Bulk Pharmaceutical API Sources for DICLEGIS

Bulk Pharmaceutical API Sources for DICLEGIS

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

Bulk Active Pharmaceutical Ingredient (API) Sources for Diclegis

Last updated: July 31, 2025

Introduction

Diclegis®, marketed by Moda Pharmaceuticals, is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for relief of nausea and vomiting during pregnancy. Its active ingredients—doxylamine succinate and pyridoxine hydrochloride—are critical components in the formulation. The value and supply chain security of these APIs are vital for manufacturers, healthcare providers, and stakeholders committed to consistent drug availability and regulatory compliance. This analysis explores the primary sources for the bulk APIs of Diclegis, emphasizing manufacturing origination, global suppliers, quality standards, and market dynamics.

Active Pharmaceutical Ingredients in Diclegis

Diclegis comprises two active ingredients:

• Doxylamine Succinate: An antihistamine with sedative properties, traditionally used as an allergy and sleep aid.

• Pyridoxine Hydrochloride: A form of vitamin B6, essential for amino acid metabolism and neurotransmitter synthesis.

The combination provides antiemetic effects specifically tailored for pregnant patients, requiring high purity levels and stringent quality controls.

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Global API Manufacturing Landscape for Diclegis Components

Doxylamine Succinate API Sources

Historically, doxylamine succinate APIs are synthesized primarily in Asia, particularly by manufacturers based in India and China, due to cost efficiencies and established chemical manufacturing infrastructure. Companies in India, such as Hetero Drugs Ltd., Aurobindo Pharma, and Sun Pharma, are key players producing doxylamine intermediates and APIs meeting international standards.

Some of these manufacturers have obtained certifications from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory bodies, which are critical for ensuring compliance with Good Manufacturing Practices (GMP). For example:

• Hetero Drugs Ltd. supplies bulk doxylamine succinate APIs globally, including to pharmaceutical companies seeking U.S. and European approvals.

• Aurobindo Pharma maintains a dedicated API manufacturing division with strong compliance records, exporting to the U.S. and Europe due to its GMP-certified plants.

Pyridoxine Hydrochloride API Sources

Pyridoxine hydrochloride’s API is more widely produced owing to its status as a common vitamin supplement. Leading API suppliers include:

• BASF (Germany): Produces pharmaceutical-grade pyridoxine hydrochloride with high purity suitable for prescription drugs.

• Zhejiang Medicine Co., Ltd. (China): A major provider of bulk pyridoxine hydrochloride with extensive export experience and compliance with GMP standards.

• Meyer Organics (India): Supplies pharmaceutical-grade pyridoxine hydrochloride globally, with ongoing certifications to meet international health regulations.

Key Considerations for API Sourcing

• Regulatory Certification: Sourcing from GMP-compliant, FDA-registered facilities reduces compliance risks. Certified APIs facilitate easier FDA approval and batch consistency.

• Supply Chain Security: Diversified supplier portfolios mitigate risks of shortages. Given geopolitical influences, increased attention to regional manufacturing capacities is recommended.

• Quality Assurance: Suppliers providing Certificates of Analysis (CoA), stability data, and third-party testing enhance confidence in API purity and batch-to-batch consistency.

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Market Dynamics and Trends

Regional Shifts and Regulations

The API sourcing landscape is influenced by regulatory pressures, trade policies, and capacity expansions. Manufacturing hubs in India and China dominate due to established infrastructure and cost advantages, but increased scrutiny over regulatory compliance has encouraged some companies to seek European or North American API sources.

Vertical Integration and Outsourcing Strategies

Major pharmaceutical companies often adopt vertical integration models, owning API manufacturing facilities aligned with their formulations, offering greater control over quality and supply. Conversely, contract manufacturing organizations (CMOs) provide flexible sourcing options, accelerating time-to-market and reducing capital expenditures.

Supply Chain Disruptions Post-Pandemic

The COVID-19 pandemic underscored vulnerabilities in global API supply chains, prompting companies to revisit sourcing strategies. Stockpiling and regional API manufacturing are now prioritized to ensure uninterrupted supply for medications like Diclegis.

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Regulatory and Quality Assurance

Manufacturers supplying APIs for Diclegis must conform to stringent regulatory standards:

• GMP Compliance: Ensured through certifications from agencies such as the FDA, EMA, or WHO.

• Product Traceability: Complete documentation, including batch records, CoA, and stability data, is mandatory.

• Impurity Profiles: APIs must have impurity levels within pharmacopeial limits, necessitating rigorous testing regimes.

• Environmental and Ethical Standards: Suppliers committed to sustainable practices and ethical sourcing are increasingly favored amid regulatory and societal pressures.

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Key Players in APIs for Diclegis

Supplier	Region	API(s)	Certifications	Notes
Hetero Drugs Ltd.	India	Doxylamine succinate	GMP, USFDA	Major Asian supplier, compliance-focused
Aurobindo Pharma	India	Doxylamine succinate	GMP, USFDA	Wide portfolio of APIs
Zhejiang Medicine	China	Pyridoxine hydrochloride	GMP, China GMP	Leading vitamin API producer
BASF	Germany	Pyridoxine hydrochloride	GMP, EU	High purity, reliable supplier
Meyer Organics	India	Pyridoxine hydrochloride	GMP	Growing export footprint

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Emerging Trends and Outlook

The API supply chain for Diclegis is poised for evolution driven by regulatory tightening, supply chain resilience demands, and technological advances. Notable trends include:

• Shift Towards Regional API Manufacturing: To reduce lead times and mitigate geopolitical risks, some companies cultivate domestic or regional API production capacity.

• Increased Due Diligence and Supplier Vetting: Enhanced qualification processes are now standard, emphasizing compliance, quality data, and ethical manufacturing.

• Adoption of Continuous Manufacturing: Modern production methods improve efficiency, quality, and scalability for APIs.

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Conclusion

The bulk APIs for Diclegis—doxylamine succinate and pyridoxine hydrochloride—are predominantly sourced from a global network of GMP-compliant manufacturers in India, China, and Europe. Ensuring reliable, high-quality supply hinges on strategic relationships with certified suppliers capable of meeting regulatory requirements and producing APIs with consistent purity. In a landscape affected by regulatory scrutiny and supply chain complexities, diversifying sourcing and emphasizing quality assurance are indispensable for sustained market success.

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Key Takeaways

• The primary API sources for Diclegis are India, China, and Europe, with leading players including Hetero Drugs, Aurobindo Pharma, Zhejiang Medicine, and BASF.

• Ensuring API quality and regulatory compliance through certifications like GMP and USFDA approval is critical for market stability.

• The global supply chain faces ongoing pressures from geopolitical, regulatory, and pandemic-related factors, emphasizing diversification and regional manufacturing.

• Advances in manufacturing technology and stringent supplier vetting improve supply chain resilience and product quality for APIs.

• Strategic partnerships with certified API manufacturers underpin regulatory approval, product consistency, and commercial success.

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Frequently Asked Questions (FAQs)

1. Where are the most reliable API manufacturers for Diclegis components located?
   The most reliable sources are GMP-certified manufacturers in India (Aurobindo, Meyer Organics), China (Zhejiang Medicine), and Europe (BASF). These regions have established regulations and quality standards aligned with international requirements.

2. What should buyers consider when sourcing APIs for Diclegis?
   Buyers should evaluate supplier certifications, track record, impurity profiles, manufacturing capacity, and compliance with GMP and FDA standards to ensure quality and regulatory adherence.

3. Are there emerging regional API manufacturing hubs for Diclegis?
   Yes, including North America and Europe, as companies seek to diversify supply chains and mitigate geopolitical and logistics risks, with some API production shifting closer to end markets.

4. How do regulatory standards impact API sourcing for Diclegis?
   Strict adherence to GMP and certification requirements (e.g., FDA, EMA) ensures APIs meet purity, potency, and safety standards, facilitating faster approval and reducing compliance risks.

5. What trends are shaping the future of API sourcing for pharmaceuticals like Diclegis?
   Trends include increased regional manufacturing, adoption of continuous and advanced manufacturing technologies, and greater emphasis on supply chain resilience and sustainability.

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Sources:

1. U.S. Food and Drug Administration (FDA). [Code of Federal Regulations - Good Manufacturing Practices].
2. IQVIA Institute. (2022). "Global API Supply Chains Post-Pandemic."
3. Pharma Manufacturing. (2023). "Top API Manufacturers and Regulations."
4. MarketWatch. (2023). "API Market Dynamics and Trends."
5. European Medicines Agency (EMA). "API Certification and Standards."