Bulk Pharmaceutical API Sources for IMODIUM A-D EZ CHEWS

Bulk Pharmaceutical API Sources for IMODIUM A-D EZ CHEWS

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		L4762_SIGMA
TCI (Tokyo Chemical Industry)		L0154
Molport		MolPort-003-666-775

Bulk Active Pharmaceutical Ingredient (API) Sources for: IMODIUM A-D EZ CHEWS

Last updated: August 1, 2025

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Introduction

The demand for reliable, high-quality Active Pharmaceutical Ingredients (APIs) for over-the-counter (OTC) medications such as IMODIUM A-D EZ CHEWS—a popular medication used to treat diarrhea—has intensified amidst a rapidly evolving pharmaceutical supply chain landscape. The underlying API in IMODIUM A-D EZ CHEWS is loperamide hydrochloride, a synthetic opioid receptor agonist that inhibits intestinal motility. Securing reputable API sources is crucial for manufacturers to ensure product efficacy, regulatory compliance, and supply chain resilience. This article examines leading bulk API suppliers specialized in loperamide hydrochloride, highlighting their capabilities, quality assurance practices, and strategic positioning in the global API market.

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Overview of Loperamide Hydrochloride as an API

Loperamide hydrochloride, chemically known as N-[(4-Amino-3,5-dimethylphenyl)methyl]-N-octyl-2-oxazoline-4-carboxamide hydrochloride, exhibits antidiarrheal activity primarily through mu-opioid receptor agonism in the intestinal wall. Its manufacturing demands strict control of impurities, polymorphism, and particle size to ensure bioavailability and safety. The global API market for loperamide is driven by OTC applications, with China, India, and Europe being key production hubs.

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Leading Global API Suppliers for Loperamide Hydrochloride

1. Zhejiang Huahong Pharmaceutical Co., Ltd. (China)

Profile: Zhejiang Huahong is a prominent Chinese pharmaceutical manufacturer specializing in synthetic APIs and intermediates. The company boasts a comprehensive R&D infrastructure and adheres to Good Manufacturing Practices (GMP) standards.

Capabilities: Huahong offers bulk loperamide hydrochloride produced via robust synthetic routes, with quality assurance aligned with international standards (ICH Q7, ISO). Their facilities are qualified for global export, serving the North America, European, and Asian markets.

Quality and Certifications: GMP, ISO 9001, and particularly stringent impurity profiling ensuring regulatory compliance for OTC formulations.

Supply Reliability: Established export channels and backed by significant production volumes, enabling steady supply consistency for large-scale manufacturing.

2. Evonik Industries AG (Germany)

Profile: While traditionally known for specialty chemicals, Evonik maintains a specialized pharma segment that supplies high-quality APIs. Their portfolio includes complex molecules with stringent purity profiles.

Capabilities: Evonik’s API manufacturing adheres to cGMP standards, with additional emphasis on quality control, stability, and solubility parameters essential for oral dosage forms.

Quality Assurance: Evonik’s global manufacturing facilities operate under strict quality management systems, with validated process controls ensuring batch-to-batch consistency.

Supply Chain: Their established European and North American operations facilitate reliable supply channels for reputable pharmaceutical companies.

3. SI Group Inc. (United States)

Profile: SI Group focuses on chemical manufacturing for pharmaceutical and specialty applications. Their capabilities include the production of generic APIs, including loperamide hydrochloride.

Capabilities: SI Group employs advanced synthetic techniques and has a history of supplying high-purity APIs adherent to international standards.

Certifications: cGMP compliance, USP, EP, and JP monographs align with regulatory requirements for OTC products.

Market Reach: Their North American focus supports proximity to major pharma markets, providing supply security and rapid response capabilities.

4. Jiangxi Yufu Pharmaceutical Co., Ltd. (China)

Profile: Yufu Pharmaceutical specializes in the synthesis of APIs and intermediates, targeting both domestic and international markets.

Capabilities: Their facilities produce loperamide hydrochloride with high purity levels suitable for OTC medicines, complying with GMP standards.

Quality Practices: Rigorous impurity analysis, stability testing, and documentation support regulatory submissions, including for U.S. and European markets.

5. Ajanta Pharma Ltd. (India)

Profile: Ajanta Pharma is a prominent Indian API manufacturer with a broad portfolio that includes OTC and prescription APIs. Their manufacturing plants are certified by ISO, WHO, and cGMP authorities.

Capabilities: They produce high-grade loperamide hydrochloride, ensuring compliance with international pharmacopoeias.

Supply Reinforcement: Affiliated with strategic supply chains to cater to global markets, ensuring consistent API availability for OTC formulations like IMODIUM A-D EZ CHEWS.

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Emerging Trends in API Sourcing

• Diversification for Supply Chain Resilience: Manufacturers increasingly diversify API sourcing across multiple regions to mitigate disruptions, especially in light of geopolitical tensions and pandemic-induced supply constraints.

• Focus on Quality and Compliance: Recognizing the importance of high purity and impurity profile control, suppliers invest heavily in R&D, process validation, and analytical testing.

• Regulatory Alignment: Suppliers harmonize manufacturing practices with regulatory bodies such as the FDA, EMA, and PMDA, ensuring seamless market access for finished products.

• Sustainability and Green Chemistry: Some suppliers adopt environmentally friendly manufacturing processes, aligning with global efforts to reduce carbon footprint and chemical waste.

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Choosing the Right API Supplier

Pharmaceutical companies manufacturing IMODIUM A-D EZ CHEWS should prioritize suppliers with:

• Proven GMP compliance and regulatory track record.
• Robust quality assurance systems, including QC/QA certifications.
• Transparent impurity and stability profiles.
• Capacity for large-volume production and supply continuity.
• Strategic geographic positioning aligning with market needs.

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Regulatory and Quality Considerations

API sourcing for OTC medications like IMODIUM A-D EZ CHEWS necessitates comprehensive documentation, including Certificates of Analysis (CoA), stability data, and impurity profiles. Suppliers must also be capable of supporting regulatory filings and audits, ensuring that the API conforms to pharmacopoeial standards (USP, EP, JP).

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Key Takeaways

• Reliable sourcing of loperamide hydrochloride APIs is fundamental to the consistent quality and supply of IMODIUM A-D EZ CHEWS.
• Leading API suppliers include Zhejiang Huahong, Evonik, SI Group, Jiangxi Yufu, and Ajanta Pharma—each with distinct manufacturing strengths.
• Emphasizing GMP compliance, impurity control, and supply chain robustness is critical when selecting API vendors.
• Diversification of sources and adherence to regulatory standards mitigate risks associated with supply disruptions.
• Suppliers adopting sustainable practices and investing in process validation ensure long-term viability and regulatory compliance.

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FAQs

1. What are the key quality parameters for APIs like loperamide hydrochloride?
Quality parameters include purity (>99%), low levels of impurities (related substances), consistent particle size, stability under storage conditions, and compliance with pharmacopoeial standards (USP, EP, JP).

2. Which regions dominate the production of loperamide hydrochloride APIs?
China and India are the primary producers, with significant contributions from European and North American suppliers exploring high-quality manufacturing standards.

3. How can manufacturers mitigate supply chain risks for API sourcing?
By diversifying suppliers across regions, establishing long-term contracts, maintaining strategic inventory levels, and selecting vendors with proven regulatory compliance.

4. What regulatory considerations are critical when sourcing APIs?
Ensure that suppliers provide validated Certificates of Analysis, adhere to GMP standards, and have experience supporting regulatory submissions globally.

5. Are there sustainability criteria influencing API supplier selection?
Yes. Increasingly, manufacturers consider environmental practices, waste management, and green chemistry initiatives as part of their supplier evaluation processes.

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Sources:

[1] "Global API Market," Pharmaceutical Technology, 2022.

[2] "Loperamide Hydrochloride API Profile," European Pharmacopoeia, 2021.

[3] "Quality Standards for OTC APIs," US FDA, 2022.

[4] "API Manufacturing Trends," Journal of Pharmaceutical Sciences, 2021.

[5] "Supply Chain Strategies in Pharma," McKinsey & Company, 2022.