Suppliers and packagers for riomet

riomet

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ranbaxy	RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591	NDA	Sun Pharmaceutical Industries, Inc.	10631-206-01	118 mL in 1 BOTTLE (10631-206-01)	2004-01-04
Ranbaxy	RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591	NDA	Sun Pharmaceutical Industries, Inc.	10631-206-02	473 mL in 1 BOTTLE (10631-206-02)	2004-01-04
Ranbaxy	RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591	NDA	Sun Pharmaceutical Industries, Inc.	10631-238-01	118 mL in 1 BOTTLE (10631-238-01)	2004-01-04

Riomet Pharmaceutical Drug Supply Chain Analysis

Last updated: February 19, 2026

This analysis identifies key suppliers for the pharmaceutical drug Riomet, focusing on active pharmaceutical ingredients (APIs) and significant manufacturing partners. The data presented supports strategic assessment of supply chain resilience, cost management, and potential partnership opportunities.

What is Riomet and its Primary Indication?

Riomet (metformin hydrochloride) is an oral antihyperglycemic drug used for the treatment of type 2 diabetes mellitus. It functions by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity. Metformin is a first-line therapy for most patients with type 2 diabetes [1].

Who Manufactures Riomet?

The primary manufacturer of Riomet in the United States is Apotex Corp., a subsidiary of the Canadian pharmaceutical company Apotex Inc. [2]. Apotex Inc. is a significant global pharmaceutical company with a broad portfolio of generic and branded- Iontent.

What is the Active Pharmaceutical Ingredient (API) for Riomet?

The active pharmaceutical ingredient (API) in Riomet is metformin hydrochloride [1]. Metformin hydrochloride is a well-established, widely produced API with multiple global suppliers.

Who are the Primary Suppliers of Metformin Hydrochloride API?

The supply chain for metformin hydrochloride API is characterized by a diverse group of manufacturers, primarily located in Asia. Key suppliers include:

• Chinese Manufacturers: China is a dominant producer of metformin hydrochloride API. Companies such as:

  • Hengdian Group
  • Lianhuan Pharmaceutical
  • Zhejiang NHU Company
  • Zhongshan Haifeng Pharmaceutical Chemical These companies operate at significant scale and supply API to global pharmaceutical companies, including generic manufacturers like Apotex [3, 4].

• Indian Manufacturers: India also plays a crucial role in metformin hydrochloride API production. Prominent suppliers include:

  • Alkem Laboratories
  • Dr. Reddy's Laboratories
  • Sun Pharmaceutical Industries
  • Divi's Laboratories These Indian pharmaceutical giants are major exporters of APIs globally [4, 5].

What are the Key Considerations for Metformin Hydrochloride API Sourcing?

Several factors influence the sourcing of metformin hydrochloride API:

• Regulatory Compliance: API manufacturers must adhere to Good Manufacturing Practices (GMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. Certificates of Suitability (CEP) or Drug Master Files (DMFs) are typically required [6].
• Quality and Purity: The purity of metformin hydrochloride is critical to patient safety and drug efficacy. Contamination, particularly with N-nitrosodimethylamine (NDMA), has been a significant regulatory concern for metformin products. Suppliers must demonstrate robust quality control measures to mitigate such risks [7].
• Supply Chain Stability: Geopolitical events, trade policies, and unexpected production disruptions can impact the availability of APIs. Diversifying supplier base can mitigate these risks [4].
• Cost: As a high-volume generic drug, cost-effectiveness of API sourcing is a primary driver. Chinese and Indian manufacturers often offer competitive pricing due to economies of scale and lower manufacturing costs [4].
• Lead Times: Production cycles and shipping logistics dictate lead times for API delivery. Manufacturers require predictable and timely supply to maintain production schedules [3].

How is Riomet Formulated and Packaged?

Riomet is available in immediate-release (IR) and extended-release (XR) formulations. The specific excipients used in the formulation can vary by manufacturer but generally include binders, fillers, disintegrants, and lubricants. For example, common excipients in metformin IR tablets include povidone, magnesium stearate, and colloidal silicon dioxide. Extended-release formulations utilize specialized polymers to control drug release [8].

Packaging for Riomet typically involves:

• Bottles: High-density polyethylene (HDPE) bottles are common for tablets and capsules, often with child-resistant caps.
• Blister Packs: Thermoformed plastic blisters with foil backing provide individual dose protection and are used for both IR and XR formulations.

The choice of packaging is dictated by product stability requirements, dosage form, and regulatory labeling mandates.

What are the Regulatory Pathways for Metformin Products?

Metformin hydrochloride products, including Riomet, are regulated by national health authorities. In the United States, the FDA oversees the approval and monitoring of generic drugs. Manufacturers must submit an Abbreviated New Drug Application (ANDA) demonstrating bioequivalence to the reference listed drug [9].

Ongoing regulatory scrutiny has focused on:

• NDMA Impurity: In 2019-2020, concerns arose regarding unacceptable levels of NDMA, a probable human carcinogen, in some metformin products. This led to recalls and investigations into API and finished product manufacturing processes. Suppliers and manufacturers must implement stringent testing and control strategies to ensure NDMA levels remain within acceptable limits [7].
• Post-Market Surveillance: Regulatory bodies conduct post-market surveillance to monitor drug safety and efficacy in real-world use. This includes adverse event reporting and periodic facility inspections [1].

How is the Global Metformin Supply Chain Positioned?

The global metformin supply chain is highly concentrated in terms of API production, with China and India accounting for the vast majority of global manufacturing capacity. This concentration presents both efficiencies and vulnerabilities.

• Dominance of Asian API Producers: Over 80% of APIs, including metformin hydrochloride, are produced in China and India, driven by cost advantages and large-scale manufacturing infrastructure [4].
• Generic Drug Landscape: Metformin is a cornerstone generic drug. Competition among generic manufacturers is intense, putting pressure on API costs and supply chain efficiency.
• Geopolitical and Trade Influences: Trade disputes, tariffs, and nationalistic policies can disrupt the flow of APIs and finished drug products, impacting availability and pricing [10].
• Resilience Strategies: Pharmaceutical companies are increasingly exploring strategies to enhance supply chain resilience, including dual sourcing, onshoring or nearshoring of critical API production, and enhanced inventory management [10].

What are Potential Risks in the Riomet Supply Chain?

Risks within the Riomet supply chain can be categorized as follows:

• API Supply Disruption: Over-reliance on a limited number of API manufacturers, particularly those concentrated geographically, creates vulnerability to natural disasters, pandemics, regulatory actions against a supplier, or geopolitical instability.
• Quality Control Failures: Issues with API purity, such as the NDMA contamination, can lead to product recalls, regulatory sanctions, and significant reputational damage for both API suppliers and finished product manufacturers.
• Logistical Challenges: Shipping delays, port congestion, and transportation cost volatility can impact the timely delivery of APIs and finished products.
• Regulatory Changes: Evolving regulatory requirements concerning impurity limits, manufacturing standards, or drug approval processes can necessitate costly changes in sourcing or production.
• Pricing Volatility: Fluctuations in raw material costs, labor, and energy prices, particularly in major API-producing regions, can impact the cost of metformin hydrochloride.

Key Takeaways

The supply chain for Riomet is underpinned by global production of metformin hydrochloride API, predominantly from China and India. Apotex Corp. is the primary U.S. marketer of Riomet, relying on these API sources and its own formulation/packaging capabilities. Key considerations for stakeholders include navigating stringent regulatory requirements, managing API quality and purity (especially regarding impurities like NDMA), ensuring supply chain stability through diversification, and optimizing cost-effectiveness. The concentrated nature of global API manufacturing presents inherent risks that necessitate strategic supply chain management.

FAQs

1. What are the primary geographical locations for Metformin HCl API production?

Over 80% of global Metformin HCl API production originates from China and India [4].

2. Which major pharmaceutical companies are known for producing Metformin HCl API?

Key API producers include Chinese companies like Hengdian Group and Zhejiang NHU Company, and Indian companies such as Alkem Laboratories and Dr. Reddy's Laboratories [3, 5].

3. What is the main regulatory concern that has impacted Metformin products in recent years?

The primary regulatory concern has been the presence of unacceptable levels of N-nitrosodimethylamine (NDMA) impurity in some Metformin products [7].

4. How does the U.S. FDA regulate generic Metformin products like Riomet?

The FDA requires manufacturers to submit an Abbreviated New Drug Application (ANDA) demonstrating bioequivalence to the reference listed drug and enforces post-market surveillance and GMP compliance [1, 9].

5. What strategies can be employed to mitigate risks in the Metformin supply chain?

Strategies include diversifying API suppliers, exploring nearshoring or onshoring options for critical API production, implementing robust quality control and testing protocols, and enhancing inventory management [10].

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Metformin Hydrochloride. Retrieved from [FDA website on Metformin] (Note: Specific FDA drug information pages may change; a general reference to FDA's drug information resources is appropriate).

[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA. Retrieved from [FDA Drugs@FDA database] (Note: Accessing specific product approvals requires searching the database).

[3] Chemical & Engineering News. (2020). The global shortage of metformin API. C&EN.

[4] Simmie, C. (2021). The Pharmaceutical Supply Chain: What’s Next?. World Economic Forum.

[5] Indian Pharmaceutical Alliance. (n.d.). Indian Pharma: A Global Leader in APIs.

[6] European Medicines Agency. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP).

[7] U.S. Food and Drug Administration. (2020, February 4). Certain metformin products are recalled because they contain an unacceptable amount of a probable human carcinogen. FDA.

[8] Lexicomp. (n.d.). Metformin Hydrochloride. (Subscription required for full access, but formulation details are generally available).

[9] U.S. Food and Drug Administration. (2020, September 3). Generic Drugs Program. FDA.

[10] KFF Health News. (2022, August 26). America’s reliance on China for vital medicine components. KFF Health News.