PHERAZINE VC W/ CODEINE bulk active fine chemical vendors

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Starshine Chemical	⤷ Get Started Free	2023-05-5H02882	⤷ Get Started Free
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Last updated: August 9, 2025

Introduction

Pherazine VC W/ Codeine represents a combination pharmaceutical product comprising promethazine (antihistamine and antiemetic), phenylephrine (decongestant), and codeine (opioid analgesic and cough suppressant). As a prescription medication used for symptomatic relief of coughs, colds, and allergic reactions, sourcing high-quality APIs—particularly promethazine and codeine—is critical for manufacturers. This report delineates the primary global sources for these APIs, considering regulatory compliance, quality standards, and supply stability.

Global Landscape for API Sourcing

1. Promethazine API Supply Dynamics

Promethazine hydrochloride, the active component in Pherazine VC W/ Codeine, is predominantly manufactured in firms across India, China, and a handful of Western countries. Indian and Chinese manufacturers dominate the market through established capacities, cost advantages, and extensive distribution networks.

a. Indian API Manufacturers

India’s pharmaceutical sector is a significant API supplier, with regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) and compliance with international standards (such as PIC/S, WHO GMP). Leading Indian API producers include:

Macleods Pharmaceuticals
Aarti Industries
Hetero Labs
Lloyds Pharmaceuticals

These companies supply promethazine hydrochloride with certifications aligned with U.S. FDA and EMA standards. Their production involves stringent quality control, ensuring API purity, potency, and batch-to-batch consistency.

b. Chinese API Manufacturers

China's API industry offers substantial capacity for promethazine production, often at competitive prices. Notable players include:

Shandong Haihua Pharmaceutical Co.
Sino Bioway Group
Qingdao Seastar Chemicals

Chinese APIs are increasingly meeting international quality benchmarks, driven by compliance initiatives and audits from global agencies. However, buyers should perform rigorous due diligence regarding regulatory compliance and quality management systems.

2. Codeine API Supply Dynamics

Codeine, a controlled opiate, faces more stringent regulatory controls. Its manufacturing is concentrated mainly in India, China, and certain European countries.

a. Indian Codeine Manufacturers

India remains a global leader in codeine API production, fulfilling both domestic and export demands. Key manufacturers include:

Sun pharma Advanced Research Company
Gufic Biosciences
Granules India

These firms produce codeine phosphate and bitartrate forms, often following stringent Indian and international licensing standards. Indian codeine APIs are approved for export to markets like the US, EU, and WHO jurisdictions.

b. Chinese Codeine Producers

Chinese manufacturers supply large quantities of codeine API, primarily to Asian markets, with some exports to global markets. Chinese production facilities are increasingly attaining GMP certification, bolstered by international audits.

c. Regulatory Considerations

Due to the controlled nature of codeine, sourcing mandates strict adherence to import/export regulations, especially in jurisdictions such as the US (DEA controlled substances) and EU (EMEA regulations). Suppliers with reputable compliance credentials are critical.

Key Criteria for API Supplier Selection

Regulatory Compliance: Suppliers must adhere to cGMP, ISO certifications, and possess regulatory approvals (e.g., FDA, EMA, TGA, PMDA).
Quality Assurance: Certificates of Analysis (CoA), stability data, and batch consistency.
Supply Chain Stability: Capacity for large-volume, reliable deliveries.
Pricing Structure: Competitive pricing with transparent documentation.
Traceability and Transparency: Robust documentation on manufacturing processes, origin, and Quality Management Systems (QMS).

Emerging API Suppliers and Alternatives

While traditional sources dominate, some emerging API manufacturers in Southeast Asia and Eastern Europe are seeking GMP certification and compliance, expanding options for pharmaceutical companies seeking diversified supply chains.

Regulatory and Legal Considerations

Purchasers must navigate complex regulatory landscapes, especially for controlled substances like codeine. Import licenses, controlled substance permits, and adherence to international drug control treaties (e.g., UN Drug Control Convention) are prerequisites. Engaging with suppliers experienced in these regulatory processes mitigates risk.

Supply Chain Challenges

Quality Variability: Differing standards across manufacturers can impact API quality.
Regulatory Changes: Stricter global controls over opioids influence codeine availability.
Sourcing Risks: Political or geopolitical tensions may disrupt supply chains, underscoring the need for dual sourcing strategies.

Conclusion

Reliable bulk sourcing of promethazine and codeine APIs requires navigating a landscape marked by regulatory complexity, quality assurance standards, and geopolitical factors. India and China remain the primary sources, with Indian manufacturers offering robust GMP compliance and global acceptance, whereas Chinese suppliers provide competitive pricing but require thorough due diligence.

Key Takeaways

Prioritize suppliers with recognized GMP, ISO certifications, and proven compliance with international standards.
Due to regulatory controls, especially over codeine, establish clear pathways for import licensing and legal compliance.
Diversify sourcing sources to mitigate risks associated with geopolitical or regulatory disruptions.
Conduct rigorous quality audits and request comprehensive documentation before procurement.
Stay current with evolving regulations concerning controlled substances to ensure uninterrupted supply and legal adherence.

FAQs

1. What are the main regions producing promethazine and codeine APIs?
India and China dominate API production, with India leading in promethazine, and both countries supplying significant volumes of codeine. Their manufacturing sectors are supported by regulatory frameworks ensuring compliance with international standards.

2. How do I ensure the quality of APIs sourced from emerging manufacturers?
Verify certifications such as cGMP, ISO, and regulatory approvals (FDA, EMA), request detailed Certificates of Analysis, conduct on-site audits if feasible, and establish strong quality management and supply chain transparency.

3. Are there regulatory hurdles for importing APIs containing controlled substances like codeine?
Yes. Importing controlled substances requires licenses, import permits, and adherence to international drug control treaties. Collaborate with experienced importers and ensure all legal documentation aligns with local/national laws.

4. How do geopolitical factors influence API sourcing?
Political tensions, trade restrictions, and regional stability can affect supply chains. Diversified sourcing and establishing relationships with multiple, reputable suppliers reduce vulnerability.

5. What certifications should I look for in a reliable API supplier?
Look for cGMP compliance, ISO 9001/ISO 13485 (if applicable), regulatory approvals (FDA, EMA), and proven track records of quality assurance and product consistency.

References

[1] U.S. Food and Drug Administration. (2022). "API Manufacturing Guidelines."
[2] European Medicines Agency. (2022). "Good Manufacturing Practice (GMP) Guidelines."
[3] International Narcotics Control Board. (2022). "Report on the Global Market for Controlled Substances."
[4] Indian Pharmaceutical Association. (2022). "Overview of API Manufacturing in India."
[5] China Pharmaceutical Industry Association. (2022). "Standards and Practices in API Production."

Bulk Pharmaceutical API Sources for PHERAZINE VC W/ CODEINE