Bulk Pharmaceutical API Sources for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1206772
THE BioTek		bt-1545528
RR Scientific		R4791547

Bulk Active Pharmaceutical Ingredient (API) Sources for Doxylamine Succinate and Pyridoxine Hydrochloride

Last updated: November 16, 2025

Introduction

The pharmaceutical industry relies heavily on the sourcing of high-quality Active Pharmaceutical Ingredients (APIs) to ensure the efficacy, safety, and consistency of medications. Doxylamine succinate and pyridoxine hydrochloride are two widely used APIs, often combined in formulations to treat various conditions such as nausea, sleep disorders, and vitamin B6 deficiency. Securing reliable bulk sources for these APIs is crucial for pharmaceutical manufacturers, regulatory compliance, and cost management. This report provides an in-depth analysis of the global API sourcing landscape for doxylamine succinate and pyridoxine hydrochloride, highlighting key suppliers, manufacturing hubs, quality considerations, and industry trends.

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Doxylamine Succinate: API Overview and Sourcing Landscape

Chemical Profile and Indications

Doxylamine succinate is an antihistamine with sedative properties, primarily used for short-term treatment of insomnia and as an antiemetic component in combination therapies for nausea during pregnancy (e.g., in OTC formulations like Diclegis). Its chemical formula is C17H22ClN3O·C4H6O4, with a molecular weight of approximately 371.87 g/mol.

Major API Manufacturers and Suppliers

Global Players and Production Hubs:
Major manufacturers of doxylamine succinate operate predominantly from countries with established pharmaceutical sectors, including India, China, the United States, and European nations.

• India: India stands out as a significant source due to its robust generic API manufacturing industry. Companies such as Divi's Laboratories, Suven Life Sciences, and Cipla produce high-grade doxylamine succinate APIs, exporting globally under strict quality regulations.

• China: Chinese API manufacturers like North China Pharmaceutical Group and Sino Biopharmaceutical supply bulk APIs at competitive prices but face scrutiny regarding regulatory compliance and quality consistency.

• United States/Europe: North American and European companies primarily operate as API developers and integrators, with some manufacturing for niche or specialty formulations, often supplying APIs under cGMP conditions to ensure regulatory approval readiness.

API Sourcing and Supply Chain Dynamics

The sourcing chain for doxylamine succinate is characterized by:

• OEM and Contract Manufacturing: Many pharmaceutical companies outsource API production to Contract Manufacturing Organizations (CMOs) which offer large-scale, cGMP-compliant facilities.

• Quality and Regulatory Compliance: Suppliers adhering to US FDA, EMA, and DMF (Drug Master Files) regulations are preferred. Quality certifications such as ISO 9001, cGMP, and WHO-GMP are critical selection criteria.

• Pricing Trends: Due to the mature manufacturing process, doxylamine succinate APIs are generally economical, with prices varying based on supplier quality and batch size.

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Pyridoxine Hydrochloride: API Overview and Sourcing Landscape

Chemical Profile and Indications

Pyridoxine hydrochloride, or vitamin B6, is essential for amino acid metabolism, neurotransmitter synthesis, and hemoglobin production. It is widely used in vitamin supplements and as an adjunct in treating neurological and metabolic disorders. The chemical formula is C8H10ClNO2, with a molecular weight of 205.64 g/mol.

Major API Manufacturers and Suppliers

Leading Countries and Companies:
The API market for pyridoxine hydrochloride is extensive with diverse sourcing options.

• India: India dominates the global supply with chemical giants such as Shivam Rasayan, Glenmark Pharmaceuticals, and Sandoz manufacturing high-quality pyridoxine hydrochloride APIs. Indian APIs offer competitive pricing, high purity standards, and are often produced under WHO-GMP approvals.

• China: Chinese manufacturers like Jiangsu Nhwa Pharmaceutical Co. and North China Pharmaceutical Group are significant contributors to the supply of pyridoxine APIs, providing cost-effective options.

• Europe and North America: These regions primarily focus on high-end, GMP-certified APIs, often for export to developed markets, often with stricter testing and validation standards.

Sourcing Considerations and Industry Trends

• Quality Assurance: Suppliers with validated processes, comprehensive documentation, and adherence to pharmacopoeial standards (USP, EP, JP) are favored.

• Supply Stability: Given the high demand for vitamin B6 globally, especially from nutraceutical sectors, sourcing partnerships emphasize consistent supply and regulatory documentation.

• Regulatory Pathways: International suppliers with established filing capabilities (e.g., DMFs, EDMFs) cater better to markets like the US and Europe, facilitating smoother approval processes.

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Comparative Analysis of API Sources

Aspect	Doxylamine Succinate	Pyridoxine Hydrochloride
Major producing countries	India, China, USA, Europe	India, China, Europe, North America
Leading manufacturers	Divi’s Laboratories, Cipla, Suven, North China Pharma	Shivam Rasayan, Glenmark, Jiangsu Nhwa
Quality standards	cGMP, WHO-GMP, DMF filings	cGMP, WHO-GMP, comprehensive validation
Pricing competitiveness	Moderate, depends on supplier quality	Competitive, high-volume market focus
Regulatory compliance	High, with emphasis on regulatory filings	High, especially for markets with strict regulations

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Industry Trends and Future Outlook

Market Trends

• Regulatory Scrutiny: Increasing regulation on raw material sourcing has prompted demand for suppliers with transparent quality documentation and compliance certifications.

• Geopolitical Factors: Trade policies and tariffs influence sourcing strategies, prompting diversification and local manufacturing investments.

• Quality and Certification: Growing emphasis on supply chain transparency drives procurement from suppliers with recognized quality certifications and robust quality management systems.

Emerging Opportunities

• Bio-based APIs: Development of bio-fermentation methods for pyridoxine hydrochloride is gaining interest due to sustainability and purity benefits.

• Custom Synthesis and Formulation Services: Suppliers offering integrated services from synthesis to formulation facilitate streamlined supply chains.

• Regional Manufacturing Expansion: Countries like India and China continue investing in expanding API manufacturing capacity to meet global demands, mitigating supply shortages.

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Conclusion

Securing reliable bulk sources for doxylamine succinate and pyridoxine hydrochloride requires strategic assessment of supplier quality, regulatory compliance, cost, and supply chain stability. Indian manufacturers currently lead on both APIs, supported by stringent quality standards and cost efficiency, making them preferred partners globally. Chinese suppliers offer cost advantages but must demonstrate consistent quality and regulatory compliance. Market players should prioritize suppliers with proven track records, comprehensive documentation, and capacity to meet industry standards. As global demand for these APIs persists and regulatory landscapes evolve, building diversified supplier networks remains vital for pharmaceutical companies seeking secure, high-quality sourcing.

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Key Takeaways

• Indian and Chinese manufacturers dominate the global API supply landscape for both doxylamine succinate and pyridoxine hydrochloride.

• Quality certifications such as cGMP, WHO-GMP, and detailed regulatory documentation are critical selection criteria.

• Cost-effective sourcing must be balanced with compliance to regulatory standards to avoid supply disruptions.

• Ongoing industry trends favor suppliers investing in quality assurance, transparency, and capacity expansion.

• Diversification of API sources reduces dependency risk and supports regulatory compliance across multiple markets.

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FAQs

1. What are the primary factors influencing the choice of API suppliers for doxylamine succinate and pyridoxine hydrochloride?
Quality standards, regulatory compliance, cost, supply chain reliability, and supplier reputation are critical factors influencing procurement decisions.

2. Are Indian API manufacturers compliant with international regulatory standards?
Yes. Many Indian manufacturers operate under cGMP and WHO-GMP certifications, adhering to international quality standards suitable for global markets.

3. How does regulatory compliance impact API sourcing decisions?
Regulatory compliance ensures the API’s acceptability in target markets, minimizes registration hurdles, and mitigates risks of supply rejection or recall.

4. What role do Chinese API manufacturers play in the global supply chain?
Chinese suppliers provide cost-effective APIs but may require due diligence regarding quality certifications and regulatory documentation to meet international standards.

5. What future developments could affect API sourcing strategies for these compounds?
Advancements in bio-fermentation, increased regulatory scrutiny, geopolitical shifts, and capacity expansions will influence sourcing strategies and supplier selection.

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References

1. [1] "Active Pharmaceutical Ingredients: Global Market Trends and Supply Chain Insights," Pharmaceutical Technology, 2022.
2. [2] "Global API Manufacturing and Supply Chain Dynamics," IQVIA, 2021.
3. [3] "Indian Pharmaceutical Industry Overview," Department of Pharmaceuticals, Government of India, 2022.
4. [4] "Chinese API Industry Overview," China National Pharmaceutical Industry Information Centre, 2022.
5. [5] "Regulatory Standards for APIs," U.S. Food and Drug Administration (FDA), 2023.