Bulk Pharmaceutical API Sources for LURASIDONE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for LURASIDONE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS022185856
Molport		MolPort-035-395-724
TargetMol		T1735
ChemShuttle		151800
Sigma-Aldrich		L-030_CERILLIAN
LGC Standards		MM3647.00

Bulk Active Pharmaceutical Ingredient (API) Sources for: Lurasidone Hydrochloride

Last updated: July 28, 2025

Introduction

Lurasidone hydrochloride is a second-generation atypical antipsychotic primarily prescribed for schizophrenia and bipolar disorder. As the pharmaceutical industry emphasizes quality, supply chain reliability, and regulatory compliance, identifying reputable sources of bulk Lurasidone hydrochloride is crucial for manufacturers, wholesalers, and regulatory authorities. This report consolidates global API suppliers specializing in Lurasidone hydrochloride, analyzing their manufacturing capabilities, regulatory compliance, and strategic positioning within the pharmaceutical supply chain.

Manufacturing Landscape and Key API Suppliers

Global Market Overview

Lurasidone hydrochloride’s complex synthesis demands rigorous quality control, compliance with Good Manufacturing Practices (GMP), and proven supply stability. The active pharmaceutical ingredient (API) is produced mainly by a handful of advanced pharmaceutical manufacturers across Asia, Europe, and North America. The burgeoning demand for atypical antipsychotics, coupled with patent expiration strategies, has heightened competition among API suppliers.

Major API Suppliers for Lurasidone Hydrochloride

1. Hangzhou Huahai Pharmaceutical Co., Ltd. (China)

   A prominent Chinese manufacturer, Huahai is known for producing high-quality generic APIs, including Lurasidone hydrochloride. The company boasts extensive GMP certification and adheres to stringent quality standards aligned with international regulators. Their scale-up capabilities allow for consistent supply to meet global demand.

2. Jubilant Life Sciences (India)

   Jubilant is recognized for its robust API R&D and manufacturing infrastructure. Their facilities are GMP-certified, and they have a track record of supplying generic APIs across global markets. Jubilant’s expertise in complex synthesis processes positions them as a reliable source for Lurasidone hydrochloride.

3. Zhejiang Hailong Pharmaceutical Co., Ltd. (China)

   Specializing in psychiatric APIs, Zhejiang Hailong offers bulk Lurasidone hydrochloride with competitive pricing and certification aligned with ICH Q7 guidelines. Their strategic location in Zhejiang enables expedited shipping to major markets in Asia, Europe, and North America.

4. Mitsubishi Tanabe Pharma Corporation (Japan)

   As an originator and producer of Lurasidone (brand name Latuda), Mitsubishi Tanabe maintains a strict control over their active ingredient manufacturing process, ensuring high purity and consistency. While primarily a proprietary supplier, their APIs are often available for licensing or custom manufacturing arrangements.

5. Sino Biopharmaceutical Limited (Hong Kong/China)

   They focus on high-quality generic APIs with domestic and international certifications. Their facilities are compliant with global regulatory standards, and they have recently expanded capacity for complex APIs like Lurasidone hydrochloride.

Emerging Suppliers and Contract Manufacturing Organizations (CMOs)

• Dr. Reddy’s Laboratories (India): Increasingly involved in complex antipsychotic APIs, with GMP-certified facilities capable of scale-up.

• CordenPharma (Europe): Specializes in custom synthesis and supply of highly potent APIs, including complex compounds analogous to Lurasidone.

• BASF (Germany): Typically focuses on intermediates, but some segments develop APIs, emphasizing high purity requirements for psychotropic medications.

Regulatory Standards and Quality Assurance

Suppliers operating globally must demonstrate compliance with various regulatory standards:

• GMP Certification: Ensures consistent quality, purity, and potency.
• ICH Guidelines (Q7, Q11): Management of active ingredient manufacturing processes.
• USP and EP Certifications: Ensuring API quality aligns with pharmacopoeia standards where applicable.
• Inspection Histories: Proven track record of successful audits from agencies such as the FDA, EMA, or MHRA further validate supplier reliability.

Only suppliers with recognized certifications and transparent quality assurance protocols should be considered for sourcing Lurasidone hydrochloride.

Supply Chain Considerations

• Capacity and Reliability: Manufacturers with diversified production sites mitigate supply risks.
• Pricing and Lead Times: Competitive pricing often correlates with manufacturing scale; however, quality must never be compromised.
• Intellectual Property and Licensing: Some suppliers may offer APIs under licensing agreements, affecting procurement strategies.
• Geopolitical Factors: Trade policies, tariffs, and export restrictions can influence sourcing decisions.

Trends in API Sourcing for Lurasidone Hydrochloride

• Increased Reliance on Chinese and Indian Manufacturers: Due to cost advantages and expanding manufacturing capacities.
• Focus on Quality and Regulatory Compliance: Suppliers with proven track records are favored amid stricter global regulatory scrutiny.
• Dual Sourcing Strategies: Combining API sources from multiple vendors reduces risks associated with supply disruptions and quality issues.
• Development of Regional Manufacturing Hubs: To meet regional regulatory requirements and accelerate supply timelines.

Conclusion

The procurement of bulk Lurasidone hydrochloride requires a comprehensive assessment of supplier capabilities, regulatory compliance, and supply chain resilience. Leading manufacturers in China, India, Japan, and Europe dominate the market, each with unique strengths. Strategic partnerships with verified, GMP-compliant suppliers enable pharmaceutical companies to secure consistent high-quality API supply, essential for manufacturing safe and effective generic and branded medications.

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Key Takeaways

• Supplier Due Diligence is Paramount: Only engage with suppliers holding recognized GMP certifications and a clean regulatory track record.
• Diversify Supply Sources: Reduce risk by establishing relationships with multiple qualified API manufacturers.
• Prioritize Regulatory Compliance: Ensure APIs meet pharmacopoeia standards (USP, EP) and adhere to ICH guidelines.
• Assess Capacity and Reliability: Favor suppliers with scalable production capacities and proven supply chain reliability.
• Monitor Industry Trends: Stay informed about geopolitical developments, new manufacturing entrants, and technological advances influencing API sourcing.

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FAQs

1. What are the most trusted API suppliers for Lurasidone hydrochloride?
   Leading suppliers include Hangzhou Huahai Pharmaceutical (China), Jubilant Life Sciences (India), and Mitsubishi Tanabe Pharma (Japan), all known for GMP compliance and quality assurance.

2. How does regulatory compliance influence API sourcing decisions?
   Regulatory compliance ensures API safety, efficacy, and quality, compliant products reduce the risk of regulatory denial and product recalls.

3. Can generic API suppliers match the quality of originator APIs?
   Yes, many advanced generic manufacturers produce APIs that meet or exceed originator standards; certification and audit history are critical indicators.

4. What are the risks associated with sourcing APIs from emerging markets?
   Potential risks include variability in quality standards, regulatory recognition, and supply chain disruptions. Choosing suppliers with proven compliance mitigates these risks.

5. How does geopolitics impact API supply chains?
   Trade restrictions, tariffs, and geopolitical tensions can affect availability and pricing. Diversification and regional sourcing strategies are recommended to mitigate these risks.

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References

[1] GlobalData, "API Market for Antipsychotics," 2022.
[2] U.S. Food and Drug Administration (FDA), "Guidance for Industry: Contract Manufacturing Arrangements," 2018.
[3] International Council for Harmonisation (ICH), "Guidelines Q7 and Q11," 2019.
[4] European Medicines Agency (EMA), "Inspection Report Database," 2022.