PROMETH VC W/ CODEINE pharmaceutical API fine chemical suppliers

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Last updated: August 3, 2025

Introduction

Prometh VC W/ Codeine combines promethazine, an antihistamine, with codeine, an opioid analgesic, often formulated with an expectorant for respiratory indications. As a controlled substance with strict regulatory oversight, sourcing the active pharmaceutical ingredients (APIs)—promethazine and codeine—is complex, requiring compliance with international drug laws and quality standards. This report provides an exhaustive overview of reputable bulk API sources for promethazine and codeine, essential for manufacturers, distributors, and regulatory authorities aiming to ensure drug safety, efficacy, and regulatory compliance.

Regulatory Landscape and Operational Considerations

The procurement of APIs for formulations like PROMETH VC W/ Codeine entails navigating regulatory frameworks enforced by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and corresponding national authorities. APIs must adhere to Good Manufacturing Practices (GMP), demonstrate batch consistency, purity, and stability.

Because codeine is a controlled substance (Schedule II in the U.S.), suppliers must possess necessary licenses and documentation. Promethazine, while not controlled in many jurisdictions, still requires quality assurance. Global API sourcing often involves international manufacturers with validated facilities, comprehensive quality assurance protocols, and reliable logistics capabilities.

Major API Suppliers for Promethazine and Codeine

1. Promethazine API Suppliers

a. Sourcing from China

China remains a dominant supplier of pharmaceutical APIs, including promethazine, owing to large-scale manufacturing capacity and cost advantages.

Hefei United Chemistry Industry Co., Ltd.
- Recognized for GMP-compliant promethazine tablets and raw APIs.
- Offers high-purity promethazine HCl suitable for pharmaceuticals.
- Website: hefeiunitedchem.com
Jiangsu Hualun Pharmaceutical Co., Ltd.
- Supplies promethazine API with documented batch records, validated purity (>99%), and stability data.
- CAPA and documentation align with international standards.
- Contact through global API sourcing platforms.

b. Suppliers in India

India offers a significant base of validated pharmaceutical API manufacturers, often providing competitive pricing and robust quality standards.

Sun Pharmaceutical Industries Ltd.
- Produces a range of APIs, including promethazine HCl.
- Complies with WHO-GMP standards.
- Verified supplier with documented QC data.
Cipla Limited
- Offers promethazine APIs for export markets.
- Adheres to international quality standards and provides certification.

2. Codeine API Suppliers

a. China-Based Suppliers

North China Pharmaceutical Group Corporation (NCPC)
- Major producer of codeine base and phosphate salts.
- Demonstrates compliance with USP, EP, and JP standards.
- Provides bulk API with detailed batch documentation.
Shandong Yuanda Pharmaceutical Co., Ltd.
- Supplies pharmaceutical-grade codeine API.
- Regularly audited for GMP compliance.

b. Indian Manufacturers

Abbott India Ltd. (Now part of Sun Pharma)
- Produces codeine API with ISO-certified manufacturing facilities.
- Established track record for supply chain reliability.
Cipla Ltd.
- Offers codeine in various salt forms, including phosphate and sulfate.
- Validated manufacturing processes meeting international standards.

c. Alternative Sources

Other regional suppliers include suppliers in Eastern Europe, South America, and Africa, often offering competitive pricing but requiring rigorous quality validation.

Quality and Compliance Considerations

GMP Certification: Critical for APIs intended for pharmaceutical use.
Certifications: Certificates of Analysis (CoA), Certificate of Suitability (CEP), and Drug Master Files (DMF).
Purity Standards: Promethazine and codeine APIs should meet pharmacopeial standards (USP, EP, JP). Typical purity >99%, low residual solvents, and absence of contaminants.
Controlled Substance Registration: Given codeine's regulatory classification, suppliers must hold licensing for controlled substance manufacturing and export.

Key Challenges in Sourcing APIs

Regulatory Restrictions: Export controls, classifications, and import licenses vary significantly between countries.
Supply Chain Security: Risks include counterfeit APIs, supply disruptions, and quality variances.
Pricing and Lead Times: Competitive pricing often depends on order volume and supplier relationships, while lead times are influenced by regulatory clearance and manufacturing schedules.

Emerging Trends in API Sourcing

Vertical Integration: Increasing vertical integration by pharmaceutical companies to control API quality and supply security.
API Validation Technologies: Use of advanced analytical techniques (HPLC, GC-MS) for batch validation.
Sustainable Sourcing: Focus on environmentally sustainable manufacturing practices and reducing carbon footprints.

Conclusion

Sourcing API for PROMETH VC W/ Codeine requires meticulous validation of suppliers' regulatory status, compliance standards, and quality assurance processes. Chinese and Indian manufacturers constitute primary sources given their extensive manufacturing capacities and validated product offerings. However, due diligence in verifying certifications and regulatory adherence remains paramount.

Key Takeaways

Regulatory Compliance Is Paramount: Only choose suppliers with established GMP certifications and necessary controlled substance licenses.
Prioritize Quality and Certification: Request detailed Certificates of Analysis, stability data, and regulatory approvals.
Due Diligence for Controlled Substances: Given the controlled status of codeine, ensure supply chain security and regulatory clearance.
Leverage Global Sourcing Networks: Diversify suppliers to mitigate risks associated with geopolitical and logistical challenges.
Monitor Regulatory Changes: Stay informed about evolving drug laws impacting API import/export, especially for controlled substances.

FAQs

1. What are the primary regulatory considerations when sourcing APIs for PROMETH VC W/ Codeine?
Regulatory considerations include GMP compliance, licensing for controlled substances (particularly for codeine), documentation such as CoA and DMF submissions, and adherence to import/export controls dictated by authorities like the DEA (U.S.) or EMA (Europe).

2. Are Chinese API manufacturers trustworthy for promethazine and codeine?
Many Chinese manufacturers are GMP-certified and compliant with international standards. Due diligence, including audits and certification verification, is essential to ensure quality and regulatory compliance.

3. How can I verify the purity of an API batch?
Request comprehensive Quality Certificates, perform independent laboratory testing (HPLC, GC-MS), and ensure batch-specific Certificates of Analysis detail purity, residual solvents, and impurity profiles.

4. What are the risks associated with sourcing APIs from emerging markets?
Risks include inconsistent quality, potential regulatory non-compliance, intellectual property concerns, and logistical delays. Robust supplier validation and audits mitigate these risks.

5. How do supply chain disruptions impact API sourcing for controlled substances?
Disruptions can lead to shortages, delays, and regulatory issues. Diversifying suppliers, maintaining safety stock, and establishing early communication channels are vital mitigation strategies.

References

[1] U.S. Food and Drug Administration (FDA). Drug Sourcing and Import Regulations. 2022.
[2] European Medicines Agency (EMA). Good Manufacturing Practice (GMP) Guidelines. 2022.
[3] WHO Expert Committee on Specifications for Pharmaceutical Preparations. WHO Technical Report Series, 2021.
[4] International Narcotics Control Board. Report on Global Opioid Supply Chain. 2022.
[5] Pharmeuropa. API Quality Standards for Promethazine and Codeine. 2022.

Note: Suppliers and standards mentioned are for illustrative purposes; potential buyers should conduct due diligence for current certifications and compliance.

Disclaimer: This document is for informational purposes only. It does not substitute for professional regulatory advice or due diligence when sourcing APIs.

Bulk Pharmaceutical API Sources for PROMETH VC W/ CODEINE