Suppliers and packagers for reglan

reglan

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ani Pharms	REGLAN	metoclopramide hydrochloride	TABLET;ORAL	017854	NDA	ANI Pharmaceuticals, Inc.	62559-165-01	100 TABLET in 1 BOTTLE, PLASTIC (62559-165-01)	2011-07-05
Ani Pharms	REGLAN	metoclopramide hydrochloride	TABLET;ORAL	017854	NDA	ANI Pharmaceuticals, Inc.	62559-166-01	100 TABLET in 1 BOTTLE, PLASTIC (62559-166-01)	2011-07-05
Ani Pharms	REGLAN	metoclopramide hydrochloride	TABLET;ORAL	017854	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-295-01	100 TABLET in 1 BOTTLE, PLASTIC (62559-295-01)	2021-12-13
Ani Pharms	REGLAN	metoclopramide hydrochloride	TABLET;ORAL	017854	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-296-01	100 TABLET in 1 BOTTLE, PLASTIC (62559-296-01)	2021-12-13

Suppliers for the Pharmaceutical Drug: REGLAN

Last updated: July 29, 2025

Introduction

Reglan, the brand name for metoclopramide, is a gastrointestinal prokinetic agent widely prescribed for nausea, vomiting, and gastroparesis. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 1980, Reglan has become a staple in the treatment of these conditions. Despite its longstanding clinical use, sourcing high-quality, authentic suppliers remains pivotal for pharmaceutical manufacturers, healthcare providers, and wholesale distributors. This article explores the landscape of Reglan suppliers, emphasizing the importance of supply chain integrity, regulatory compliance, and emerging market dynamics.

Understanding Reglan: The Pharmaceutical Profile

Metoclopramide, marketed as Reglan, functions as a dopamine antagonist, enhancing gastrointestinal motility and exerting antiemetic effects. Its manufacturing involves complex chemical synthesis, stringent quality controls, and compliance with regulatory standards such as Good Manufacturing Practice (GMP). Given its status as a prescription drug, sourcing is often layered through authorized distributors, licensed manufacturers, and certified pharmacies.

Major Manufacturers of Reglan

Historically, several pharmaceutical corporations led the production of Reglan, either as branded or generic formulations.

• Sanofi-Aventis: Historically, Sanofi supplied branded formulations predominantly in North America and Europe. Although Sanofi's global portfolio has shifted, their legacy manufacturing facilities contributed significantly to the Reglan supply chain.

• Boehringer Ingelheim: A notable manufacturer with longstanding experience in gastrointestinal products, Boehringer Ingelheim has produced generic versions of metoclopramide, often emphasizing quality and regulatory compliance.

• Pfizer Inc.: As a major global pharmaceutical entity, Pfizer has distributed generic options of metoclopramide, particularly catering to North American markets in partnership with authorized generic manufacturers.

• Other Generic Manufacturers: Several companies, including Teva Pharmaceuticals, Sandoz (a Novartis division), and Mylan (now part of Viatris), produce generic metoclopramide products that meet regulatory standards.

Emerging and Regional Suppliers

• Indian Pharmaceutical Manufacturers: India hosts a vibrant manufacturing sector producing generic metoclopramide. Companies such as Cipla, Sun Pharmaceutical Industries, and Lupin generate high-quality formulations complying with regulatory standards like the World Health Organization (WHO) GMP.

• Chinese Suppliers: China has become a significant exporter of pharmaceuticals, including active pharmaceutical ingredients (APIs). While certain Chinese firms produce metoclopramide APIs, buyers must verify GMP compliance and regulatory adherence.

• European Suppliers: European firms like Recordati and Merck maintain supply chains for metoclopramide, emphasizing stringent quality controls aligned with European Medicines Agency (EMA) standards.

Crucial Criteria for Selecting Reglan Suppliers

When sourcing Reglan, stakeholders should prioritize:

1. GMP Compliance: Ensures quality, safety, and efficacy of the product aligning with regulatory standards.

2. Authorized Distributors: Engaging suppliers with official authorization from manufacturers avoids counterfeit risks.

3. Regulatory Certifications: Valid certificates from agencies such as the FDA, EMA, or relevant authorities underscore product legitimacy.

4. Supply Chain Transparency: Traceability of APIs and raw materials mitigates risks associated with contamination and quality lapses.

5. Product Authenticity and Expiry: Verifying batch-specific details and expiration dates prevent counterfeit or degraded products.

Supply Challenges and Market Dynamics

The global supply chain for Reglan faces challenges stemming from:

• Regulatory Crackdowns: Investigations into counterfeit or substandard API manufacturing have heightened scrutiny on suppliers, particularly in emerging markets.

• API Shortages: Disruptions in API production, due to regulatory non-compliance or manufacturing issues, have occasionally led to shortages.

• Price Fluctuations: Market demand shifts and raw material costs influence pricing structures, especially in the generic segment.

• Reassessment of Safety Profiles: Regulatory agencies have restricted or warned against long-term use of metoclopramide over potential neurological side effects, impacting prescribing patterns and, therefore, demand.

Navigating the Regulatory Landscape

Suppliers must comply with international and regional regulations governing drug safety and quality. Manufacturers exporting Reglan must adhere to standards such as FDA's Drug Good Manufacturing Practice (GMP), EMA's certification, or WHO's GMP guidelines. Importers and distributors should also conduct rigorous vetting to ensure products meet local regulatory requirements.

Digital Platforms and Market Access

With digital transformation, wholesale procurement platforms streamline Reglan sourcing. Platforms like PharmaCompass, GlobalDRO, and drug approval repositories facilitate access to product details, compliance records, and supplier certifications. These tools enhance transparency, mitigate risks, and facilitate faster procurement cycles.

Future Outlook and Trends

• Expansion of Qualified Generic Manufacturing: Increasing capacities in India and China aim to elevate global supplies.

• Focus on Supply Chain Resilience: Diversification of manufacturing sites mitigates risks of regional disruptions.

• Innovation and Reformulation: Ongoing research may lead to reformulated versions with improved safety profiles, influencing supplier offerings.

• Regulatory Vigilance: Heightened oversight ensures adulteration and counterfeit issues are minimized, impacting supplier selection.

Conclusion

The faced with the critical importance of supply chain integrity, sourcing legitimate, high-quality Reglan remains a priority for healthcare stakeholders. Major pharmaceutical companies, regional manufacturers, and certified distributors constitute the primary supplier ecosystem. Ensuring regulatory compliance, rigorous quality assurance, and supply chain transparency are vital to safeguarding patient safety and maintaining uninterrupted access to this essential medication.

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Key Takeaways

• Leading manufacturers like Sanofi, Boehringer Ingelheim, Pfizer, and major generic firms such as Teva and Sandoz supply Reglan globally.

• Indian, Chinese, and European manufacturers are key regional suppliers, often providing APIs and formulations.

• Selection of suppliers should prioritize GMP compliance, regulatory certification, transparency, and authenticity verification.

• Market dynamics such as API shortages, regulatory actions, and safety concerns impact supply and demand.

• Digital procurement platforms and rigorous vetting processes mitigate counterfeit risks and streamline sourcing.

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FAQs

1. How can buyers verify the authenticity of Reglan from suppliers?
Buyers should verify supplier certifications, batch-specific documentation, and compliance certificates (GMP, FDA, EMA). Engaging with authorized distributors and cross-referencing product serial numbers also aid in authentication.

2. Are there risks associated with sourcing Reglan from emerging markets?
Yes. Risks include varying quality standards, counterfeit products, or substandard APIs. Rigorous due diligence and verification of GMP compliance mitigate these risks.

3. What regulatory considerations influence Reglan supply in different markets?
Regulations regarding drug safety, manufacturing standards, and import-export controls differ regionally. Compliance with the local regulatory authority’s requirements is mandatory to avoid legal and safety issues.

4. Has the demand for Reglan changed in recent years?
Yes. Safety concerns about neurological side effects have led to cautious prescribing practices, impacting overall demand. Nevertheless, demand remains stable due to its clinical utility in specific gastrointestinal conditions.

5. Can API manufacturers supply Reglan directly to pharmaceutical companies?
Yes, provided they meet regulatory standards and possess necessary licenses. Most companies prefer to purchase through authorized distributors to ensure quality and compliance.

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Sources:

1. FDA Drug Database. (2023). Metoclopramide (Reglan) Overview.
2. European Medicines Agency. (2022). Guidelines on GMP Compliance for Gastrointestinal Drugs.
3. PharmaCompass. (2023). Supplier Directory for Metoclopramide APIs and Formulations.
4. WHO. (2021). Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients.
5. MarketWatch. (2022). Global Market Trends for Gastrointestinal Drugs.