Suppliers and packagers for bonjesta

bonjesta

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661	NDA	Duchesnay USA, Inc.	55494-120-10	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10)	2018-02-19
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661	NDA	Duchesnay USA, Inc.	55494-120-60	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60)	2018-02-19
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661	NDA	Duchesnay USA, Inc.	55494-120-94	1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2018-02-19
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661	NDA	Duchesnay USA, Inc.	55494-120-99	6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99)	2018-02-19

Suppliers for the Pharmaceutical Drug: Bonjesta

Last updated: July 31, 2025

Introduction

Bonjesta is a prescription medication used to treat nausea and vomiting associated with pregnancy, marketed under the generic name doxylamine succinate and pyridoxine hydrochloride. It is a combination of antihistamine and vitamin B6, designed to provide relief for pregnant women experiencing moderate to severe morning sickness. Understanding the suppliers of Bonjesta involves examining its manufacturing process, regulatory approvals, and the pharmaceutical companies responsible for its production and distribution. This article provides a comprehensive overview of the key suppliers involved in the Bonjesta supply chain, emphasizing their roles, market dynamics, and implications for stakeholders.

Overview of Bonjesta Production

Bonjesta is manufactured primarily by Duchesnay Inc., a Canadian pharmaceutical company specializing in women’s health. Originally marketed as Diclegis in the United States, the drug's formulation was subsequently branded as Bonjesta to reflect its prolonged-release profile and targeted therapeutic application. The active ingredients—doxylamine succinate and pyridoxine hydrochloride—are standard compounds with well-established manufacturing processes, but their combination as Bonjesta involves a specific formulation process that must adhere to stringent regulatory standards.

Major Suppliers of Active Pharmaceutical Ingredients (APIs)

The production of Bonjesta hinges critically on the availability of high-quality active pharmaceutical ingredients (APIs): doxylamine succinate and pyridoxine hydrochloride. These APIs serve as the foundation for the medication and require reliable sourcing from specialized suppliers.

• Doxylamine Succinate Suppliers

Doxylamine succinate is a first-generation antihistamine with sedative properties. Multiple global suppliers manufacture this API, primarily located in China and India, which dominate the global API market due to established manufacturing capabilities and cost advantages. These suppliers produce pharmaceutical-grade doxylamine succinate conforming to standards such as the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP). Notable suppliers include Zhejiang Hisun Pharmaceutical Co., Ltd., Alpheus Pharmaceuticals Ltd., and other contract manufacturing organizations (CMOs) with Approved Good Manufacturing Practices (GMP) certifications.

• Pyridoxine Hydrochloride Suppliers

Vitamin B6 (pyridoxine hydrochloride) is widely produced globally, frequently in India, China, and Europe. Suppliers such as Cadila Healthcare, Merck, and several contract manufacturers supply high-purity pyridoxine suitable for pharmaceutical formulations. The widespread availability ensures a stable supply chain, but quality assurance remains critical due to the essential role of these ingredients and strict regulatory standards.

Contract Manufacturing Organizations (CMOs)

Given the complexity of formulation and strict regulatory oversight, Duchesnay relies on several CMOs for the manufacturing of Bonjesta’s dosage forms. These organizations are responsible for the formulation, encapsulation, and packaging of the final product, ensuring compliance with FDA and international standards. Notable CMOs involved in the production include:

• Catalent Pharma Solutions: Known for advanced formulation and manufacturing capabilities.
• Patheon (a part of Thermo Fisher Scientific): Offers extensive pharmaceutical manufacturing services, including extended-release formulations.
• SGS Life Sciences: Provides quality assurance, analytical testing, and validation services.

These organizations source APIs either directly from primary API manufacturers or through authorized distributors, emphasizing the importance of a well-managed procurement process to ensure product integrity.

Regional Distribution and Supply Chain Dynamics

The supply of Bonjesta depends on a complex, multi-tiered supply chain that includes raw material procurement, manufacturing, packaging, and distribution. The primary manufacturing locations for APIs and formulated products are often in North America, Europe, and Asia. The COVID-19 pandemic accentuated vulnerabilities in this interconnected supply chain, leading to increased emphasis on supply chain resilience and diversification.

Furthermore, there is a significant reliance on suppliers in China and India for API procurement, which presents both advantages (cost efficiency) and risks (regulatory, geopolitical). Duchesnay and other stakeholders actively engage in supply chain monitoring and contingency planning to mitigate shortages or disruptions.

Regulatory Considerations

The US Food and Drug Administration (FDA) and other global regulatory agencies closely oversee the manufacturing processes for Bonjesta, requiring suppliers to adhere to GMP regulations. Suppliers must also undergo rigorous audits and provide detailed documentation to meet pharmacopoeia standards, ensuring the APIs are of consistent quality.

Duchesnay, like other pharmaceutical companies, manages its supplier relationships through supplier qualification programs, validation protocols, and ongoing quality assessments. These steps are vital to maintaining the manufacturing integrity and safety of Bonjesta.

Market and Competitive Landscape

While Duchesnay is the primary supplier and marketer of Bonjesta, competition exists within the broader category of antiemetics used in pregnancy, such as doxylamine combinations with other vitamins or alternative therapies. The drug’s exclusivity and patent status influence supplier negotiations and supply chain complexity. Additionally, regulatory exclusivities prevent generic versions from entering the market immediately, but at expiration, multiple suppliers might emerge.

Emerging Trends and Future Outlook

The growing focus on supply chain transparency and sustainability impacts Bonjesta’s supplier landscape. Companies are increasingly engaging in responsible sourcing practices, diversifying API suppliers, and investing in alternative manufacturing sites to reduce dependency on specific regions.

Furthermore, advancements in manufacturing technology, such as continuous manufacturing and improved API synthesis pathways, could alter supplier dynamics, potentially leading to cost reductions or enhanced product quality.

Conclusion

The supply of Bonjesta involves a carefully coordinated network of API suppliers, contract manufacturers, and quality assurance providers. While Duchesnay remains the primary responsible entity, the foundational ingredients—doxylamine succinate and pyridoxine hydrochloride—are sourced from major global suppliers, predominantly in Asia. The stability and security of this supply chain are crucial for ensuring continuous availability, regulatory compliance, and patient safety. As the market evolves, diversification strategies and technological innovations will play vital roles in shaping the future supplier landscape for Bonjesta.

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Key Takeaways

• Primary API Suppliers: Doxylamine succinate and pyridoxine hydrochloride are globally sourced from specialized producers in China and India, emphasizing the importance of robust supplier qualification and quality standards.
• Manufacturing Partners: Major CMOs such as Catalent and Patheon facilitate formulation and final product assembly, adhering to strict GMP guidelines.
• Supply Chain Risks: Dependence on API suppliers from specific regions introduces vulnerabilities that companies are mitigating through diversification and contingency planning.
• Regulatory Oversight: Compliance with FDA and international standards is paramount, impacting supplier selection, validation, and ongoing monitoring.
• Market Dynamics: Patent protections and exclusivity influence supplier relationships and the entry of generics post-expiry, affecting market competition and supply security.

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FAQs

1. Who are the main suppliers of the active ingredients for Bonjesta?
The primary suppliers of doxylamine succinate and pyridoxine hydrochloride are large pharmaceutical manufacturing companies based in China and India, such as Zhejiang Hisun Pharmaceutical Co., Ltd. and Cadila Healthcare.

2. How does Duchesnay ensure product quality from its suppliers?
Duchesnay employs rigorous supplier qualification programs, conducts GMP audits, and enforces strict quality agreements to guarantee the consistency and safety of the APIs used in Bonjesta.

3. Are there alternative sources for Bonjesta’s ingredients?
Yes, multiple suppliers produce these APIs, and companies can source from different regions to mitigate risks. However, switching suppliers requires extensive validation to meet regulatory standards.

4. What role do contract manufacturing organizations play in Bonjesta’s supply chain?
CMOs handle formulation, encapsulation, and packaging processes, ensuring the final product complies with quality standards and regulatory requirements.

5. What future trends could impact the supply of Bonjesta?
Technological advancements in manufacturing, geopolitical factors affecting API sourcing, and increasing emphasis on supply chain resilience are shaping the future landscape for Bonjesta’s global supply chain.

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References:

[1] FDA Approval Letter for Diclegis (now Bonjesta) and related regulatory documentation.
[2] Global API Market Reports, 2022.
[3] Duchesnay Inc. official website and product literature.
[4] WHO Essential Medicines List and manufacturing guidelines.
[5] Industry analyses on supply chain resilience in pharmaceuticals.