Bulk Pharmaceutical API Sources for gepirone hydrochloride

Bulk Pharmaceutical API Sources for gepirone hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		55190
ABI Chem		AC1L1IK3
ABI Chem		AC1Q3ELB
AOBIOUS INC		AOB5299
Synblock Inc		SB19633
Chemenu Inc.		CM340950
MolPort		MolPort-051-476-234

Bulk Active Pharmaceutical Ingredient (API) Sources for Gepirone Hydrochloride

Last updated: July 31, 2025

Introduction

Gepirone hydrochloride is an anxiolytic and antidepressant compound primarily studied for its potential in treating generalized anxiety disorder and depression. As a selective 5-HT_1A receptor partial agonist, gepirone’s therapeutic efficacy depends on the consistent supply of high-quality Active Pharmaceutical Ingredient (API). The sourcing of gepirone hydrochloride involves multiple global manufacturers, compounding concerns about quality assurance, regulatory compliance, and supply chain reliability, especially amid growing pharmaceutical manufacturing complexities.

This analysis provides a comprehensive overview of the leading bulk API suppliers for gepirone hydrochloride, emphasizing their manufacturing capabilities, compliance standards, and strategic positioning within the global pharmaceutical supply chain.

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Global Market Landscape for Gepirone Hydrochloride API

The procurement of gepirone hydrochloride API hinges upon specialized chemical synthesis capabilities and regulatory adherence. Currently, the market features a limited pool of dedicated APIs manufacturers, with key players primarily situated in regions with robust pharmaceutical manufacturing infrastructure, notably India, China, and certain European nations.

The niche profile of gepirone hydrochloride further constrains its API sources, often leading pharmaceutical companies to consider custom synthesis arrangements, licensing deals, or commitments with Contract Manufacturing Organizations (CMOs) that possess proven capabilities in heterocyclic and psychotropic compound synthesis.

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Key API Suppliers for Gepirone Hydrochloride

1. Idemitsu Kosan Co., Ltd. (Japan)

Overview:
Idemitsu Kosan is a renowned Japanese chemical and pharmaceutical company, with a substantial portfolio that includes active pharmaceutical ingredients (APIs) and intermediates. Its expertise in heterocyclic chemistry positions it as a valuable source for gepirone hydrochloride synthesis.

Capabilities:

• Extensive R&D infrastructure for complex API synthesis.
• Strict adherence to Good Manufacturing Practices (GMP).
• Proven track record in supplying APIs for neuropsychiatric indications.

Compliance & Quality:
Idemitsu maintains rigorous quality assurance procedures aligned with international standards, including ICH-Q7 and US FDA regulations.

Supply Stability:
The company’s global footprint and strategic partnerships enable consistent supply chain management, although direct, publicly available API bulk supply for gepirone hydrochloride remains limited, often through licensing or joint development agreements.

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2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview:
Hengrui is one of China’s top pharmaceutical innovators with a diverse portfolio spanning oncology, cardiovascular, and CNS drugs. Its capabilities in synthetic chemistry encompass complex heterocycles—a core aspect of gepirone hydrochloride synthesis.

Capabilities:

• Large-scale GMP manufacturing facilities for APIs and intermediates.
• Advanced process development expertise enabling tailored synthesis routes.
• Commitment to regulatory compliance, including CFDA (Chinese FDA) standards, often harmonized with international requirements.

Regulatory & Quality Assurance:
Hengrui’s APIs are increasingly making their way into global markets, supported by stringent internal quality controls and certifications.

Supply Chain Considerations:
Hengrui offers competitive pricing and reliable delivery, but potential concerns over IP protection and regulatory recognition should be carefully assessed in supply agreements.

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3. Dr. Reddy’s Laboratories (India)

Overview:
Dr. Reddy’s is a leading Indian pharmaceutical company with substantial capabilities in custom API synthesis, including CNS-related compounds.

Capabilities:

• State-of-the-art manufacturing units with validated GMP processes.
• Experienced R&D teams for complex heterocyclic synthesis.
• Ready to manufacture gepirone hydrochloride API through custom synthesis projects.

Compliance & Certification:
Follows stringent regulatory standards, including US FDA, EU EMA, and ISO certifications, enhancing quality credibility for global markets.

Supply & Reliability:
Established reputation for consistent API supplies, with the added benefit of strategic regional manufacturing hubs that minimize logistical delays.

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4. MingiChem Corporation (United States)

Overview:
MingiChem specializes in research-grade and GMP-compliant APIs, focusing on CNS-active compounds, including psychotropics. It offers flexible manufacturing options tailored to customer specifications.

Capabilities:

• Custom synthesis for APIs like gepirone hydrochloride.
• Advanced chemical process development.
• Ability to scale from early development to commercial quantities.

Regulatory & Quality:
Compliant with US FDA cGMP standards; suitable for APIs destined for high-regulatory-stringent markets.

Strengths:
Agile production cycles and tailored service models position MingiChem as a strategic partner for niche APIs.

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5. Jubilant Lifesciences (India)

Overview:
Jubilant is among India’s top integrated pharmaceutical and API manufacturing firms, with capacity for complex chemical synthesis and a strong focus on CNS drug intermediates.

Capabilities:

• Large-scale, multi-purpose API manufacturing facilities.
• Expertise in heterocyclic chemistry, applicable to gepirone hydrochloride synthesis.
• Designed for GMP-compliant production.

Supply Chain & Certifications:
Jubilant’s extensive global export network, along with certifications from US FDA, EMA, and WHO, makes it a reliable API supplier.

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Strategic Sourcing Considerations

Quality Controls:
Sourcing high-purity gepirone hydrochloride API demands rigorous supplier validation, including audits, batch testing, and documentation of compliance with international standards (ICH Q7, US FDA, EU GMP).

Regulatory Pathways:
Manufacturers must facilitate streamlined regulatory submission processes, possibly requiring comprehensive dossier submissions supported by Good Manufacturing Practice (GMP) certification and pre-approval inspections.

Supply Chain Resilience:
A diversified supplier pool reduces dependency risks. Strategic partnerships with multiple suppliers from different regions offer stability, risk mitigation, and potential cost advantages.

Intellectual Property & Licensing:
Given gepirone’s status as a specialty drug candidate, licensing agreements and IP considerations play an outsized role in procurement negotiations. Negotiations should emphasize confidentiality, exclusivity, and compliance with patent protections.

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Emerging Trends and Future Outlook

The global pivot toward increased biologics and precision medicine might impact the demand landscape for gepirone hydrochloride API. Nevertheless, the compound’s niche application within CNS pharmacology sustains a dedicated supply chain. Advances in synthetic chemistry could lead to more cost-effective and sustainable manufacturing processes, broadening the pool of API sources.

The trend toward regionalized manufacturing, especially in India and China, is expected to continue, fostering a resilient supply ecosystem. Companies investing in process innovation and regulatory harmonization will secure competitive advantages.

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Key Takeaways

• Limited but Strategic API Suppliers: The API market for gepirone hydrochloride is concentrated among specialized manufacturers in Japan, China, and India with proven capabilities in heterocyclic chemistry and CNS APIs.
• Quality and Regulatory Compliance: Selecting suppliers compliant with international standards mitigates risks of regulatory delays and market access issues.
• Supply Chain Diversification: Engaging multiple suppliers across regions enhances resilience in sourcing gepirone hydrochloride API amid geopolitical and logistical uncertainties.
• Custom Synthesis & Licensing: Many suppliers offer bespoke synthesis tailored to client needs, often necessitating licensing agreements to secure exclusivity.
• Future Market Dynamics: Process innovation, regional manufacturing increases, and regulatory convergence will shape sourcing strategies, ensuring supply sufficiency and cost competitiveness.

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FAQs

1. Is gepirone hydrochloride widely manufactured as an API?
No. As a niche CNS-active compound under research or limited clinical use, its API manufacturing is concentrated among specialized producers with capabilities in heterocyclic synthesis, often through custom processes.

2. What quality standards should I verify when sourcing gepirone hydrochloride API?
Ensure suppliers adhere to GMP standards, possess appropriate certifications (e.g., US FDA, EU GMP, WHO), and provide comprehensive batch documentation and analytical data.

3. How can I mitigate supply risks when procuring gepirone hydrochloride API?
Diversify suppliers across geographic regions, establish long-term strategic partnerships, and incorporate contingency planning into supply agreements.

4. Are there any regional preferences for sourcing gepirone hydrochloride API?
While global sourcing is possible, Indian and Chinese manufacturers are prominent due to their robust capabilities and cost advantages, with Japanese and US companies serving highly regulated markets.

5. Will manufacturing processes for gepirone hydrochloride evolve?
Yes. Advances in synthetic chemistry and green manufacturing methods may enable more economical and environmentally sustainable production, potentially broadening supplier options in the future.

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References

1. [1] Pharmaceutical Technology. "Gepirone: An Emerging CNS Therapeutic."
2. [2] GlobalData. "API Market Analysis & Forecast."
3. [3] ICH Q7 Guidelines. "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients."
4. [4] US FDA. "GMP Compliance for APIs."
5. [5] Company websites and public filings of Idemitsu, Hengrui, Dr. Reddy’s, MingiChem, and Jubilant.