufacturing hubs, notably India and China, while emphasizing quality assurance and traceability.

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FAQs

1. How do I verify the quality of promethazine API from a supplier?
Request Certificates of Analysis, review impurity profiles, and, if possible, conduct audits or third-party testing to ensure compliance with pharmacopoeial standards (USP, EP).

2. What regulatory considerations are involved in sourcing codeine API?
Codeine is a controlled substance, requiring proper licensing, compliance with DEA or equivalent authorities, and detailed documentation throughout the import and supply process.

3. Are there alternatives to traditional suppliers for promethazine?
Emerging manufacturers in India and China increasingly supply promethazine APIs, but due diligence remains critical to confirm GMP compliance and legal standing.

4. How can I mitigate risks of supply disruption for APIs?
Diversify suppliers across regions, establish long-term agreements, and maintain safety stock to buffer against disruptions.

5. What should a pharmaceutical company include in its supplier qualification process?
Assessment should cover GMP certification, regulatory inspection history, quality management systems, supply capacity, compliance with controlled substance regulations, and ongoing monitoring.

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References

1. U.S. Food and Drug Administration (FDA). Guidance for Industry: Registration of Drug Establishments and Drug Listing.
2. European Medicines Agency (EMA). Good Manufacturing Practice (GMP).
3. World Health Organization (WHO). Model Certificate of Pharmaceutical Product.
4. Indian Pharmaceutical Industry Reports (2022). API manufacturing landscape.
5. Controlled Substances Act (CSA). Legal guidelines for codeine distribution and import.