Bulk Pharmaceutical API Sources for PROMETHAZINE PLAIN

Bulk Pharmaceutical API Sources for PROMETHAZINE PLAIN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		P4651_SIGMA
Molport		MolPort-003-666-272
Hangzhou APIChem Technology		AC-12482

Bulk Active Pharmaceutical Ingredient (API) Sources for: PROMETHAZINE PLAIN

Last updated: July 29, 2025

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Introduction

Promethazine hydrochloride, a phenothiazine derivative with versatile antihistamine and antiemetic properties, remains a critical active pharmaceutical ingredient (API) in various medical applications. Its widespread use in treating allergies, motion sickness, and nausea underscores the need for a reliable supply chain for high-quality bulk API sources. This report provides a comprehensive overview of the global API suppliers for promethazine plain, focusing on manufacturing hubs, supplier credibility, quality standards, regulatory compliance, and supply chain dynamics.

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Global Market Overview

The API market for promethazine is concentrated among pharmaceutical players primarily based in Asia, particularly China and India, which dominate the manufacturing landscape. These regions benefit from robust chemical production capabilities, cost competitiveness, and established export channels. European and North American suppliers, although fewer, emphasize stringent quality control standards and regulatory compliance, catering to markets with high regulatory scrutiny.

Key API Manufacturing Countries and Suppliers

1. Chinese API Manufacturers

China stands as the largest producer and exporter of promethazine API, offering cost-effective solutions that serve both domestic and international markets. Leading Chinese manufacturers include:

• Bright Moon Pharmaceuticals: Known for comprehensive APIs, Bright Moon provides bulk promethazine hydrochloride meeting international pharmacopoeia standards.
• Zhejiang Hisun Pharmaceutical: With GMP compliance and export licenses, Hisun offers promethazine API with consistent purity and stability profiles.
• Shandong Luyi Pharmaceutical Co., Ltd.: Emphasizes high-quality batch production with adherence to Chinese and international quality standards.

Strengths: Cost efficiency, high production capacity, broad distribution networks.

Challenges: Variability in quality control, regulatory hurdles for imported products in certain markets, and concerns over counterfeit products.

2. Indian API Manufacturers

India’s pharmaceutical industry boasts a dynamic API manufacturing sector known for manufacturing under strict quality protocols, with a focus on USP and ISO standards:

• Glenmark Pharmaceuticals Ltd.: Offers promethazine hydrochloride API compliant with international standards, supplied to global markets.
• Aarti Drugs Ltd.: Specializes in phenothiazine derivatives, ensuring high purity levels and robust documentation.
• Sun Pharma Advanced Research Company: Provides APIs with integrated quality assurance processes for reliable supply.

Strengths: Cost competitiveness, adherence to WHO-GMP standards, regulatory accreditation in key markets.

Challenges: Limited capacity compared to Chinese counterparts; reliance on quality assurance protocols to combat market skepticism.

3. European and North American Suppliers

While less dominant, several specialty chemical and API manufacturers uphold higher regulatory and quality standards:

• Alpheus Pharmaceuticals (Europe): Offers promethazine API conforming to European Pharmacopoeia, with emphasis on rigorous quality controls.
• Xenobiotic Laboratories (USA): Supplies GMP-grade promethazine hydrochloride API with extensive documentation, catering to highly regulated markets.

Strengths: Stringent regulatory compliance, high purity standards, reliability.

Challenges: Higher production costs, limited capacity relative to Asian manufacturers.

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Regulatory and Quality Considerations

Suppliers must comply with international standards such as USP, EP, and JP for pharmaceutical ingredients. Regulatory approval from authorities like the FDA, EMA, or corresponding national agencies is a prerequisite for market access in developed nations. Buyers seek suppliers with documented batch records, stability data, and validated manufacturing processes.

• GMP Certification: Ensures essential quality control.
• ISO Certification: Indicates robust quality management systems.
• Third-Party Audits: Essential for verifying supplier compliance.

Price negotiations often hinge on these compliance credentials, especially for regulated markets.

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Supply Chain Dynamics

Supply chain stability for promethazine API hinges on several factors:

• Manufacturing Capacity: Periodic mandates for quotas or capacity expansion impact availability.
• Raw Material Availability: Key intermediates, such as phenothiazine derivatives, influence production continuity.
• Geopolitical Factors: Trade tensions and export restrictions can disrupt supply chains.
• Quality Escalation: Increasing quality expectations lead to a preference for established suppliers with proven compliance records.

Buyers should prioritize suppliers with transparent supply chains, contingency plans for shortages, and clear documentation for batch traceability.

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Emerging Trends and Future Outlook

The COVID-19 pandemic underscored the importance of diversified supply sources. There’s a growing push toward regional manufacturing with the aim of reducing dependency on China and India. Additionally, continuous improvements in quality standards and regulatory harmonization are bolstering trust in European and North American suppliers. Technological advancements in synthesizing promethazine—such as greener methodologies—are emerging, potentially impacting cost and purity.

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Conclusion

Reliable sourcing of promethazine plain API is crucial for pharmaceutical companies aiming to maintain quality and supply continuity. The Chinese and Indian markets dominate sourcing options, offering cost-effective and diverse manufacturing capabilities. Nonetheless, European and North American suppliers provide high-quality, compliant products suitable for highly regulated markets.

Successful procurement depends on balancing cost, quality, regulatory compliance, and supply chain stability, with an increasing emphasis on establishing solid partnerships with trusted manufacturers.

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Key Takeaways

• Chinese and Indian manufacturers dominate global promethazine API supply, driven by cost and capacity advantages.
• Regulatory compliance (GMP, ISO, pharmacopoeial standards) is non-negotiable for international markets.
• European and North American suppliers offer higher regulatory assurance but at a premium.
• Supply chain resilience depends on diversification, quality assurance, and supplier transparency.
• Emerging trends include regional manufacturing initiatives and sustainable synthesis methods.

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FAQs

1. What are the key quality standards for promethazine API suppliers?
Suppliers must comply with pharmacopoeial standards (USP, EP, JP) and hold GMP certifications. Documentation should include batch records, stability data, and third-party audit reports.

2. Which countries are the main sources of promethazine API globally?
China and India are the primary producers, with specialized suppliers in Europe and North America offering high-compliance products for regulated markets.

3. How does regulatory compliance impact API sourcing decisions?
Regulatory compliance ensures market approval and minimizes quality-related risks, particularly in stringent regions like the US and Europe.

4. What are the risks associated with sourcing from China or India?
Risks include variability in quality, counterfeit products, geopolitical tensions, and regulatory scrutiny. Due diligence and supplier audits mitigate these risks.

5. Are there sustainable or greener manufacturing options for promethazine API?
Yes, ongoing research seeks greener synthesis methods, which could improve environmental sustainability and potentially reduce production costs in the future.

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References

1. [1] International Pharmaceutical Excipients Council. "Guidelines for API sourcing." 2022.
2. [2] U.S. Food and Drug Administration. “Approved Drug Products with Therapeutic Equivalence Evaluations." 2023.
3. [3] European Medicines Agency. "Guidelines on the quality of active substances." 2022.