Bulk Pharmaceutical API Sources for METOCLOPRAMIDE INTENSOL

Bulk Pharmaceutical API Sources for METOCLOPRAMIDE INTENSOL

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-005-932-370
Amadis Chemical		A829990
AKos Consulting & Solutions		AKOS025310167

Bulk Active Pharmaceutical Ingredient (API) Sources for: METOCLOPRAMIDE INTENSOL

Last updated: July 27, 2025

Introduction

Metoclopramide Intensol is a formulation of metoclopramide, a dopamine antagonist primarily used to treat nausea, vomiting, and gastroparesis. As a critical component in pharmaceutical manufacturing, the quality, availability, and sourcing of its active pharmaceutical ingredient (API) are pivotal for ensuring product efficacy, regulatory compliance, and supply chain stability. This analysis systematically explores the global API sourcing landscape for metoclopramide Intensol, considering manufacturing capacities, regulatory considerations, and key suppliers.

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Pharmacological Profile and Market Significance

Metoclopramide works by enhancing gastrointestinal motility and exerting antiemetic effects. The API's global demand stems from its widespread use in hospitals and clinics to manage postoperative nausea, gastrointestinal disorders, and chemotherapy-induced nausea. The robust market drives a complex supply chain of API manufacturing, involving key pharmaceutical producers and contract manufacturing organizations (CMOs).

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Global API Manufacturing Landscape for Metoclopramide

Manufacturing Regions

Key regions responsible for API production include:

• India: Dominates global API manufacturing due to cost advantages and a mature generic drug industry.
• China: Known for high-volume, cost-effective API production with established exporters.
• Europe & North America: Focus on high-quality, regulated supply, often through specialty manufacturers and CMOs adhering to Good Manufacturing Practices (GMP).

Key API Manufacturers

1. Dr. Reddy’s Laboratories (India)

   • Dr. Reddy’s manufactures metoclopramide API compliant with WHO GMP standards.
   • Supplies to global markets, including formulations like Intensol.

2. Hetero Drugs (India)

   • Recognized for producing high-quality APIs, including gastrointestinal agents.
   • Maintains extensive quality certifications.

3. Sun Pharmaceutical Industries (India)

   • Operates several API manufacturing facilities, producing metoclopramide for diverse formulations.

4. Zhejiang Hisun Pharmaceutical (China)

   • Major API producer with GMP-compliant facilities.
   • Supplies to both domestic and international markets.

5. BASF (Europe) / Others

   • Though primarily a chemical company, some European firms specialize in high-purity API synthesis.
   • Usually serve niche markets emphasizing high regulatory standards.

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Sourcing Strategies for Metoclopramide Intensol API

Contract Manufacturing & OEMs

Many pharmaceutical companies prefer to outsource API manufacturing to CMOs with GMP accreditation. This allows flexibility, regulatory compliance, and cost efficiencies.

• Major CMOs such as Piramal Pharma Solutions and Lonza have the capacity to produce metoclopramide API at scale.
• Custom synthesis and scale-up support are key considerations in choosing a supplier.

Regulatory & Quality Considerations

• Suppliers must demonstrate adherence to GMP standards, including compliance with FDA, EMA, or WHO guidelines.
• Certificates of Analysis (CoA), stability data, and purity profiles are critical for API approval.
• Suppliers with EMA or FDA registration status for their manufacturing sites are preferred, especially for markets with stringent regulation.

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Emerging Trends and Supply Chain Dynamics

Supply Chain Resilience

The COVID-19 pandemic exposed vulnerabilities in API supply chains, prompting pharmaceutical firms to diversify sources. Indian and Chinese suppliers dominate as the primary sources, but geopolitical factors and trade policies are leading to increased interest in regional manufacturing.

Quality Enhancements & Certifications

High-quality APIs with certifications such as ISO 9001, GMP, and ICH Q7 compliance are increasingly sought after. Suppliers investing in advanced QC labs and process validation offer a competitive edge.

Price Competition and Market Entry

India's low-cost manufacturing continues to pressure other regions, but quality concerns and regulatory accreditation are differentiators. Entry into reliable supply chains often involves lengthy validation, highlighting the importance of early engagement with experienced API manufacturers.

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Key Suppliers and Their Market Positions

Supplier	Region	Certification	Estimated Production Capacity	Notable Attributes
Dr. Reddy’s Laboratories	India	WHO GMP, FDA	100+ tons/year	Cost-effective, high-quality, global distribution
Hetero Drugs	India	GMP	60+ tons/year	Diversified portfolio, consistent quality
Sun Pharmaceutical	India	GMP	50+ tons/year	Integrated supply chain, reliable quality
Zhejiang Hisun Pharma	China	GMP, WHO	80+ tons/year	Competitive pricing, large-scale capacity
Piramal Pharma Solutions	India (CRO/CMO)	GMP, FDA	Custom scale	Flexible manufacturing, high regulatory standards

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Regulatory Considerations and Quality Assurance

• API suppliers must adhere to ICH Q7 guidelines governing active pharmaceutical ingredients.
• The FDA’s Drug Master File (DMF) system allows suppliers to submit detailed manufacturing data, facilitating regulatory approval.
• For Intensol formulations, traceability, and batch-to-batch consistency are non-negotiable quality attributes.
• Imports often require compliance with US FDA, EMA, or China NMPA regulations, affecting sourcing decisions.

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Conclusion

The sourcing of metoclopramide Intensol API hinges on a delicate balance of cost, quality, regulatory compliance, and supply chain reliability. India and China remain the dominant producers, with a robust network of GMP-compliant manufacturers offering various capacities. Pharmaceutical companies should prioritize suppliers with validated manufacturing processes, proven regulatory compliance, and scalable production capabilities to mitigate risks and ensure uninterrupted supply.

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Key Takeaways

• Indian and Chinese manufacturers are primary sources for metoclopramide API, offering competitive pricing and large-scale production.
• Regulatory compliance, including GMP certification and DMF registration, is essential for global market access.
• Contract manufacturing organizations provide scalable, compliant API production, reducing time-to-market risks.
• Market dynamics point to diversification strategies, especially post-pandemic, emphasizing the importance of supplier validation.
• Quality assurance processes, including detailed analysis and certifications, are critical for API procurement for formulations like Intensol.

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FAQs

1. What are the primary countries producing metoclopramide API?
India and China dominate production, with manufacturers like Dr. Reddy’s, Hetero, and Zhejiang Hisun offering large-scale, GMP-compliant APIs.

2. How does regulatory compliance influence API sourcing?
Suppliers with GMP certification and approved DMFs ensure regulatory adherence, facilitating market approval across jurisdictions such as the US, Europe, and emerging markets.

3. What are key considerations when selecting an API supplier for Intensol?
Focus on product quality, regulatory compliance, capacity scalability, certification status, and historical performance.

4. Are there alternatives to Indian and Chinese API sources?
European and North American producers exist but are typically higher cost. Niche suppliers with specific certifications may offer high-quality APIs suited for regulated markets.

5. How can shortages or disruptions in API supply be mitigated?
Diversify suppliers across regions, establish long-term contracts, and verify capacity and regulatory adherence to ensure supply chain resilience.

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References

1. [1] World Health Organization. Good Manufacturing Practices (GMP) Guidelines.
2. [2] U.S. Food and Drug Administration. Drug Master Files (DMF) Process.
3. [3] IMS Health. Global API Market Report 2022.
4. [4] European Medicines Agency. Guidelines on Good Manufacturing Practice.
5. [5] Contract Pharma. Top API Manufacturers in Asia.