Suppliers and packagers for generic pharmaceutical drug: AMISULPRIDE

AMISULPRIDE

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: AMISULPRIDE

Last updated: July 28, 2025

Introduction

Amisulpride is an atypical antipsychotic medication primarily used to treat schizophrenia and other psychotic disorders. It is known for its selective dopamine D2/D3 receptor antagonism, offering therapeutic benefits with a unique side effect profile. As a prescription drug, its manufacturing, supply chain, and supplier landscape are complex, involving global pharmaceutical companies, generics manufacturers, and specialized chemical providers. Understanding the key suppliers for amisulpride is essential for pharmaceutical companies, generic manufacturers, and healthcare market analysts aiming to navigate procurement, regulatory compliance, and strategic planning.

Manufacturers of Amisulpride

The global supply of amisulpride involves both originator companies and proliferation of generic producers. The original formulation was developed by Sanofi-Aventis (now Sanofi), with the drug initially marketed under brand names such as Solian. Following patent expiration in many jurisdictions, multiple generics have entered the market.

Key Brand Name Suppliers

• Sanofi: As the originator, Sanofi retains manufacturing rights in various regions. However, in markets where patent exclusivity has expired, Sanofi typically withdraws from direct supply and licenses production to generic firms.
• Egis Pharmaceuticals: A notable European manufacturer producing amisulpride generics, including formulations suitable for hospital and retail pharmacies.
• Torrent Pharmaceuticals: An Indian pharmaceutical company manufacturing amisulpride in multiple formulations for domestic and export markets.
• Mitsubishi Tanabe Pharma: Japanese-based producer handling national supply with high-quality standards.
• Lupin Limited: Prominent Indian generics producer manufacturing amisulpride for domestic and international markets.
• Aurobindo Pharma: Another Indian manufacturer with a significant portfolio, including amisulpride.

Generic Manufacturers and Suppliers

Post-patent expiry, amisulpride's manufacturing landscape expanded notably, with generic companies becoming primary suppliers. These companies often operate in regions like India, China, Eastern Europe, and Latin America, which are major hubs for generic drug production.

• Sun Pharmaceutical Industries: Among the world's largest generic drug producers, manufacturing amisulpride for various markets.
• Dr. Reddy’s Laboratories: Indian multinational with a comprehensive portfolio, manufacturing amisulpride in multiple formulations.
• Zydus Cadila: Offers amisulpride generics in select regions, focusing on affordability.
• Hikma Pharmaceuticals: Specialized in injectables and oral formulations, including amisulpride.
• Boehringer Ingelheim: As a licensed producer of certain neuropsychiatric medications, also supplies amisulpride in select markets.

Chemical and Active Pharmaceutical Ingredient (API) Suppliers

Manufacturing high-quality amisulpride requires sourcing of advanced chemical precursors and APIs. Suppliers in this segment are crucial for maintaining consistency, regulatory compliance, and cost-efficiency.

• Yifan Pharmaceutical: Chinese supplier specializing in APIs for antipsychotics.
• Golden Triangle Chemicals: Indian API manufacturer with experience in psychotropic compounds.
• Hetero Labs: Indian API producer with a portfolio including neuroleptics.
• Zhejiang Heshi Chemical: Chinese company supplying chemical intermediates for amisulpride synthesis.

Supply Chain Dynamics and Regulatory Considerations

The supply lifecycle of amisulpride is influenced by regional patent laws, regulatory approvals, manufacturing capacities, and geopolitical factors. Countries like India and China are dominant producers due to lower production costs and increasing capacity, but regulatory audits and compliance (FDA, EMA, PMDA) are critical to ensuring supplier reliability.

Manufacturers often enter into contracts with pharmaceutical companies for bulk supply, with long-term agreements centered around maintaining quality standards like Good Manufacturing Practice (GMP). The complexity is compounded by the need for regulatory submissions, quality control, and validation processes across different markets.

Market Trends and Future Outlook

The rising prevalence of schizophrenia and psychotic disorders globally sustains demand for amisulpride. As patents expire, a proliferation of affordable generics is expected, further diversifying supplier options. Strategic companies are increasingly engaging in portfolio diversification and establishing multiple supplier relationships to mitigate supply risks and meet global demand efficiently.

Conclusion

The amisulpride supply landscape consists of a spectrum of manufacturers ranging from original developers like Sanofi to numerous Indian and Chinese generic producers, alongside specialized chemical suppliers. Critical to this supply chain is adherence to regulatory standards and quality assurance. As demand continues to grow and patent protections diminish, the supplier ecosystem will likely expand, with emerging players gaining prominence.

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Key Takeaways

• Diverse Supplier Base: Amisulpride's supply is characterized by multiple global manufacturers, with Indian and Chinese companies dominating the generic production arena.
• Regulatory Compliance: Suppliers must meet stringent GMP standards; regulatory approvals significantly influence supplier selection.
• Strategic Sourcing: Companies should diversify suppliers to mitigate risks related to geopolitics, production disruptions, and regulatory changes.
• Market Growth: Increasing global demand for amisulpride indicates sustained procurement opportunities for reliable suppliers.
• Patent Dynamics: Patent expirations have expanded the supplier landscape, fostering competitive pricing and broader access to the drug.

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FAQs

1. Which are the leading global manufacturers of amisulpride?
Major manufacturers include Sanofi (originator), Egis Pharmaceuticals, Torrent Pharmaceuticals, Lupin Limited, Aurobindo Pharma, and Sun Pharmaceutical Industries, particularly in markets where patents have expired.

2. Are there regional differences in amisulpride suppliers?
Yes. Indian and Chinese generics dominate the supply chain, especially in emerging markets, while European and Japanese firms supply more regulated markets with high-quality standards.

3. What factors influence the choice of amisulpride supplier?
Regulatory compliance, production capacity, cost efficiency, quality assurance, supply reliability, and geographic considerations are key factors.

4. How does patent expiry impact amisulpride supply?
Patent expiry facilitates entry of multiple generic manufacturers, increasing supply options, lowering costs, and expanding access, but also necessitates vigilant quality assurance.

5. What are the future trends in amisulpride supply?
Growth in demand, ongoing patent expirations, and manufacturing capacity expansion in Asia suggest a more competitive and robust supplier environment in the coming years.

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References

[1] Sanofi. Solian (amisulpride) product information.
[2] E-GMP Certified Manufacturer Profiles – European Market.
[3] Indian Drug Manufacturers API Reports.
[4] Global Pharmaceutical Market Analysis 2022.
[5] Regulatory Guidelines for Pharmaceutical APIs – FDA, EMA compliance standards.