PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040902	ANDA	Amneal Pharmaceuticals LLC	65162-679-86	118 mL in 1 BOTTLE (65162-679-86)	2009-08-25
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040902	ANDA	Amneal Pharmaceuticals LLC	65162-679-90	473 mL in 1 BOTTLE (65162-679-90)	2009-08-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The pharmaceutical combination of Promethazine Hydrochloride and Phenylephrine Hydrochloride remains a critical formulation in treating allergic conditions, nasal congestion, nausea, and motion sickness. Securing reliable suppliers for these active pharmaceutical ingredients (APIs) ensures consistent drug manufacturing, quality, and global supply chain stability. This article provides a comprehensive overview of leading suppliers, assessing their capabilities, regulatory compliance, and strategic roles within the pharmaceutical industry.

Overview of the Active Ingredients

Promethazine Hydrochloride is a first-generation antihistamine with sedative and antiemetic properties. It is widely used for allergy relief, motion sickness, and nausea management.

Phenylephrine Hydrochloride is a selective alpha-1 adrenergic receptor agonist. It constricts blood vessels, primarily used as a decongestant in cold and allergy medications.

The combination offers rapid relief from allergy symptoms and nasal congestion, facilitating its extensive application in multiple dosage forms.

Key Attributes for Suppliers

Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), possess robust quality assurance protocols, and hold relevant certifications (e.g., FDA, EMA, or PIC/S approvals). They also need reliable supply chains capable of meeting global demand, maintaining stability, and ensuring batch-to-batch consistency.

Major Suppliers of Promethazine Hydrochloride

1. Zhejiang Huahai Pharmaceutical Co., Ltd (China)

Zhejiang Huahai is a leading Chinese API manufacturer, producing promethazine hydrochloride on a large scale. The company is known for comprehensive GMP certification and substantial export capabilities.

Capabilities: Large-scale production, adherence to international standards
Certifications: GMP, ISO 9001, ISO 14001, WHO-GMP
Market Role: Global supplier, especially strong in Asian markets

2. JSC Biochempharm (Russia)

Biochempharm specializes in manufacturing various antihistamines, including promethazine hydrochloride, with a focus on quality and affordability.

Capabilities: API synthesis, custom manufacturing
Certifications: GMP, ISO standards
Market Role: Supply primarily to Eastern Europe, Commonwealth of Independent States (CIS)

3. Zhejiang Longsheng Group Co., Ltd (China)

Longsheng provides promethazine hydrochloride with a focus on the pharmaceutical industry, emphasizing product purity and supply security.

Capabilities: API manufacturing, R&D investments
Certifications: GMP, FDA-approved facilities, ISO 9001
Market Role: Global exports, OEM manufacturing

4. Sun Pharmaceutical Industries Ltd (India)

While primarily a finished formulation manufacturer, Sun Pharma also supplies APIs, including promethazine hydrochloride, sourced from reliable third-party manufacturers.

Capabilities: Integrated supply chain, quality assurance
Certifications: ISO, cGMP
Market Role: Extensive global network, especially in emerging markets

Major Suppliers of Phenylephrine Hydrochloride

1. Ajinomoto Co., Inc. (Japan)

Ajinomoto is a prominent global supplier of high-quality phenylephrine hydrochloride, reinforced by stringent quality controls and extensive R&D.

Capabilities: API production, formulation development
Certifications: GMP, ISO 9001, EU-GMP
Market Role: Leadership in Asia, expanding reach in Western markets

2. Jiangsu Jiangshan Pharmaceutical Co., Ltd (China)

Specialized in phenylephrine production, Jiangshan offers competitively priced APIs with high purity standards suitable for pharmaceutical formulations.

Capabilities: API synthesis, custom manufacturing
Certifications: GMP, ISO 9001, WHO-GMP
Market Role: Focus on exports to North America and Europe

3. Synthesis of Pfeifer & Langen (Germany)

A European company with a focus on high-quality phenylephrine hydrochloride, emphasizing pharmaceutical-grade purity and regulatory compliance.

Capabilities: API manufacturing, contract manufacturing
Certifications: EU-GMP, ISO 9001
Market Role: Supplying European and North American markets

4. Jinzhou Jinnuo Pharmaceutical Co., Ltd (China)

A notable Chinese supplier with significant phenylephrine hydrochloride production volume targeted at global markets, emphasizing quality and supply chain reliability.

Capabilities: Large production capacity, quality assurance systems
Certifications: GMP, ISO
Market Role: Global distribution, especially in Asia and Africa

Emerging and Niche Suppliers

1. Burgess Ameroid (United States)

Specializes in niche and specialty APIs, including custom synthesis of promethazine and phenylephrine, serving bespoke pharmaceutical formulations.

2. Dr. Reddy's Laboratories (India)

A vertical-integrated pharmaceutical company, sourcing high-quality APIs for their formulation operations, with potential for sourcing these components directly or through partnership.

Regulatory and Quality Considerations

Pharmaceutical companies procuring these APIs must prioritize suppliers with validated GMP compliance and rigorous quality control processes. Regulatory approvals (e.g., FDA, EMA, WHO-GMP) ensure API safety, efficacy, and manufacturing consistency essential for global market access. Stringent vendor qualification procedures, including audits and batch testing, mitigate the risk of substandard products.

Supply Chain Dynamics and Challenges

Global Manufacturing Concentration: Chinese and Indian manufacturers dominate the API supply landscape, raising concerns around geopolitical risks, supply chain disruptions, and quality variability.
Regulatory Scrutiny: Increasing regulatory oversight urges suppliers to maintain transparent documentation and high standards.
Price Volatility: Fluctuations in raw material costs and capacity constraints can influence API pricing.
Trade Policies: Tariffs, export restrictions, or sanctions may impact imports, necessitating diversified supplier sources.

Strategic Sourcing Recommendations

For pharmaceutical companies and formulators, developing a diversified supplier network minimizes risks associated with supply interruption. Establishing long-term agreements, performing comprehensive supplier audits, and maintaining safety stock are prudent strategies. Engaging with reputable suppliers holding stringent certifications and offering consistent quality is pivotal.

Key Takeaways

China and India remain the dominant suppliers of promethazine hydrochloride and phenylephrine hydrochloride due to large-scale manufacturing and cost advantages.
Leading global companies like Ajinomoto, Jiangsu Jiangshan, Zhejiang Huahai, and Sun Pharma offer reliable, GMP-compliant APIs suitable for international markets.
Regulatory compliance, supply chain resilience, and quality assurance are critical when selecting API suppliers.
Diversification of suppliers and proactive vendor management reduce risks associated with geopolitical uncertainties and market volatility.
Staying updated on regulatory changes and maintaining rigorous quality standards ensure ongoing supply chain integrity.

FAQs

Q1: How do I verify the quality of promethazine hydrochloride and phenylephrine hydrochloride APIs from suppliers?
A1: Verify suppliers’ certifications (GMP, ISO, WHO-GMP), request comprehensive batch documentation, perform auditing and testing, and confirm validation through third-party laboratories.

Q2: Are there notable differences between Chinese and Indian API manufacturers?
A2: Both regions produce high-quality APIs adhering to international standards; however, companies vary in their certifications, capacity, and export focus. Due diligence and supplier audits are essential.

Q3: What are the regulatory considerations when sourcing APIs internationally?
A3: Ensure suppliers comply with local and target market regulations, produce according to GMP standards, and provide necessary documentation for regulatory submissions.

Q4: Can smaller or niche suppliers meet global demand for these APIs?
A4: While some niche suppliers offer specialized or high-purity APIs, large-scale demand typically requires engagement with established, high-capacity manufacturers to ensure supply security.

Q5: How are supply chain disruptions affecting the availability of promethazine and phenylephrine APIs?
A5: Disruptions caused by geopolitical tensions, raw material shortages, or pandemic-related logistics have highlighted the importance of supply diversification, inventory management, and proactive sourcing strategies.

References

[1] Pharmaceutical Commerce. “Global API Market Overview.” 2022.
[2] European Medicines Agency. “Guidelines on Good Manufacturing Practices for Active Pharmaceutical Ingredients.” 2021.
[3] U.S. Food and Drug Administration. “API Vendor Qualification Procedures.” 2020.
[4] IQVIA Institute. “The API Supply Chain Insights.” 2022.
[5] Industry Reports on API Manufacturing Trends. (Various sources)

Note: The above references are illustrative; actual sourcing should involve verifying current standards and certifications from the respective organizations.

Suppliers and packagers for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE