Bulk Pharmaceutical API Sources for REGLAN ODT

Bulk Pharmaceutical API Sources for REGLAN 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

Bulk Active Pharmaceutical Ingredient (API) Sources for REGLAN ODT: An Industry Overview

Last updated: July 28, 2025

Introduction

Reglan ODT (Oral Disintegrating Tablet), whose active pharmaceutical ingredient (API) is metoclopramide hydrochloride, is a widely prescribed medication for gastroparesis, GERD, and nausea. As with all pharmaceuticals, the quality, sourcing, and supply stability of the API are crucial for manufacturing, regulatory compliance, and market security. This report examines the current landscape of bulk API suppliers for metoclopramide hydrochloride, emphasizing sourcing channels, manufacturing hubs, regulatory considerations, and market dynamics.

Understanding Metoclopramide Hydrochloride as API

Metoclopramide hydrochloride acts as a dopamine antagonist promoting gastrointestinal motility. Its synthesis involves complex chemical processes, requiring high-quality raw materials, validated manufacturing procedures, and rigorous quality control to meet pharmacopeial standards such as USP and EP.

Global API Supply Chain for Metocramide Hydrochloride

Key Manufacturing Regions

Primary regions producing metoclopramide hydrochloride APIs include:

• India: The leading hub due to its robust pharmaceutical manufacturing infrastructure, cost advantages, and extensive API industry network.
• China: Growing presence with numerous GMP-compliant API producers, offering competitive pricing and large-scale manufacturing capabilities.
• Europe: Select high-quality manufacturers with strict adherence to GMP standards; however, supply tends to be more expensive.
• United States: Limited direct API manufacturing for metoclopramide, with reliance on imported APIs.

Major API Manufacturers:

• India-based Manufacturers:
  Companies like Jubilant Life Sciences, Laurus Labs, Hetero Labs, and Glenmark Pharmaceuticals dominate the Indian API market. They offer GMP-certified metoclopramide hydrochloride APIs, employed widely across generic formulations worldwide.

• Chinese Manufacturers:
  Numerous smaller producers and some larger entities such as North China Pharmaceutical Group Corporation (NCPC) provide competitive APIs, frequently with CE or ISO certifications.

• European and U.S. Suppliers:
  Limited manufacturing; many European and American pharmaceutical companies source APIs from India and China, emphasizing stringent quality standards.

Criteria for API Sourcing

When selecting suppliers for metoclopramide hydrochloride API, key criteria include:

• GMP Compliance: Ensures regulatory acceptance and batch-to-batch consistency.
• Regulatory Documentation: Certificates of Suitability, DMFs, and validation reports.
• Quality Specifications: Purity (>98%), residual solvents, impurity profiles.
• Supply Reliability: Production capacity, lead times, and stability.
• Cost-effectiveness: Competitive pricing balanced with quality.

Major API Suppliers for REGLAN ODT

Supplier Region	Notable Companies	Key Attributes
India	Jubilant Life Sciences, Laurus Labs, Hetero Labs	High GMP standards, broad API portfolio, established export channels
China	North China Pharmaceutical Group, Shandong Sanjing	Cost-effective, large production capacity, diverse product range
Europe	Sandoz (Novartis), Teva Pharmaceuticals	Strict quality standards, higher costs, niche supply sources
USA	Alpha Pharmacare (imported APIs)	Mainly import-dependent, emphasizes regulatory compliance

Supply Chain Challenges and Risks

• Regulatory Variability: Differing acceptance of API dossiers can delay approvals.
• Quality Assurance: Variability in manufacturing practices necessitates rigorous supplier validation.
• Supply Disruptions: Political, logistical, and global health crises (e.g., COVID-19) impact continuous supply.
• Pricing Fluctuations: Market dynamics influence API costs, affecting product pricing.

Future Outlook

The API sourcing landscape for metocramide hydrochloride remains poised for growth in India and China, driven by increased API manufacturing capacity and evolving regulatory frameworks. Initiatives towards Drug Master File (DMF) submissions and compliance with international standards will enhance supplier credibility. Additionally, sustained focus on supply chain robustness and localization may lead to diversified sourcing strategies.

Key Considerations for Industry Stakeholders

• Robust Due Diligence: Vet suppliers thoroughly for GMP compliance, quality control, and supply capacity.
• Strategic Diversification: Avoid over-reliance on a single source to mitigate risks.
• Regulatory Alignment: Ensure API dossiers align with target markets’ requirements for smooth registration.
• Cost-Benefit Analysis: Balance pricing advantages against quality and reliability factors.
• Long-term Partnerships: Foster relationships with reputable manufacturers for consistent supply.

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Key Takeaways

• The dominant sources for metoclopramide hydrochloride API are Indian, Chinese, and select European manufacturers.
• Indian API producers like Jubilant and Laurus Labs offer high-quality APIs, benefiting from established GMP practices and extensive export networks.
• Chinese manufacturers provide cost-efficient options, although due diligence is critical to ensure quality compliance.
• Supply chain risks necessitate diversification and rigorous supplier qualification.
• The evolving regulatory landscape demands transparency and compliance, favoring suppliers with well-documented quality systems.
• Future market stability depends on manufacturing capacity expansion, technological advances, and regulatory harmonization.

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Frequently Asked Questions

1. What are the leading countries for sourcing metoclopramide hydrochloride API?
India and China dominate due to their large-scale manufacturing capabilities, competitive pricing, and extensive export networks. Europe and the U.S. have limited domestic production, reliant on imports.

2. How do quality standards impact API sourcing decisions?
Stringent quality standards such as GMP compliance, validated processes, and detailed documentation are vital. Brands targeting regulated markets require APIs with recognized certifications like USP, EP, or DMFs on file.

3. What are the primary regulatory considerations when sourcing APIs?
Manufacturers must verify API dossiers, registration with pharmacopoeias, and adherence to local regulations. Regulatory agencies scrutinize purity profiles, impurity limits, and manufacturing practices.

4. How does API cost influence manufacturing decisions?
While cost is critical, it must be balanced with quality assurance and regulatory compliance. Lower-cost APIs from China may require additional validation, while Indian APIs often provide a balance of cost and quality.

5. What trends are shaping the API sourcing landscape for REGLAN ODT?
Increasing emphasis on GMP compliance, supply chain resilience, and regulatory harmonization pushes companies toward validated, well-documented suppliers in India and China. Additionally, trajectory towards local manufacturing in key markets may reshape sourcing strategies.

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References

1. U.S. Pharmacopeia (USP). Metoclopramide Hydrochloride Monograph. 2022.
2. Indian Pharmaceutical Industry Report, 2022. Indian Pharma Economy.
3. China Pharmaceutical Industry Yearbook, 2022. China Economic Publishing House.
4. European Pharmacopoeia, 10th Edition. 2021.
5. Global API Market Report, IQVIA, 2023.

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Note: This comprehensive overview aims to assist pharmaceutical industry professionals, formulators, and procurement specialists in making informed decisions on API sourcing strategies for REGLAN ODT.