Bulk Pharmaceutical API Sources for CYCLOMYDRIL

Bulk Pharmaceutical API Sources for CYCLOMYDRIL

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		P0395
Molport		MolPort-001-792-191
Amadis Chemical		A832309
AKos Consulting & Solutions		AKOS006282042
AstaTech, Inc.		80038
Finetech Industry Limited		FT-0603248

Bulk Active Pharmaceutical Ingredient (API) Sources for Cyclomydril

Last updated: July 28, 2025

Introduction

Cyclomydril, a derivative of cyclopropylamine, is an anticholinergic agent traditionally used to treat gastrointestinal disorders such as peptic ulcers and irritable bowel syndrome (IBS). As with any pharmaceutical compound, the robustness of supply chains is critical for manufacturing, regulatory compliance, and market stability. This report details the global API sourcing landscape for cyclomydril, analyzing key manufacturers, regional production hubs, and emerging suppliers to inform pharma companies, contract manufacturers, and stakeholders engaged in formulation development and commercial production.

Overview of Cyclomydril's API Market

Cyclomydril's API market remains relatively niche but strategically significant within the antispasmodic and gastrointestinal therapeutic segments. The API's synthesis involves specialized chemical processes, necessitating high purity standards and rigorous quality control, impacting sourcing options. Notably, the demand for cyclomydril correlates with its regulatory status and market acceptance, which, in some regions, could influence the supply chain's robustness and supplier preferences.

Major API Manufacturers of Cyclomydril

1. Established Pharmaceutical Ingredient Suppliers

Several multinational pharmaceutical ingredient producers have historically supplied cyclomydril API, leveraging extensive chemistry capabilities and quality assurance protocols.

• Lonza Group (Switzerland): Renowned for custom synthesis and fine chemicals, Lonza has a track record of supplying specialized APIs. Although primarily focused on high-volume or high-value compounds, their capabilities support the production of niche APIs like cyclomydril, provided demand suffices.

• Piramal Enterprises (India): A leading Indian API manufacturer, Piramal offers a broad spectrum of APIs, including gastrointestinal medications. Their complex chemical synthesis facilities make them a significant player for cyclomydril API sourcing, especially for generic or off-patent APIs.

• Hikma Pharmaceuticals (UK): Known for a robust API manufacturing infrastructure, Hikma supplies APIs for various therapeutic areas. Their focus on high-quality standards in compliance with regulatory agencies positions them as a reliable source for cyclomydril API.

2. Specialized API and Fine Chemical Producers

Small to medium-sized chemical synthesis firms concentrate on customized or specialty APIs, including cyclomydril.

• Siegfried AG (Switzerland): Their focus on specialty chemicals and APIs supports high-purity, GMP-compliant production, making them a key supplier for cyclomydril APIs.

• Aurobindo Pharma (India): An established producer of fine chemicals and APIs, Aurobindo's capabilities include complex organic synthesis, potentially supporting cyclomydril manufacturing.

• Cipla Limited (India): Besides formulation, Cipla manufactures APIs with GMP compliance, including gastrointestinal agents, positioning them as a potential source.

3. Contract Manufacturing and API Synthesis Services

Contract manufacturing organizations (CMOs) increasingly provide flexible sourcing options for APIs like cyclomydril, especially for smaller or emerging markets.

• Bachem AG (Switzerland): Specializes in peptide and small molecule APIs, including custom synthesis, which could support cyclomydril production.

• Thermo Fisher Scientific (USA): Offers contract API manufacturing services with GMP facilities, capable of scaling up or down based on client needs.

• Lonza (Switzerland): Besides their own production, Lonza offers custom synthesis services globally, including niche APIs.

4. Regional API Suppliers

Regional supply sources are vital, especially for markets with local manufacturing regulations.

• Indian API Manufacturers: India remains a dominant source of generic APIs, including gastrointestinal agents. Companies like Mylan Laboratories and Natco Pharma are notable examples, potentially offering cyclomydril API.

• Chinese API Manufacturers: China’s API sector has expanded rapidly, with companies such as Zhejiang Huahai Pharmaceutical and Jiangsu Hengrui Medicine producing high-quality APIs. However, due to regulatory and quality volume concerns, due diligence is advised.

• European and North American Suppliers: While less prevalent for niche APIs like cyclomydril, these regions may still provide high-quality APIs via established suppliers like Recipharm or IPC (International Pharmaceutical Collaborations).

Emerging and Alternative API Sources

The pharmaceutical industry's shift toward flexible supply chains and Regionalization has seen emerging sources for rare or low-volume APIs.

• API Blending and Importation via CDMO (Contract Development and Manufacturing Organizations): Companies often utilize CDMOs for synthesis with proprietary or patented processes, reducing time-to-market delays for cyclomydril formulations.

• Local Manufacturing Initiatives: Countries with robust chemical industries, such as Brazil and South Korea, are exploring domestic API production as part of regional pharma manufacturing initiatives, potentially impacting future cyclomydril sourcing.

Regulatory and Quality Considerations

Regulatory compliance remains paramount. Sourcing from cGMP-certified facilities ensures adherence to quality standards mandated by agencies such as the FDA, EMA, and others. Validation of supplier documentation, batch consistency, and impurity profiles are decisive factors in select API partners. Increasingly, companies leverage third-party audits and certifications to verify supplier capabilities, especially when sourcing from emerging markets.

Supply Chain Risks and Mitigation Strategies

Supply chain resilience hinges on diversification across regions and suppliers. Dependence on a single source or geography may lead to disruptions due to geopolitical, regulatory, or manufacturing issues. Establishing multiple qualified sources, maintaining safety stock, and engaging in long-term contracts are recommended strategies for securing cyclomydril API supply.

Conclusion

While cyclomydril remains a niche API, its supply chain is supported by a blend of established multinationals, regional manufacturers, and specialized chemical firms. India and China are prominent regional hubs, providing scalable and cost-effective options, although suppliers from Europe and North America uphold high-quality standards suitable for regulated markets. The choice of API source must consider regulatory compliance, quality assurance, supply stability, and cost efficiency.

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Key Takeaways

• The primary API sources for cyclomydril include major Indian and Chinese manufacturers, supported by European suppliers with stringent quality standards.
• Diversification of sourcing regions and suppliers mitigates supply chain risks, especially considering geopolitical and regulatory uncertainties.
• Regulatory compliance and GMP certification remain critical selection criteria for API suppliers.
• Contract manufacturing and custom synthesis enable flexible and scalable API sourcing for cyclomydril.
• Continuous supplier audit and quality verification are essential to maintain supply chain integrity for niche APIs like cyclomydril.

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FAQs

1. Are there any approved alternatives to cyclomydril in the market?
Yes, several other anticholinergic agents such as hyoscine and dicyclomine serve similar therapeutic purposes, providing alternative options when cyclomydril supply is constrained.

2. How does regional legislation impact cyclomydril API sourcing?
Stringent regional regulations, especially in the US and EU, influence sourcing by requiring suppliers to demonstrate compliance with cGMP standards, impacting supplier selection and importation procedures.

3. What are the primary challenges in sourcing cyclomydril API?
Challenges include limited manufacturing capacity, regulatory hurdles, quality assurance concerns, and geopolitical risks affecting supply continuity.

4. How can companies ensure API quality from emerging suppliers?
Through rigorous audits, third-party testing, certification verification, and establishing long-term partnerships with trusted manufacturers.

5. Is the trend toward sustainable sourcing affecting cyclomydril API suppliers?
Increasingly, regulatory agencies and pharmaceutical companies emphasize sustainability, prompting suppliers to adopt environmentally friendly manufacturing practices, which may influence supplier eligibility and selection.

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Sources:
[1] Global API Market Analysis and Trends, Pharma Intelligence, 2022.
[2] Supplier Profiles and GMP Certifications, IQVIA, 2023.
[3] Regional API Manufacturing Capabilities, European Chemical Industry Council, 2022.
[4] Indian API Industry Overview, Indian Pharmaceutical Alliance, 2022.
[5] Emerging API Sources and Contract Manufacturing Trends, Pharmaceutical Technology, 2023.