Bulk Pharmaceutical API Sources for METOZOLV ODT

Bulk Pharmaceutical API Sources for METOZOLV ODT

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-005-932-370
Amadis Chemical		A829990
AKos Consulting & Solutions		AKOS025310167
BOC Sciences		54143-57-6
BOC Sciences		7232-21-5
MedChemexpress MCE		HY-17382A
AbaChemScene		CS-4323

Bulk Active Pharmaceutical Ingredient (API) Sources for: METOZOLV ODT

Last updated: July 29, 2025

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Introduction

Metozolv ODT, the oral disintegrating tablet formulation of metoclopramide hydrochloride, is a widely prescribed antiemetic and gastrointestinal motility enhancer. Its efficacy hinges on the quality and purity of the active pharmaceutical ingredient (API). Identifying reliable bulk API sources is crucial for pharmaceutical manufacturers, ensuring compliance with regulatory standards, cost efficiency, and supply chain stability. This comprehensive review explores global API suppliers for metoclopramide hydrochloride, elucidating sourcing strategies, regulatory considerations, and market dynamics.

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Overview of Metoclopramide Hydrochloride API

Metoclopramide hydrochloride, chemically known as (4-wyhydroxyphenyl)-N,N-dimethylglycinamide hydrochloride, facilitates gastrointestinal motility and antiemetic action. It is typically synthesized via multi-step chemical processes involving the condensation of 4-hydroxyphenylglycine derivatives and subsequent hydrochloride salt formation.

Given its complex synthesis and strict regulatory guidelines, sourcing high-quality APIs demands rigorous supplier evaluation, focusing on purity, bioavailability, batch consistency, and compliance with pharmacopeial standards.

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Global API Manufacturers for Metoclopramide Hydrochloride

1. Indian Pharmaceutical Manufacturers

India remains a dominant player in generic APIs, offering cost-effective, high-quality metoclopramide hydrochloride sources due to established manufacturing expertise and robust regulatory frameworks.

• Sun Pharmaceutical Industries Ltd.
  One of India's top pharmaceutical conglomerates, Sun Pharma manufactures a broad spectrum of APIs, including metoclopramide hydrochloride. Their facilities are approved by multiple regulatory agencies (USFDA, EMA), ensuring compliance and consistent supply. Their API meets USP and EP standards.

• Aurobindo Pharma Ltd.
  A major API and generic drug producer, Aurobindo offers metoclopramide hydrochloride API with extensive regulatory approvals. The company maintains rigorous quality control and adheres to international manufacturing standards.

• Lupin Limited
  Lupin manufactures APIs aligned with cGMP guidelines, providing high-purity metoclopramide hydrochloride suitable for pharmaceutical formulations. Their global presence supports supply continuity.

• Matrix Laboratories (now part of Mylan)
  Historically recognized for large-scale API production, Matrix supplied metoclopramide hydrochloride, with quality conforming to international pharmacopeial standards.

2. Chinese API Manufacturers

China remains a significant API supplier, with many producers offering competitive pricing and large production capacities.

• North China Pharmaceutical Group Corp. (NCPC)
  NCPC supplies metoclopramide hydrochloride APIs with GMP certification, adhering to pharmaceutical standards for quality and purity.

• Shandong Xinhua Pharmaceutical Co., Ltd.
  Known for producing various gastrointestinal API derivatives, their metoclopramide hydrochloride API is compliant with international standards.

• Shenzhen Hepalink Pharmaceutical Group Co., Ltd.
  As a WHO-GMP accredited supplier, Hepalink provides high-quality APIs, including metoclopramide hydrochloride, with extensive documentation for regulatory purposes.

3. European and US API Suppliers

While fewer in number due to stringent regulatory requirements, select European and US-based firms supply pharmaceutical-grade metoclopramide hydrochloride APIs.

• BASF SE (Germany)
  The chemical giant's API division offers high-grade chemicals suitable for pharmaceutical manufacturing, including metoclopramide hydrochloride, with comprehensive quality assurance.

• Cambridge Isotope Laboratories, Inc.
  Specializes more in isotopes and specialized compounds; however, they collaborate with European pharmaceutical producers for sourcing APIs meeting strict standards.

• Medichem S.A. (Spain)
  An established API manufacturer meeting EU-GMP standards, delivering pharmaceutical-grade metoclopramide hydrochloride.

Note: US-based sources for APIs tend to be limited primarily due to regulatory and manufacturing constraints, with most US companies acting as intermediaries or traders rather than primary manufacturers.

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Regulatory Considerations

Sourcing APIs for pharmaceutical production requires strict compliance with pharmacopeial standards (USP, EP, JP). Manufacturers must ensure that suppliers maintain cGMP compliance, possess validated manufacturing processes, and provide comprehensive Certificates of Analysis (CoA), stability data, and regulatory documentation.

For companies intending to export or market in regions like the US, EU, or Japan, API suppliers must have approved manufacturing facilities, and their APIs should meet the requisite pharmacopoeia monographs.

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Supply Chain Dynamics and Market Trends

The global API market is characterized by:

• Cost and Price Competitiveness: Indian and Chinese suppliers dominate with competitive pricing, though increasing regulatory scrutiny prompts supplier cGMP compliance enhancements.
• Regulatory Stringency: USFDA and EMA approvals are increasingly vital, influencing procurement decisions.
• Supply Reliability: Pandemic disruptions emphasized the importance of diversified sourcing, pushing companies to establish relationships with multiple suppliers across geographies.
• Quality Assurance: Suppliers offering advanced quality certifications (ISO, WHO-GMP, USFDA) are preferred to mitigate risks.

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Strategic Sourcing Recommendations

• Diversify suppliers: Establish relationships with multiple certified manufacturers across key regions.
• Verify regulatory compliance: Prioritize suppliers with proven adherence to cGMP, and recent regulatory approvals.
• Assess supply chain resilience: Include suppliers with proven logistics capabilities and contingency plans.
• Conduct audits: Regularly verify manufacturing practices and quality controls through site audits or third-party assessments.

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Conclusion

Reliable bulk API sources for metoclopramide hydrochloride are predominately found in India and China, with European suppliers offering high-compliance options. Sourcing should balance cost, regulatory compliance, quality, and supply chain resilience. As the demand for Metozolv ODT grows globally, maintaining a diversified, validated supplier base is essential for pharmaceutical manufacturers to ensure uninterrupted, high-quality formulation production.

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Key Takeaways

• Indian and Chinese pharmaceutical manufacturers are the primary bulk API suppliers for metoclopramide hydrochloride, offering cost-effective and compliant products.
• Regulatory compliance (GMP, USFDA, EMA approval) is critical when selecting API suppliers to mitigate regulatory risks.
• Diversifying API sources enhances supply chain resilience amidst geopolitical and logistical challenges.
• Regular audits and supplier validation fortify quality assurance and compliance.
• Evolving market dynamics demand ongoing supplier evaluation aligned with regulatory standards and technological advancements.

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FAQs

1. What factors should I consider when sourcing metoclopramide hydrochloride API?
Prioritize suppliers with strong regulatory compliance (GMP, USFDA, EMA), proven quality records, comprehensive Certificates of Analysis, and reliable supply chain logistics.

2. Are Chinese API manufacturers suitable for pharmaceutical-grade metoclopramide hydrochloride?
Yes, many Chinese API producers are GMP-certified and supply APIs that meet international pharmacopeial standards; however, thorough supplier validation and regulatory verification are essential.

3. How does regulatory approval influence API sourcing decisions?
Regulatory approvals (USFDA, EMA, WHO-GMP) ensure the API complies with strict quality standards, reducing risks of regulatory rejection, manufacturing issues, and market delays.

4. Can I source metoclopramide hydrochloride API directly from manufacturers?
Yes, but it often involves conducting thorough due diligence, establishing supply agreements, and ensuring compliance with applicable regulatory frameworks.

5. How can supply chain disruptions be minimized in sourcing APIs for Metozolv ODT?
Diversify your supplier base across multiple regions, verify manufacturing compliance, and establish contingency plans to manage geopolitical or logistical disruptions effectively.

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References

1. U.S. Pharmacopeia. Metoclopramide Hydrochloride Monograph.
2. European Pharmacopoeia. Metoclopramide hydrochloride.
3. Indian FDA. API Manufacturer Database [Online].
4. Chinese Pharmacopoeia. API Suppliers and Standards.
5. Industry Reports on Global API Market Trends, 2022.