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

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genus	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040654	ANDA	Genus Lifesciences Inc.	64950-345-16	473 mL in 1 BOTTLE, PLASTIC (64950-345-16)	2024-07-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

The pharmaceutical landscape for active pharmaceutical ingredients (APIs) such as Phenylephrine Hydrochloride and Promethazine Hydrochloride is highly scrutinized due to their widespread use in treatments for nasal congestion, allergies, and motion sickness. Reliable suppliers are essential for pharmaceutical companies to ensure product quality, regulatory compliance, and consistent supply. This article provides an in-depth analysis of key suppliers, global supply chains, and market dynamics for these APIs, offering critical insights for industry stakeholders.

Phenylephrine Hydrochloride: Market Overview and Supplier Landscape

Phenylephrine Hydrochloride, a sympathomimetic agent primarily used as a decongestant, has seen substantial demand in over-the-counter (OTC) medications. Its supply chain involves several regions, notably India, China, and Europe, which dominate manufacturing.

Leading Suppliers of Phenylephrine Hydrochloride

Delpha USA Inc.: Known for producing pharmaceutical-grade Phenylephrine HCl with stringent quality protocols. Their manufacturing facilities are compliant with cGMP standards, serving both domestic and international markets.
Shandong Xinhua Pharmaceutical Co., Ltd.: A Chinese manufacturer that supplies Phenylephrine HCl globally. It benefits from a robust supply chain and competitive pricing but faces regulatory scrutiny regarding quality compliance.
LGM Pharma: A global distributor of pharmaceutical ingredients, LGM Pharma sources Phenylephrine HCl from multiple manufacturers, offering supply chain flexibility for pharmaceutical developers.
Jubilant Pharmova: Based in India, Jubilant provides high-purity Phenylephrine HCl to the global market with a focus on quality assurance under ISO and cGMP standards.
Hanmi Pharmaceutical Co., Ltd.: South Korea-based, supplying both finished formulations and APIs, with a focus on quality and supply reliability.

Market Dynamics and Regulatory Considerations

The supply landscape for Phenylephrine is influenced by raw material sourcing (benzene derivatives), manufacturing capacity, and regulatory oversight. The U.S. FDA, European EMA, and other regulators enforce stringent standards, demanding supplier compliance. As regulatory environments tighten, companies seek suppliers who have undergone rigorous quality audits and possess GMP certifications.

Promethazine Hydrochloride: Market Overview and Supplier Landscape

Promethazine Hydrochloride is a phenothiazine derivative used primarily for allergies, motion sickness, and sedation. Its supply chain is more complex due to its chemical nature and stricter regulatory scrutiny.

Key Suppliers for Promethazine Hydrochloride

Sichuan Kelun Pharmaceutical Co., Ltd.: A major Chinese manufacturer with extensive production capacity, supplying to both generic and branded pharmaceutical firms globally. Their API meets international standards, with multiple certifications.
Sandoz (Novartis): Offers high-quality Promethazine HCl via their global network, emphasizing compliance with strict quality standards and offering reliable supply chains.
Cipla Limited: An Indian pharmaceutical powerhouse, Cipla supplies Promethazine HCl with a focus on quality, affordability, and FDA-certified manufacturing.
Mingtai Pharmaceutical: Chinese manufacturer with ISO-certified production facilities; supplies to various markets, especially in Asia and Africa.
BASF SE: Though predominantly an ingredient supplier for other chemical intermediates, BASF also supplies pharmaceutical-grade intermediates relevant for Promethazine synthesis.

Supply Chain Challenges and Opportunities

The supply chain for Promethazine is sensitive to regulatory updates, particularly regarding its classification as a phenothiazine derivative with central nervous system activity. Manufacturers must ensure compliance with international standards, including USP and EP monographs. Disruptions in China and India due to geopolitical issues or regulatory crackdowns can impact supply stability.

Regional Supply Dynamics and Emerging Trends

India and China: The dominant suppliers for both Phenylephrine and Promethazine, leveraging cost-effective manufacturing and large-scale production capacities.
Europe and North America: Focus on high-quality, GMP-compliant suppliers with comprehensive regulatory documentation. Many European companies also serve as contract manufacturing organizations (CMOs) providing APIs under strict quality controls.
Supply Chain Resilience: With recent disruptions caused by global trade tensions, COVID-19, and regulatory shifts, companies increasingly look for diversified sourcing strategies to mitigate risks.

Regulatory and Quality Considerations

Suppliers must adhere to international standards such as USP, EP, and JP monographs for APIs. Certifications like GMP, ISO 9001, and cGMP are critical selection criteria, ensuring batch-to-batch consistency and regulatory acceptability. Due diligence involves audits, batch testing, and supplier qualification processes.

Future Outlook and Market Opportunities

With the growing demand for OTC medications, particularly in emerging markets, the demand for Phenylephrine and Promethazine APIs will likely sustain or increase. Manufacturers investing in manufacturing capacity expansion, quality enhancement, and regulatory compliance will be better positioned to capture market share.

Key Considerations for Buyers

Prioritize suppliers with validated GMP certifications and quality assurance protocols.
Diversify supplier base to mitigate geopolitical and supply chain risks.
Monitor regulatory updates pertinent to phenothiazine derivatives and decongestants.
Engage in collaborative testing and quality audits.

Key Takeaways

Market Concentration: India and China dominate as primary suppliers for Phenylephrine and Promethazine APIs due to cost advantages and manufacturing scale.
Quality and Compliance: Due diligence is paramount; GMP certification and adherence to international standards are non-negotiable.
Supply Chain Resilience: Diversification and strategic partnerships mitigate geopolitical and logistical risks.
Regulatory Environment: Staying abreast of evolving global regulations ensures uninterrupted supply and market access.
Growth Opportunities: Rising demand in emerging markets and the expanding OTC segment support continued API demand growth.

FAQs

1. Who are the leading global suppliers of Phenylephrine Hydrochloride?
Top suppliers include Delpha USA Inc., Shandong Xinhua Pharmaceutical Co., Ltd., and Jubilant Pharmova, known for their GMP-compliant manufacturing and global distribution networks.

2. Which regions are the primary sources of Promethazine Hydrochloride APIs?
China and India are the primary sources, with manufacturers like Sichuan Kelun Pharmaceutical and Cipla supplying globally, supported by regulatory oversight for quality.

3. What are the key quality considerations when selecting a Phenylephrine or Promethazine API supplier?
Ensuring GMP certification, compliance with USP/EP standards, recent audit reports, and batch testing results are critical for quality assurance.

4. How are supply chain disruptions affecting these APIs?
Disruptions due to geopolitical tensions, COVID-19 related restrictions, and regulatory crackdowns have underscored the importance of diversified sourcing strategies.

5. What trends are shaping the future supply of Phenylephrine and Promethazine APIs?
Increasing demand for OTC medications, regulatory tightening, and manufacturing capacity expansion are shaping supply dynamics, with an emphasis on quality and resilience.

References

[1] U.S. Food and Drug Administration. (2022). GMP Regulations of Active Pharmaceutical Ingredients. FDA.
[2] European Medicines Agency. (2022). Guidelines on API Quality Standards. EMA.
[3] IQVIA Institute. (2022). The Rising Role of APIs in Global Pharmaceutical Supply Chains.
[4] MarketWatch. (2022). Global Phenylephrine Hydrochloride Market Analysis.
[5] Global Industry Analysts. (2021). Phenothiazine Derivatives Market Report.

Suppliers and packagers for PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE