Bulk Pharmaceutical API Sources for DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)

Bulk Pharmaceutical API Sources for DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D7909_SIGMA
Molport		MolPort-003-666-161
TimTec		SBB058148
TimTec		ST51014989
AKos Consulting & Solutions		AKOS015950777

Bulk Active Pharmaceutical Ingredient (API) Sources for: Dicyclomine Hydrochloride (Preservative-Free)

Last updated: November 13, 2025

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Introduction

Dicyclomine hydrochloride, a once-standard antispasmodic agent for gastrointestinal disorders, remains commercially significant despite the advent of newer drugs. As a selective anticholinergic agent, it primarily alleviates symptoms associated with irritable bowel syndrome (IBS), including abdominal cramping and motility issues. The pharmaceutical industry’s dependence on high-quality, preservative-free API sources is paramount for formulations intended for sensitive or preservative-avoidant patients. This report delineates available API suppliers, discussing their manufacturing capacity, quality standards, and strategic positioning within the global supply chain.

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Overview of Dicyclomine Hydrochloride API

Dicyclomine hydrochloride is a quaternary ammonium compound characterized by its anticholinergic activity. It is produced via multi-step chemical synthesis involving cyclization, alkylation, and salt formation, demanding stringent quality control given its physiological activity and formulation applications. The API's stability, purity, and documentation of compliance with pharmacopeial standards (USP, BP, EP) are prerequisites for global acceptance.

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Global API Suppliers for Dicyclomine Hydrochloride (Preservative-Free)

1. Major Manufacturers and Market Leaders

a) Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

• Capabilities: One of the leading Chinese pharmaceutical manufacturers with extensive API production facilities compliant with GMP standards. Huahai’s portfolio covers various gastrointestinal drugs, including dicyclomine hydrochloride.
• Quality Assurance: Certifications include GMP, ISO 9001, and audits aligned with ICH guidelines.
• Supply Capacity: Significant, with annual output in the metric ton range; supplies to global markets, including North America, Europe, and Asia.
• Product Quality: Meets USP and EP specifications; the API is preservative-free, suitable for sterile and sensitive formulations.

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

• Capabilities: Well-established with modern synthesis and purification technologies.
• Quality & Compliance: GMP-certified, with robust R&D for API optimization ensuring high purity (>99%) and low residual solvents.
• Delivery: Reliable, with a flexible supply chain capable of fulfilling large orders.

c) Aarti Drugs Ltd. (India)

• Capabilities: Focused on gastrointestinal APIs, including dicyclomine hydrochloride, with state-of-the-art manufacturing and extensive R&D.
• Quality Assurance: GMP, ISO 9001, and cGMP compliant.
• Standards: API conforms to pharmacopoeial standards (USP, BP) and is packaged preservative-free.

d) Synthesis Laboratories (USA/India)

• Positioning: Smaller niche supplier with emphasis on high-purity, preservative-free APIs.
• Specialization: Custom synthesis and high-potency APIs, including those suitable for sterile preparations.
• Compliance: Good Manufacturing Practices (GMP) and comprehensive documentation.

2. Emerging and Specialty API Producers

a) Alfa Aesar (Thermo Fisher Scientific)

• Overview: Supplies pharmaceutical-grade APIs produced via licensed processes.
• API Quality: Ensures preservative-free formulations fulfilling USP and EP monographs.
• Availability: Readily accessible via global distribution channels.

b) Jiangsu Nhwa Pharmaceutical Co., Ltd.

• Expertise: Focused on gastrointestinal and central nervous system APIs.
• Standards: GMP-compliant, with consistent product quality and reliable supply.

c) Hunan ZDouble Pharmaceutical Co., Ltd.

• Niche: Focus on generic APIs with flexible manufacturing capacity.
• API Standards: Meets international pharmacopeial standards for preservative-free bulk APIs.

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Key Considerations for Sourcing Dicyclomine Hydrochloride API

Quality & Compliance:
Select suppliers certified by recognized regulatory agencies (e.g., FDA, EMA, PMDA). Ensure APIs meet USP, EP, BP monographs, and are free from preservatives, especially when intended for sensitive formulations.

Manufacturing Capacity:
Suppliers with scalable manufacturing capabilities can accommodate large orders and rapid delivery schedules. Flexibility during supply disruptions, such as global shortages, is critical.

Traceability & Documentation:
Comprehensive Certificates of Analysis (CoA), batch records, and stability data are mandatory for quality assurance, regulatory filings, and batch consistency.

Price & Supply Chain Stability:
While cost is essential, reliability and consistent quality supersede price considerations. Long-term agreements with trusted suppliers mitigate risks associated with price volatility and supply interruptions.

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Regulatory Landscape and Considerations

The regulatory approval of API suppliers hinges on adherence to Good Manufacturing Practices (GMP) and compliance with international pharmacopeia standards. Suppliers must furnish complete documentation, including stability studies, impurity profiles, and manufacturing process validation for regulatory submissions.

The global API market has seen increased scrutiny post-2019 with supply chain disruptions exacerbated by geopolitical tensions and pandemic-related constraints. Consequently, diversification of suppliers—particularly sourcing from reputable manufacturers in China, India, and established Western firms—has become mainstream.

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Conclusion

Owing to its significant therapeutic niche, high-quality, preservative-free dicyclomine hydrochloride raw material is available from a diversified base of reputable manufacturers worldwide. China and India dominate supply due to their large-scale API manufacturing capabilities, with strict adherence to GMP and international standards. Niche and premium suppliers in North America and Europe also serve specialized markets requiring high-purity, traceable API sources, especially for sterile formulations. Strategic procurement should prioritize supplier compliance, capacity, and supply chain resilience to ensure continuity and regulatory compliance.

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Key Takeaways

• Major API producers such as Zhejiang Huahai and Jiangsu Hengrui provide high-quality, preservative-free dicyclomine hydrochloride, with proven GMP certification and broad market presence.
• Indian manufacturers like Aarti Drugs also serve as reliable sources, emphasizing cost-effectiveness and compliance.
• Regulatory compliance and detailed documentation (CoA, stability data) are non-negotiable criteria when selecting API suppliers.
• The global API supply chain's resilience hinges on supplier diversity, capacity, and adherence to evolving regulatory standards.
• Manufacturers with proven GMP standards and flexible supply capabilities are critical partners in ensuring uninterrupted access to high-purity dicyclomine hydrochloride for pharmaceutical formulations.

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FAQs

Q1: What are the leading countries producing preservative-free dicyclomine hydrochloride API?
A1: The primary producers are China, India, and the United States, with China and India dominating large-scale manufacturing due to cost advantages and extensive APIs portfolios.

Q2: How can I verify the quality of API suppliers for regulatory compliance?
A2: Confirm GMP certification, review Certificate of Analysis (CoA), and ensure compliance with pharmacopeial standards such as USP and EP. Audits and supplier qualification programs further validate quality.

Q3: Is there a difference between preservative-free and preserved APIs?
A3: Yes. Preservative-free APIs are manufactured without adding preservatives, essential for formulations sensitive to preservatives or used in sterile applications to minimize potential irritation or allergic reactions.

Q4: What factors influence API pricing in the global market?
A4: Factors include manufacturing scale, raw material costs, regulatory compliance, quality standards, geopolitical stability, and supply chain logistics.

Q5: Are there specific regulatory concerns with sourcing dicyclomine hydrochloride from Chinese manufacturers?
A5: While many Chinese manufacturers are GMP-compliant, due diligence—including audits, certifications, and regulatory verification—is advisable to ensure quality and compliance, especially for export markets like the US and EU.

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References

[1] United States Pharmacopeia (USP). Dicyclomine Hydrochloride monograph.
[2] European Pharmacopoeia (EP). Dicyclomine Hydrochloride monograph.
[3] Global API market reports. IQVIA, 2022.
[4] Official websites of Zhejiang Huahai Pharmaceutical, Jiangsu Hengrui Medicine, Aarti Drugs.
[5] International GMP guidelines, ICH Q7 for Active Pharmaceutical Ingredients.