Bulk Pharmaceutical API Sources for PHERAZINE W/ CODEINE

Bulk Pharmaceutical API Sources for PHERAZINE W/ CODEINE

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

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

Last updated: August 4, 2025

Introduction

Phenerazine with Codeine, combining the antihistamine phenothiazine derivative with a narcotic analgesic, has historically served in symptomatic relief of allergy symptoms and cough suppression. As a Schedule V controlled substance in the United States, its production, distribution, and sourcing are tightly regulated. Ensuring reliable, compliant API sourcing is critical for pharmaceutical manufacturers and distributors to maintain product integrity, regulatory compliance, and patient safety. This report examines the current landscape of bulk API suppliers for Phenerazine with Codeine, emphasizing sourcing challenges, regulatory considerations, and global manufacturing trends.

Regulatory Framework and Market Overview

The synthesis and supply of APIs like phenothiazine derivatives and codeine are governed by stringent regulatory frameworks, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and similar authorities worldwide. As controlled substances, APIs comprising Phenerazine with Codeine require licenses and adherence to international narcotics control treaties, notably the United Nations Single Convention on Narcotic Drugs (1961) [1].

The global API market for narcotic and controlled substances is characterized by limited suppliers, high compliance costs, and stringent quality standards. North America, Europe, and select Asian countries dominate this landscape. The primary producers are usually integrated pharmaceutical companies or specialized API manufacturers operating under strict licensing regimes to ensure compliance with Good Manufacturing Practice (GMP) standards.

Major API Suppliers for PHERAZINE (Promethazine) and Codeine

1. Promethazine (Phenothiazine Derivative) API Suppliers

Promethazine, the active component of Pherazine, is primarily produced by a limited number of global chemical manufacturers. Key players include:

• Glenmark Pharmaceuticals (India): A notable API producer with GMP-certified facilities, Glenmark supplies promethazine sulfate for bulk pharmaceutical use, including formulations for antihistamine and antiemetic applications.
• DR. REDDY'S Laboratories (India): Known for its extensive API portfolio, DR. Reddy's offers promethazine shipments compliant with international standards.
• Hetero Labs (India): Active in manufacturing phenothiazine derivatives, Hetero maintains rigorous quality controls suitable for controlled substance APIs.
• Indo Amines Ltd (India): Specializes in pharmaceutical intermediates and APIs, including phenothiazine derivatives.

Indian manufacturers dominate the promethazine market due to cost competitiveness and robust GMP compliance, but export licenses and regulatory approvals are critically assessed before procurement.

2. Codeine API Suppliers

As a controlled narcotic, codeine API availability is limited to a small set of licensed manufacturers, primarily in regions with strong narcotics manufacturing standards, including India, China, and certain European countries.

• Sun Pharmaceutical Industries Ltd (India): A leading API producer with authorized licenses for codeine manufacturing, Sun Pharma supplies pharmaceutical companies globally.
• Xinjiang Guanghui Chemical (China): One of the largest codeine producers in China, operating under strict regulatory oversight.
• Mouser Pharmaceuticals Ltd (India): Compliant with international narcotics control regulations, providing bulk codeine base suitable for API use.
• Hubei Jinlong Chemical (China): An active narcotics API manufacturer with recent licensing updates.

Note: The sourcing of codeine APIs involves navigating complex narcotics control regulations. Manufacturers must ensure comprehensive licensing and compliance with international treaties.

Global Sourcing Trends and Challenges

a. Regulatory Compliance and Licensing

Given the controlled status of phenothiazine derivatives and codeine, suppliers must possess valid manufacturing and distribution licenses issued by authorities such as the Drug Enforcement Administration (DEA) in the U.S., the European Union’s EMA, or respective national agencies. Import/export restrictions, audit requirements, and serialization demand rigorous compliance.

b. Quality Assurance and GMP Standards

API manufacturers supplying Phenerazine with Codeine must adhere to GMP standards to ensure purity, potency, and batch-to-batch consistency. Pharmaceutical companies often favor suppliers with comprehensive quality management systems and batch documentation traceability.

c. Supply Chain Reliability

The narcotics nature of codeine introduces logistical complexities, including customs clearance and storage restrictions. Maintaining multiple qualified supply sources is essential to avoid shortages and ensure uninterrupted manufacturing.

d. Geopolitical and Economic Factors

Country-specific policies, tariffs, and trade agreements influence API sourcing. India and China remain dominant due to their manufacturing scale and cost advantages but face increasing scrutiny over quality standards and regulatory transparency.

Emerging Trends and Developments

1. Shift toward Vertical Integration

Major pharmaceutical firms increasingly integrate API manufacturing within their supply chain to reduce dependency on external vendors, enhance quality control, and secure regulatory approval.

2. Focus on Supply Chain Transparency

Stakeholders emphasize transparency and traceability, driven by regulations and quality assurance requirements, encouraging digital tracking, serialization, and compliance audits.

3. Expansion of Manufacturing Capacity

Dedicated narcotics API manufacturing facilities are expanding globally, especially in India and China, to meet rising demand while ensuring compliance with international control regimes.

4. Alternative Sourcing Strategies

Pharmaceutical firms explore regional diversification, including regulatory-approved suppliers in Africa and Southeast Asia, to mitigate geopolitical risks.

Due Diligence in API Acquisition

Sourcing bulk API for Phenerazine with Codeine demands rigorous vetting to ensure adherence to:

• Regulatory licenses and compliance documentation
• Quality Certifications (GMP, ISO)
• Traceability and batch documentation
• Robust testing data for purity, potency, and contaminants
• Effective supply chain management and logistics

Partnerships with reputable suppliers, often verified via third-party audits, are essential to mitigate risks associated with counterfeit or substandard APIs.

Conclusion

Securing reliable sources for bulk Phenerazine (Promethazine) and codeine APIs hinges on navigating complex regulatory environments, ensuring rigorous Quality Management System adherence, and establishing trustworthy supply relationships. The Indian and Chinese markets remain the primary hubs, supported by their extensive manufacturing capacity and cost advantages. However, companies must prioritize compliance, quality, and supply chain resilience in their procurement strategies.

Key Takeaways

• The supply of Phenerazine with Codeine APIs is tightly regulated due to narcotic classification, requiring strict licensing and compliance.
• India and China dominate the API manufacturing landscape but necessitate thorough due diligence regarding regulatory status and GMP adherence.
• Pharmaceutical firms should diversify supplier bases and prioritize supply chain transparency to mitigate potential shortages.
• Regulatory compliance, quality assurance, and rigorous testing are non-negotiable factors in API procurement for controlled substances.
• Emerging trends favor vertical integration and digital traceability, enhancing supply chain security and product integrity.

FAQs

1. Are there global restrictions on sourcing codeine APIs?
Yes. As a controlled narcotic, codeine API import and export are subject to international and national regulations, including licensing, documentation, and customs controls. Suppliers must hold valid narcotics licenses in their jurisdiction.

2. Can domestic manufacturers in non-regulated countries produce Phenerazine with Codeine APIs?
Production is generally limited to licensed manufacturers with proper narcotics licenses and GMP certification, mainly in India, China, and select regions. Non-regulated countries typically lack the licensing infrastructure needed.

3. How do regulatory agencies verify API quality from overseas suppliers?
Agencies conduct audits, review GMP certifications, and require batch testing data and Certificates of Analysis (CoA) to confirm quality and purity standards necessary for pharmaceutical application.

4. What are the primary challenges in sourcing controlled substance APIs globally?
Key challenges include regulatory compliance, licensing hurdles, logistical complexities, quality assurance demands, and geopolitical considerations impacting supply chain stability.

5. Are there synthetic alternatives to phenothiazine-based APIs like Phenerazine?
While alternative antihistamine and cough suppressant compounds exist, phenothiazine derivatives remain relevant in certain formulations. The choice depends on regulatory approvals and product specifications.

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Sources

[1] United Nations Office on Drugs and Crime. "Single Convention on Narcotic Drugs (1961)." Available at: https://www.unodc.org