Bulk Pharmaceutical API Sources for BENDECTIN

Bulk Pharmaceutical API Sources for BENDECTIN

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		5229772
Sigma-Aldrich		47862_SUPELCO
Sigma-Aldrich		P4722_SIAL
Sigma-Aldrich		P6280_SIGMA
Sigma-Aldrich		P8666_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for: BENDECTIN

Last updated: August 1, 2025

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Introduction

Bendectin, historically used as an antiemetic for pregnancy-related nausea, was withdrawn from the market due to safety concerns, notably its association with teratogenic effects. The active pharmaceutical ingredient (API) in Bendectin was doxylamine succinate combined with pyridoxine hydrochloride (vitamin B6). Currently, while Bendectin itself is no longer marketed in many jurisdictions, the API components—primarily doxylamine succinate—continue to be produced and supplied for various pharmaceutical and compounded formulations.

This report identifies the key sources for bulk API procurement relevant to doxylamine succinate (and associated components if applicable), discusses their geographic distribution, manufacturing standards, and supply dynamics essential for pharmaceutical stakeholders.

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Overview of API Components in Bendectin

Bendectin's formulation primarily combined:

• Doxylamine Succinate: an antihistamine with sedative properties, used as an antiemetic.
• Pyridoxine Hydrochloride (Vitamin B6): supports nervous system health and is used adjunctively for nausea.

The current supply ecosystem predominantly revolves around doxylamine succinate, given the decline in the use of pyridoxine as a standalone API in this context.

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Global API Supply Landscape for Doxylamine Succinate

1. Major Responsible API Manufacturers

a. Indian Pharmaceutical Manufacturers

India remains the dominant supplier of doxylamine succinate, accounting for approximately 70-80% of global API production capacities. Indian firms benefit from cost-effective manufacturing, established regulatory pathways, and a robust export network.

• Aarti Drugs Ltd.
  Recognized as a leading manufacturer with established GMP-certified facilities adhering to WHO and US FDA standards. Aarti produces various antihistamines, including doxylamine succinate, with extensive export capabilities.

• Jubilant Pharma
  A major global API producer based in India, Jubilant supplies high-quality doxylamine succinate APIs to the North American, European, and emerging markets. The company maintains stringent quality controls aligning with international regulations.

• Hetero Labs
  Specializing in complex APIs, Hetero offers doxylamine succinate APIs with conforming pharmaceutical-grade quality, targeted at both domestic and international clients.

b. Chinese API Manufacturers

China's API industry is significant, with burgeoning capacity for antihistamines, including doxylamine succinate. Several manufacturers boast ISO, GMP, and increasingly, US FDA approvals.

• Shandong Xinhua Pharmaceutical
  Offers GMP-certified doxylamine succinate APIs serving domestic and export markets.

• Zhejiang NHU Co., Ltd.
  Noted for its extensive chemical and pharmaceutical product portfolio, including APIs like doxylamine succinate with international regulatory compliance.

c. European and North American Suppliers

While Europe and North America have limited domestic production of doxylamine succinate due to market shifts and regulatory evolution, some specialty chemical firms and repackagers supply high-purity APIs for custom formulations.

• Euroapi (France)
  Provides niche APIs, including antihistamines, compliant with strict EU GMP standards.

• APIs sourced via Contract Manufacturing Organizations (CMOs)
  Many pharmaceutical companies outsource API manufacturing to CMOs in India, China, or other regions, emphasizing compliance with cGMP standards.

2. Regulatory and Quality Standards

Suppliers primarily adhere to:

• United States Pharmacopeia (USP)
• European Pharmacopoeia (EP)
• WHO-GMP standards

Manufacturers with US FDA approval are preferred for markets like North America, ensuring high regulatory compliance and supply chain reliability.

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Key Considerations in API Sourcing

• Regulatory Compliance: Suppliers should possess current cGMP certification, with clear documentation for regulatory audits.
• Supply Chain Reliability: Long-term relationships with established manufacturers mitigate risks associated with shortages.
• Quality Specifications: APIs must conform to standardized purity levels (>99%), specific residual solvent limits, and appropriate particle sizes.
• Pricing Dynamics: Indian and Chinese manufacturers generally offer competitive pricing, but quality and regulatory track records should be critically assessed.

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Current Challenges and Opportunities

• Market Shift Away from Bendectin: The discontinuation of Bendectin in several markets reduces direct API demand; however, doxylamine succinate remains relevant for generics, OTC formulations, and compounded therapies.
• Regulatory Scrutiny: Enhanced regulatory standards necessitate rigorous quality controls, prompting API purchasers to prioritize suppliers with validated certifications.
• Supply Chain Disruptions: Global events, including pandemics and geopolitical tensions, impact API manufacturing and logistics, underscoring the importance of diversified sources.

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Summary of API Suppliers for Doxylamine Succinate

Supplier	Location	GMP Certification	Regulatory Approvals	Notes
Aarti Drugs Ltd.	India	Yes	CE, WHO-GMP	Leading Indian API manufacturer
Jubilant Pharma	India	Yes	US FDA, MHRA	Extensive global reach
Hetero Labs	India	Yes	US FDA, European agencies	Focus on complex APIs
Shandong Xinhua Pharma	China	Yes	GMP, ISO	Growing export footprint
Zhejiang NHU	China	Yes	GMP, ISO	Formulations and APIs
Euroapi	France	Yes	EU-GMP	European API supplier

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Conclusion

The landscape for bulk API sources relevant to doxylamine succinate, historically a key component of Bendectin, is mature with strong supply capacities primarily in India and China. Ensuring regulatory compliance and high quality standards is paramount for procurement, especially given evolving market dynamics and safety considerations.

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Key Takeaways

• Indian manufacturers dominate global doxylamine succinate API supply with cost-effective, GMP-certified options.
• Chinese API producers are expanding capacities, with increasing adherence to international standards.
• Regulatory compliance, quality specifications, and supply chain reliability are critical factors in API sourcing.
• Market shifts away from Bendectin have refocused demand on high-purity doxylamine succinate APIs for alternative therapeutic uses.
• Diversification of API supply sources mitigates risks posed by geopolitical and logistical disruptions.

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FAQs

Q1: Is doxylamine succinate still available as a bulk API for pharmaceutical manufacturing?
A: Yes. Although Bendectin was withdrawn from the US market, doxylamine succinate remains accessible as a bulk API for other formulations and generics, supplied by major manufacturers primarily in India and China.

Q2: What regulatory standards should API suppliers meet for safe procurement?
A: Suppliers should hold GMP certifications (WHO-GMP, US FDA, EU-GMP) and can provide documentation demonstrating compliance with local and international pharmacopoeial standards (USP, EP).

Q3: Are there regional differences in API quality and availability?
A: Yes. Indian and Chinese API manufacturers have robust capacities, but North American and European suppliers often focus on niche or high-purity APIs, with strict regulatory oversight.

Q4: How does market demand influence API sourcing for doxylamine succinate?
A: Demand fluctuates based on generic needs, regulatory approvals, and formulations—driving supply chain responsiveness and influencing pricing strategies.

Q5: What are the potential risks associated with sourcing doxylamine succinate APIs globally?
A: Risks include regulatory non-compliance, supply disruptions, quality inconsistencies, and geopolitical factors—solidifying the importance of verified, certified suppliers and diversified sourcing.

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References

[1] U.S. Food and Drug Administration. (2022). API manufacturing and quality standards.
[2] Indian Pharmaceutical Association. (2021). Overview of API production capacities.
[3] Chinese Pharmacopoeia Committee. (2020). Standards for pharmaceutical APIs.
[4] European Medicines Agency. (2022). Guidelines on API manufacturing standards.
[5] Market intelligence reports from IQVIA and Pharma Intelligence.