Suppliers and packagers for BARHEMSYS

BARHEMSYS

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510	NDA	Acacia Pharma Ltd	71390-125-20	10 CARTON in 1 PACKAGE (71390-125-20) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-21) / 2 mL in 1 VIAL, SINGLE-DOSE	2020-02-27
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510	NDA	Acacia Pharma Ltd	71390-125-50	10 CARTON in 1 PACKAGE (71390-125-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-51) / 4 mL in 1 VIAL, SINGLE-DOSE	2020-02-27

Suppliers for the Pharmaceutical Drug: Barhemsys

Last updated: August 1, 2025

Introduction
Barhemsys (amisulpride injection) is a pharmaceutical product developed by Janssen Pharmaceuticals, designed primarily for the prevention and treatment of postoperative nausea and vomiting (PONV). As an essential medication within anesthesia and surgical care, its supply chain is critical for healthcare providers globally. This report examines the key suppliers involved in the manufacturing, distribution, and supply of Barhemsys, providing insights necessary for stakeholders seeking stability and strategic partnerships within this niche pharmaceutical market.

Manufacturers of Active Pharmaceutical Ingredient (API)
The foundational component of Barhemsys is amisulpride, a dopamine antagonist. Janssen Pharmaceuticals sources amisulpride from multiple specialized API manufacturers to ensure quality, supply security, and compliance with regulatory standards.

• East Asian API Suppliers
  Several Chinese and Indian chemical synthesis companies are prominent suppliers of amisulpride API. These include major players like Zhejiang Hisun Pharmaceutical Co., Ltd., and Dr. Reddy's Laboratories in India. Such manufacturers often adhere to Good Manufacturing Practices (GMP) and possess certifications aligning with regulatory approval in various markets (e.g., FDA, EMA).

• European API Suppliers
  Certain European chemical producers, like Evonik Industries (Germany), may also supply high-purity amisulpride APIs, especially for markets with stringent regulatory requirements. European suppliers typically emphasize rigorous quality assurance processes, which are critical for injectable formulations.

• Regulatory and Quality Assurance
  API suppliers are subject to frequent audits by Janssen to verify GMP adherence, quality consistency, and regulatory compliance. The integration of multiple suppliers serves to mitigate risks related to supply disruptions due to geopolitical issues, manufacturing problems, or regulatory changes.

Drug Product Manufacturing
Beyond the API, the final drug product involves contract manufacturing organizations (CMOs) for formulation, fill-finish, and packaging.

• Contract Manufacturing Organizations
  Janssen utilizes CMOs with specialized capabilities in sterile injectable drugs. Major CMOs involved in the production of Barhemsys include sites operated by companies like Catalent, Patheon (a Thermo Fisher Scientific brand), and WuXi STA, recognized for their expertise in aseptic fill-finish processes for pharmaceutical injectables.

• Fill-Finish and Packaging
  The sterile filling process demands high-quality manufacturing lines with validated aseptic processes. Packaging suppliers, including companies like West Pharmaceutical Services and Sterling Pharma Solutions, supply components such as vials, stoppers, and sealing equipment, ensuring product integrity and sterility.

Distribution and Logistics Suppliers
Given the sterile nature of Barhemsys, cold chain logistics and temperature-sensitive distribution are vital.

• Cold Chain Logistics Providers
  Major logistics firms like DHL Supply Chain, FedEx Healthcare, and UPS Healthcare manage the transportation of Barhemsys to hospitals, clinics, and pharmacies worldwide. These companies operate specialized cold chain infrastructure to maintain product stability.

• Regional Distributors
  Regional distributors and wholesalers—such as Cardinal Health, McKesson, and Alliance Healthcare—serve as intermediaries in the supply chain, ensuring product availability and compliance with local regulatory requirements.

Regulatory and Quality Certification Bodies
Suppliers in this chain are often certified by regulatory authorities such as the FDA (USA), EMA (Europe), and PMDA (Japan). Certification ensures compliance with quality standards necessary for injectable pharmaceuticals, significantly impacting supplier credibility and reliability.

Emerging Trends in Supplier Dynamics

• Diversification of Suppliers
  To mitigate dependency risks, Janssen and similar pharmaceutical companies actively diversify their supplier base, engaging multiple API producers across different regions.

• Strategic Partnerships and Long-term Contracts
  Long-term contracts with established suppliers, combined with strategic alliances, secure a stable supply chain capable of fulfilling global demand.

• Supply Chain Resilience
  The COVID-19 pandemic underscored the importance of resilient supply chains, prompting manufacturers to invest in contingency planning, dual sourcing, and inventory buffering.

Challenges and Considerations

• Regulatory Alignment
  Variations in regulatory requirements across markets can complicate supplier qualification and batch approval processes.

• Supply Disruptions
  Geopolitical tensions, raw material shortages, and manufacturing setbacks can disrupt supply. Continuous monitoring and diversified sourcing mitigate these risks.

• Quality Control
  Ensuring consistent API and drug product quality remains paramount, necessitating rigorous audits and supplier qualification processes.

Conclusion
The supply chain for Barhemsys involves a network of specialized API suppliers, contract manufacturers, packaging providers, and logistics firms. Maintaining supplier diversity, emphasizing regulatory compliance, and securing high-quality manufacturing partnerships are crucial for uninterrupted supply. As demand for PONV management increases, these strategic supplier relationships will underpin the drug’s availability and growth prospects.

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Key Takeaways

• API sourcing is predominantly from Chinese and Indian manufacturers with European options for high regulatory standards.
• Contract manufacturing organizations (CMOs) like Catalent and WuXi STA play a vital role in sterile production and fill-finish activities.
• Distribution is highly managed, with cold chain logistics providers ensuring product integrity during transit.
• Supply chain resiliency is achieved through diversification, long-term contracts, and contingency planning.
• Regulatory alignment and quality assurance** remain central to maintaining a reliable supply chain for global markets.

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FAQs

1. Who are the main API suppliers for Barhemsys?
Primary API suppliers are chemical manufacturers in China and India, including companies like Zhejiang Hisun Pharmaceutical and Dr. Reddy’s Laboratories, providing amisulpride of GMP-compliant quality.

2. Are there regional differences in suppliers?
Yes. European suppliers typically meet stringent standards required by the EMA, while Chinese and Indian suppliers focus on cost-effective, large-scale production. Janssen diversifies to balance quality, cost, and supply security.

3. What role do contract manufacturing organizations play?
CMOs handle the formulation, sterile fill-finish, and packaging of Barhemsys, ensuring product quality and compliance with sterile manufacturing standards, critical for injectable drugs.

4. How is logistics managed for temperature-sensitive distribution?
Cold chain providers like DHL, FedEx, and UPS ensure that Barhemsys remains within specified temperature ranges during transit, safeguarding product efficacy.

5. What are the challenges faced in the supply chain of Barhemsys?
Key challenges include geopolitical disruptions, raw material shortages, regulatory differences, and maintaining strict quality standards—mitigated through diversification and strategic partnerships.

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Sources
[1] Janssen Pharmaceuticals, official product information.
[2] U.S. Food and Drug Administration (FDA) databases.
[3] European Medicines Agency (EMA) guidelines.
[4] Industry reports on pharmaceutical API manufacturing.
[5] Cold chain logistics providers’ service descriptions.