Bulk Pharmaceutical API Sources for MOTOFEN HALF-STRENGTH

Bulk Pharmaceutical API Sources for MOTOFEN HALF-STRENGTH

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemTik		CTK1C2422
Alsachim		1479
Chemieliva Pharmaceutical Co., Ltd		PBCM0522276
BenchChem		B1670552
Clinivex		RCLTRD445400
J&H Chemical Co.,ltd		JH271501
CymitQuimica		CQ_35607-36-4

Bulk Active Pharmaceutical Ingredient (API) Sources for: MOTOFEN HALF-STRENGTH

Last updated: August 1, 2025

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Introduction

Motofen Half-Strength, the branded variant of diphenoxylate hydrochloride combined with atropine sulfate, is a therapeutic agent primarily utilized for treating diarrhea. Its efficacy hinges on the quality and availability of its Active Pharmaceutical Ingredient (API), diphenoxylate hydrochloride. Ensuring a reliable supply of high-quality API is vital for pharmaceutical manufacturers aiming to produce effective, regulatory-compliant formulations. This article provides a comprehensive overview of current bulk API sources for diphenoxylate hydrochloride suitable for Motofen Half-Strength production, analyzing key suppliers, geographic considerations, and quality assurance standards.

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Understanding Diphenoxylate Hydrochloride as API for Motofen Half-Strength

Diphenoxylate hydrochloride acts as an antidiarrheal agent by reducing intestinal motility through opioid receptor activity. When combined with atropine sulfate, it enhances therapeutic efficacy while mitigating the risk of abuse. As a synthetic molecule, diphenoxylate's manufacturing hinges on complex chemical synthesis processes, requiring high purity APIs to ensure safety and effectiveness.

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Global API Manufacturing Landscape for Diphenoxylate Hydrochloride

The production of diphenoxylate hydrochloride predominantly occurs within established pharmaceutical chemical hubs in India, China, and certain European countries. Key criteria for API sourcing encompass:

• Manufacturing compliance with Good Manufacturing Practices (GMP)
• Certification and regulatory approvals (e.g., FDA, EMA, PMDA)
• Consistent API quality and batch-to-batch stability
• Competitive pricing and reliable supply chains
• Ethical sourcing and environmentally sustainable practices

Below are detailed evaluations of top bulk API suppliers for diphenoxylate hydrochloride.

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Leading API Suppliers for Diphenoxylate Hydrochloride

1. Jinan Pharma (China)

Overview: Jinan Pharma is recognized for its extensive portfolio of pharmaceutical intermediates and APIs, with a dedicated production line for controlled substances such as diphenoxylate.

Strengths:

• GMP-certified manufacturing facilities adhering to international standards
• Proven track record supplying to global generic and branded pharmaceutical companies
• Competitive pricing and high Purity Grades (≥ 99%)

Regulatory Status: Approved for export in various markets; certifications available upon request.

Key Considerations:

• Lead times vary depending on order volume
• Stringent QC protocols including HPLC and residual solvent analysis

2. Zhejiang Hisun Pharmaceutical (China)

Overview:
Zhejiang Hisun is a leading Chinese pharmaceutical manufacturer with significant capacity in APIs for gastrointestinal agents including diphenoxylate.

Strengths:

• robust GMP certification covering Chinese and international standards
• Vertical integration from synthesis to formulation support
• Extensive R&D capabilities, ensuring consistent product quality

Regulatory Compliance:

• Export experience to Europe, North America, and Asia
• Possesses valid drug master files (DMFs) for certain APIs

3. Sun Pharma Advanced Research Company (India)

Overview:
Known for innovative formulations and APIs, Sun Pharma’s API division supplies diphenoxylate hydrochloride suitable for Motofen production.

Strengths:

• ISO-certified manufacturing units
• Strong quality assurance mechanisms
• Integration within a global pharmaceutical network

Regulatory & Quality Assurance:

• Meets US FDA, European EMA standards
• Batch records and stability data available for audit purposes

4. Zhejiang NHU Co., Ltd. (China)

Overview:
Zhejiang NHU specializes in pharmaceutical intermediates and APIs, including controlled substances like diphenoxylate.

Strengths:

• Production facilities compliant with cGMP
• Diverse product portfolio and flexible manufacturing capacities
• Strong distribution network spanning Asia and Latin America

Quality Assurance:

• Regular third-party testing and batch qualification reports

5. HIKMA Pharmaceuticals (Jordan)

Overview:
HIKMA has a long-standing reputation in manufacturing APIs for gastrointestinal therapeutics, including diphenoxylate.

Strengths:

• Strict adherence to international quality standards
• Experienced in regulatory submissions
• Access to global markets through strategic partnerships

Certification & Compliance:

• CE Marking, FDA registration, and subsequent approvals

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Alternate and Emerging API Suppliers

• Lide Pharmachem (India): Smaller-scale manufacturer with competitive prices, suitable for bulk orders with strict quality controls.
• Sichuan Meiyuan Pharmaceutical (China): Focused on controlled substances, offering high-grade diphenoxylate hydrochloride APIs compliant with international regulations.
• American Peptide Company (USA): While primarily peptide-based, they have capabilities in small-scale chemical intermediates, including relevant APIs.

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Critical Quality Considerations

• Regulatory Certification: API suppliers must possess GMP certificates, DMFs, and relevant drug master files, especially for markets like the US, EU, and Japan.
• Purity & Identity: APIs should exhibit ≥99% purity, confirmed through HPLC, GC, and spectroscopic analyses.
• Impurity Profile: Low residual solvents, heavy metals, and process-related impurities are essential for safety compliance.
• Stability Data: Includes shelf-life specifications, stress testing outcomes, and packaging compatibility.
• Traceability: Clear documentation from raw material sourcing to finished product batch records ensures compliance and quality.

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Supply Chain and Risk Management

Many pharmaceutical companies face challenges with geopolitical factors, regulatory changes, and supply chain disruptions. Diversification of API sources, selecting suppliers with established compliance records, and maintaining safety stock are critical strategies to mitigate risks. Strategic partnerships with multiple qualified suppliers also help ensure uninterrupted production of Motofen Half-Strength.

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Conclusion

Securing a reliable bulk API source for diphenoxylate hydrochloride is pivotal for the consistent, high-quality production of Motofen Half-Strength. Leading suppliers in China, India, and Jordan offer validated, GMP-compliant APIs, each with their unique strengths in quality, regulatory compliance, and capacity. Due diligence in qualification, ongoing supplier audits, and quality assurance are essential for optimal supply chain performance.

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Key Takeaways

• Market Leaders: Jinan Pharma, Zhejiang Hisun, Sun Pharma, and Zhejiang NHU are prominent API suppliers with established GMP certifications and international market acceptance.
• Quality Assurance: Prioritize suppliers with comprehensive certification, rigorous testing, and transparent documentation adhering to global standards.
• Diversify Sources: Reducing dependence on a single supplier mitigates geopolitical and supply chain risks.
• Regulatory Compliance: Verify suppliers’ DMFs, regulatory approvals, and adherence to imported market standards for seamless distribution.
• Continuous Monitoring: Regular audits and quality checks ensure API batch consistency, maintaining the efficacy and safety of Motofen Half-Strength.

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FAQs

1. What are the primary considerations in selecting an API supplier for Motofen half-strength?
Quality compliance (GMP, DMFs), purity levels, batch consistency, regulatory approvals, supply reliability, and price competitiveness are key factors.

2. Are Chinese API manufacturers suitable for supply of diphenoxylate hydrochloride?
Yes, many Chinese manufacturers such as Jinan Pharma and Zhejiang NHU possess GMP certification and export approval, making them suitable for high-quality API supply.

3. How does regulatory compliance impact API sourcing?
Regulatory approval ensures that the API meets internationally recognized safety, purity, and efficacy standards, facilitating smoother registration and market access.

4. Is synthetic manufacturing of diphenoxylate hydrochloride scalable for commercial production?
Yes. Several suppliers have established scalable synthesis processes capable of supporting large-scale manufacturing demands.

5. What measures can ensure supply chain stability for diphenoxylate hydrochloride APIs?
Diversification of suppliers, maintaining safety inventories, ongoing supplier qualification, and establishing long-term contracts reduce supply disruptions.

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References

[1] U.S. Food and Drug Administration. (2022). Guidance for Industry: Validation of Analytical Procedures.
[2] European Medicines Agency. (2021). Good Manufacturing Practice and Inspection.
[3] Global Pharmaceutical API Market Analysis Report, 2022.
[4] Country-specific GMP and DMF databases.
[5] Manufacturer websites and certification documents (as referenced).

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