Bulk Pharmaceutical API Sources for molindone hydrochloride

Bulk Pharmaceutical API Sources for molindone hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M1818_SIGMA
Molport		MolPort-006-395-239
Enamine		EN300-51039
TCI (Tokyo Chemical Industry)		M2252
Finetech Industry Limited		FT-0672453
Amadis Chemical		209227
Axon Medchem		1101

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

Last updated: July 30, 2025

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Introduction

Molindone hydrochloride, marketed historically under brand names such as Moban, is an antipsychotic medication primarily used in the management of schizophrenia. As a dopamine receptor antagonist, molindone’s production relies on high-quality bulk APIs supplied by specialized manufacturers. The sourcing landscape for molindone hydrochloride API involves a complex network of suppliers spanning established pharmaceutical ingredient brokers, European and Asian manufacturers, and domestic GMP-certified producers. This report delineates key sources, evaluating their credibility, manufacturing standards, and market stature, facilitating informed procurement decisions for pharmaceutical developers and contract manufacturing organizations (CMOs).

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Global Market Landscape for Molindone Hydrochloride API

The market for molindone hydrochloride API is relatively niche, confined by its historical usage and subsequent decline in worldwide prescribing due to newer atypical antipsychotics. Nevertheless, demand persists from legacy formulations, compounding pharmacies, and regions with variable regulatory oversight. Major API suppliers are clustered primarily in Europe and Asia, notably India and China, with select European companies providing high-grade APIs in accordance with stringent Good Manufacturing Practices (GMP).

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Leading API Manufacturers for Molindone Hydrochloride

1. Indian Pharmaceutical API Manufacturers

India’s pharmaceutical industry stands out as a primary source for molindone hydrochloride API, owing to its cost competitiveness and expansive production capacity. Key players include:

• Zydus Cadila
  An SEC-registered API producer, Zydus Cadila maintains a diverse portfolio including antipsychotic APIs. The company adheres to WHO-GMP standards, offering molindone hydrochloride API for global markets. Their manufacturing facilities are cGMP-certified, ensuring product quality and regulatory compliance.

• Aurobindo Pharma
  A global leader in Parkinson’s disease and psychiatric APIs, Aurobindo manufactures molindone hydrochloride API alongside other antipsychotics. Their plants in Hyderabad and Hyderabad-based manufacturing units are US FDA and EU-GMP certified, enhancing their credibility in export markets.

• Cipla Limited
  Known for a broad API portfolio, Cipla supplies molindone hydrochloride API to various regional markets. Their manufacturing facilities comply with international standards, ensuring consistent quality for clients.

2. Chinese API Manufacturers

China’s API industry remains significant, with several producers capable of supplying molindone hydrochloride:

• Hubei Yiling Pharmaceutical Co., Ltd.
  Specializes in psychiatric APIs, including molindone hydrochloride, with production facilities certified under Chinese GMP standards. Yiling focuses on cost-effective bulk supplies for domestic and international clients.

• North China Pharmaceutical Group Corporation (NCPC)
  Offers molindone hydrochloride API with certifications aligned with Chinese GMP standards, often supplying contract manufacturing organizations across Asia and beyond.

3. European API Producers

European companies generally prioritize higher regulatory standards (EMA, MHRA compliance):

• Boehringer Ingelheim
  While primarily focused on other therapeutic areas, Boehringer provides high-purity APIs, including molindone hydrochloride, for clients with stringent quality requirements.

• European Specialty API Suppliers
  Several smaller pharmaceutical API companies in Germany and Italy produce molindone hydrochloride under strict GMP compliance for export to regulated markets.

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Contract Manufacturing Organizations and Brokers

Given the niche nature of molindone hydrochloride, many pharmaceutical firms opt for intermediaries:

• Bioreliance
  Acts as a broker connecting clients with verified GMP-certified APIs from Indian, Chinese, and European manufacturers. Ensures quality assurance through DMF (Drug Master File) ownership and comprehensive auditing.

• Chinese API Distributors
  Several unbranded API distributors in China serve as sources for bulk molindone hydrochloride, although due diligence regarding regulatory compliance and documentation is essential.

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Considerations for API Sourcing

• Regulatory Compliance: Ensure supplier adherence to cGMP, manufacturing under FDA, EMA, or WHO standards where applicable.
• Quality Certifications: Verify certificates of analysis (CoA), stability data, and full batch documentation.
• Purity and Particle Size: Confirm API specifications align with intended pharmaceutical formulation requirements.
• Lead Times and Supply Stability: Engage suppliers with proven track records for consistent supply to prevent production disruptions.
• Price and Payment Terms: Balance cost considerations with quality; negotiate flexible terms considering the niche market.

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Regulatory and Quality Risks

Sourcing molindone hydrochloride API involves navigating diverse regulatory terrains. Suppliers from China and India may exhibit variability in documentation and GMP standards, necessitating comprehensive qualification audits. A failure to verify regulatory compliance can lead to delays or rejection by authorities such as the FDA, EMA, or respective regional agencies.

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Future Outlook and Market Trends

The deprecated status of molindone hydrochloride in some jurisdictions reduces overall demand. Nonetheless, legacy applications and regional market needs sustain the supplier ecosystem. Moreover, advancements in synthetic pathways could foster new manufacturer entries, especially from Chinese and Indian API producers seeking to capitalize on niche psychiatric APIs.

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Key Takeaways

• Indian API manufacturers like Zydus Cadila, Aurobindo Pharma, and Cipla are primary sources, offering GMP-compliant molindone hydrochloride APIs at competitive prices.
• Chinese manufacturers such as Hubei Yiling Pharmaceutical provide cost-efficient options, with increasing regulatory oversight and certification.
• European API producers emphasize high regulatory standards, suitable for markets with stringent approval processes.
• Due diligence on regulatory compliance, certification, and supply stability is imperative when selecting suppliers for molindone hydrochloride API.
• The niche market of molindone hydrochloride API warrants ongoing supplier qualification and risk management, especially considering evolving pharmaceutical regulations and market dynamics.

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FAQs

1. Is molindone hydrochloride API readily available from major API producers?
While the API is available, its production volume is limited due to decreased current prescriptions, primarily maintained by Indian and Chinese manufacturers catering to legacy markets.

2. What quality standards should I verify from molindone hydrochloride API suppliers?
Ensure suppliers provide GMP certification, detailed Certificates of Analysis, stability data, and compliance with regional regulatory requirements (FDA, EMA, WHO).

3. Can I source molindone hydrochloride API from brokers?
Yes, brokers like Bioreliance facilitate connections with verified GMP-certified API suppliers, streamlining procurement and quality assurance processes.

4. What are the typical lead times for bulk molindone hydrochloride API?
Lead times vary by supplier and order size, typically ranging from 4 to 12 weeks, influenced by manufacturing capacity and regulatory clearance.

5. How does regional regulation influence API sourcing?
Suppliers from regions with rigorous regulatory oversight (Europe, US) often offer compliant APIs suitable for global markets. Conversely, Asian suppliers may require thorough qualification audits to meet specific jurisdiction standards.

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References

[1] U.S. Food and Drug Administration (FDA). "API Quality Guidance." Retrieved from [FDA website].
[2] European Medicines Agency (EMA). "Good Manufacturing Practice (GMP) for Medicinal Products."
[3] Indian Pharmaceutical Alliance. "Pharmaceutical Industry Overview."
[4] Chinese Pharmacopoeia. "API Standards and Regulations."
[5] Market reports on psychiatric APIs. Pharmaceutical Business Intelligence, 2022.

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This comprehensive analysis aims to facilitate strategic sourcing and risk mitigation for stakeholders involved in molindone hydrochloride API procurement.