Suppliers and packagers for MOLINDONE HYDROCHLORIDE

MOLINDONE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Epic Pharma Llc	MOLINDONE HYDROCHLORIDE	molindone hydrochloride	TABLET;ORAL	090453	ANDA	EPIC PHARMA, LLC	42806-336-01	100 TABLET in 1 BOTTLE (42806-336-01)	2018-10-17
Epic Pharma Llc	MOLINDONE HYDROCHLORIDE	molindone hydrochloride	TABLET;ORAL	090453	ANDA	EPIC PHARMA, LLC	42806-337-01	100 TABLET in 1 BOTTLE (42806-337-01)	2018-10-17
Epic Pharma Llc	MOLINDONE HYDROCHLORIDE	molindone hydrochloride	TABLET;ORAL	090453	ANDA	EPIC PHARMA, LLC	42806-338-01	100 TABLET in 1 BOTTLE (42806-338-01)	2018-10-17

Suppliers for the Pharmaceutical Drug: MOLINDONE HYDROCHLORIDE

Last updated: July 28, 2025

Introduction

Molidone hydrochloride, a typical antipsychotic agent classified as a typical neuroleptic, is primarily used in the treatment of schizophrenia and other psychotic disorders. Its pharmacological profile centers on dopamine D2 receptor antagonism, producing antipsychotic effects. Despite its diminished global use, molindone remains a relevant compound within the pharmaceutical landscape, often supplied by specialized chemical and pharmaceutical manufacturers. This analysis provides a comprehensive overview of current suppliers, sourcing avenues, and key considerations for procurement professionals.

Market Overview of Molindone Hydrochloride

Molindone hydrochloride belongs to the class of phenothiazine derivatives characterized by high potency and a relatively favorable side-effect profile compared to older antipsychotics (e.g., chlorpromazine). Its synthesis involves complex chemical processes, making supplier selection critical for pharmaceutical companies aiming for authenticity, purity, and regulatory compliance.

The global demand for molindone hydrochloride is relatively niche, limited mainly to regional markets and secondary pharmaceutical manufacturing. Consequently, suppliers operate within a specialized supply chain that emphasizes strict quality standards and Adherence to Good Manufacturing Practices (GMP).

Key Suppliers and Manufacturers

1. Specialty Chemical Suppliers

• Alfa Aesar / Thermo Fisher Scientific
  Alfa Aesar offers high-purity chemical standards and research-grade compounds, including molindone hydrochloride for laboratory and pharmaceutical development purposes. While primarily serving R&D, they act as a gateway for bulk procurement once development phases advance.

• Sigma-Aldrich (Merck Group)
  Known for an extensive catalog of pharmaceutical-grade chemicals, Sigma-Aldrich supplies molindone hydrochloride in research-grade quantities. Their strict quality control and compliance with international standards make their products suitable for clinical or manufacturing use, depending on regulatory status.

• Thermo Fisher Scientific / Fisher Scientific
  Thermo Fisher provides bulk chemical supplies to pharmaceutical manufacturers, including molindone hydrochloride, emphasizing high purity, consistency, and adherence to GMP.

2. Contract Manufacturing Organizations (CMOs) and Custom Synthesis Firms

• Pharmaceutical Contract Manufacturers
  Several CMOs worldwide offer custom synthesis and scale-up of molindone hydrochloride, often in compliance with internal quality specifications and regulatory standards. These manufacturers include companies such as:

  • PCI Synthesis (USA)
  • Helsinn Group (Switzerland)
  • LGM Pharma (USA)

  CMOs specializing in complex APIs can produce molindone hydrochloride at varying scales, ensuring steps like purification and stabilization meet regulatory standards for pharmaceutical applications.

• Asian API Manufacturers
  India and China host numerous API manufacturers capable of producing molindone hydrochloride, though due diligence regarding quality certifications and GMP compliance is essential when sourcing from these regions.

3. Theoretical and Licensed API Suppliers

• Global API Wholesalers
  Several international API distributors, such as Cayman Chemical or Toronto Research Chemicals, may supply molindone hydrochloride. These suppliers often cater to research and development, with limited or no authorization for direct pharmaceutical use.

• Licensed Pharmaceutical Companies
  Only a handful of companies are licensed to manufacture and distribute molindone hydrochloride for pharmaceutical use. Due diligence in verifying licensing, patents, and regulatory approval is critical to ensure legitimacy and compliance.

Regulatory and Quality Considerations

Procurement of molindone hydrochloride necessitates compliance with regulatory requirements such as the FDA, EMA, or relevant regional agencies. Suppliers must furnish Certificates of Analysis (CoA), Certificate of Suitability (CEP), or Drug Master Files (DMF) to assure quality, purity, stability, and GMP compliance.

When sourcing through international suppliers, especially from emerging markets, verifying Good Manufacturing Practice (GMP) certification and conducting site audits are prudent steps. For research and development use, suppliers with ISO certification endpoints may suffice.

Supply Chain Dynamics and Challenges

The limited number of global suppliers constrains supply and may introduce risk factors, including:

• Regulatory hurdles
  Licensing restrictions based on regional patent laws and drug approvals can limit supplier options.

• Price volatility
  Due to its niche status, molindone hydrochloride prices may fluctuate based on supply-demand dynamics, raw material costs, and geopolitical factors.

• Quality assurance
  Ensuring chemical purity and stability for pharmaceutical production demands rigorous supplier qualification processes.

• Regional availability
  Suppliers' geographic location impacts lead times, shipping costs, and regulatory compliance processes.

Emerging Trends in Supplier Sourcing

Advances in chemical synthesis and increased global collaboration have prompted some manufacturers to develop proprietary production methods for molindone hydrochloride, potentially offering better supply security and competitive pricing. The rise of API manufacturing hubs in India and China, under strict GMP accreditation, provides new sourcing options, but necessitates careful vendor qualification.

Additionally, the trend towards outsourcing and risk diversification encourages pharmaceutical companies to establish multiple sourcing channels, including partnerships with CMOs and authorized distributors.

Conclusion

For organizations seeking reliable suppliers of molindone hydrochloride, focusing on high-quality, GMP-compliant manufacturers—including reputable research chemical providers, CMOs, and licensed API manufacturers—is essential. Due diligence must include assessing supplier certifications, reviewing quality documentation, and ensuring regulatory compliance to mitigate risks associated with supply interruptions, substandard quality, or legal infringements.

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Key Takeaways

• Molindone hydrochloride supply primarily originates from specialized chemical and pharmaceutical manufacturers adhering to GMP standards.
• Key suppliers include Alfa Aesar, Sigma-Aldrich, and contract manufacturing organizations with capacity for custom synthesis.
• The global supply chain remains limited, emphasizing the importance of thorough supplier qualification.
• Regional manufacturers in India and China are increasingly prominent but require diligent quality assurance.
• Regulatory compliance, quality assurance, and supply chain resilience are critical factors influencing procurement strategies.

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Frequently Asked Questions

1. Is molindone hydrochloride available from major pharmaceutical suppliers?
Major chemical suppliers like Alfa Aesar and Sigma-Aldrich provide research-grade molindone hydrochloride, but pharmaceutical-grade API supply primarily comes from licensed manufacturers and CMOs equipped for clinical or commercial production.

2. What should I verify before sourcing molindone hydrochloride from a new supplier?
Verify GMP compliance, Certificates of Analysis, licensing status, stability data, and supplier audits. Confirm their presence of authorized manufacturing sites and adherence to regional regulations.

3. Are there regional differences in sourcing options for molindone hydrochloride?
Yes. North American and European markets typically access higher-regulated sources; Asian suppliers in India and China offer cost advantages but require careful validation of quality and regulatory compliance.

4. What are the challenges associated with sourcing molindone hydrochloride internationally?
Challenges include navigating differing regulatory standards, ensuring quality consistency, managing logistics, and assessing supply security due to limited global vendors.

5. Can molindone hydrochloride be synthesized in-house, or is external sourcing recommended?
In-house synthesis is complex and generally not practical for most pharmaceutical companies due to technical complexity and regulatory scrutiny. External sourcing from established, licensed suppliers is recommended to ensure quality and compliance.

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Sources
[1] "Molidone Hydrochloride," Sigma-Aldrich, accessed 2023.
[2] "Pharmaceutical APIs Market," IQVIA, 2022.
[3] "API Manufacturing in India," Indian Pharmaceutical Alliance, 2022.