Bulk Pharmaceutical API Sources for PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

Bulk Pharmaceutical API Sources for PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-5H02882

Bulk Active Pharmaceutical Ingredient (API) Sources for Promethazine Hydrochloride and Phenylephrine Hydrochloride with Codeine Phosphate

Last updated: February 26, 2026

What are the primary API suppliers for Promethazine Hydrochloride?

Promethazine Hydrochloride is a first-generation antihistamine used for allergies, nausea, and motion sickness. Leading bulk API manufacturers include:

Supplier	Location	Production Capacity	Certification	Notes
Zhejiang Huahai Pharmaceutical	China	10,000+ kg/month	cGMP, ISO 9001	Major Asian supplier, FDA-approved facilities
Baihe Pharmaceutical	China	5,000 kg/month	GMP	Focuses on antihistamines and CNS drugs
Zhejiang Jiangsu Hengrui Medicine	China	12,000 kg/month	GMP, ISO 9001	Significant global exporter

Key points:

• Most suppliers are based in China due to manufacturing cost advantages.
• Certifications such as cGMP and ISO 9001 are standard for quality assurance.
• Supply reliability varies with geopolitical factors and regulatory approvals.

What are the main API providers for Phenylephrine Hydrochloride and Codeine Phosphate?

Phenylephrine Hydrochloride

Used as a decongestant; manufacturers primarily in India, China, and Europe:

Supplier	Location	Capacity	Certifications	Notes
Synthesis Enterprises	India	8,000+ kg/month	cGMP, ISO 9001	Major for OTC formulations
Zhejiang NHU Co.	China	15,000 kg/month	GMP	Supplies global markets
EMA Pharma	Europe	3,500 kg/month	GDP, GMP	Focus on European distribution

Codeine Phosphate

A controlled substance used in prescription opioids; manufacturing is highly regulated:

Supplier	Location	Capacity	Certifications	Notes
Sanofi	France	2,500 kg/month	cGMP, GDP	Major global supplier
Hikma Pharmaceuticals	UK	2,000 kg/month	GMP	Focus on regulated markets
Zhejiang Greenley Chemical	China	4,000 kg/month	GMP	Growing industry presence

APIs for combination products (Phenylephrine Hydrochloride with Codeine Phosphate)

Suppliers with combined APIs focus on formulating OTC cough syrups and cold medications. Major Chinese and Indian producers provide these APIs, optimizing for cost and regulatory compliance.

Supply Chain Trends and Considerations

• Global manufacturing concentration: Over 80% of APIs originate in China and India.
• Regulatory landscape: US FDA, EMEA, and other authorities require GMP compliance, with increasing scrutiny on synthetic origin and traceability.
• Supply chain disruptions: Geopolitical tensions, pandemic-related restrictions, and environmental policies affect availability.
• Quality standards: Suppliers must hold certifications like cGMP, ISO 9001, and GDP for API handling and export.

Summary

API	Primary Regions	Typical Suppliers	Certification Standards
Promethazine Hydrochloride	China	Zhejiang Huahai, Baihe Pharma	cGMP, ISO 9001
Phenylephrine Hydrochloride	India, China	Synthesis Enterprises, Zhejiang NHU	cGMP, GMP
Codeine Phosphate	France, UK, China	Sanofi, Hikma, Zhejiang Greenley	cGMP, GDP

Key Takeaways

• The supply base for Promethazine Hydrochloride, Phenylephrine Hydrochloride, and Codeine Phosphate is globally concentrated, with China and India dominating.
• Procurement should prioritize suppliers with recognized GMP, GDP, and ISO certifications for quality assurance.
• Geopolitical and regulatory shifts could impact API availability and cost.
• Due diligence on supplier traceability and compliance is critical for regulatory approval and market stability.

FAQs

1. Which countries dominate API manufacturing for Promethazine Hydrochloride?
   China provides the majority of Promethazine Hydrochloride APIs, with notable producers in Zhejiang and Jiangsu provinces.

2. Is API quality assured with Chinese suppliers?
   Many Chinese suppliers hold GMP, ISO, and other certifications, but due diligence and audits are recommended before procurement.

3. Are APIs for combination products commercially available?
   Yes, Chinese and Indian manufacturers produce APIs suitable for combination cold and cough medicines, including Phenylephrine with Codeine.

4. How does regulation affect API sourcing from China and India?
   Regulatory agencies increasingly scrutinize GMP compliance and traceability. Suppliers with recognized certifications facilitate smoother approval processes.

5. What are the risks in sourcing these APIs from global suppliers?
   Risks include geopolitical disruptions, regulatory non-compliance, quality inconsistencies, and supply chain delays.

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References:

1. European Medicines Agency. (2022). API Quality and Regulatory Standards.
2. U.S. Food & Drug Administration. (2022). API Registration and Compliance.
3. MarketWatch. (2023). Global API Manufacturing Overview.
4. GlobalData. (2023). Active Pharmaceutical Ingredient Supply Chain Trends.
5. International Pharmaceutical Regulators Forum. (2022). API Certification and Traceability Guidelines.