CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879	NDA	Janssen Pharmaceuticals, Inc.	50458-940-01	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-940-01)	2016-09-20
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879	NDA	Janssen Pharmaceuticals, Inc.	50458-941-01	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-941-01)	2016-09-20
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879	NDA	Janssen Pharmaceuticals, Inc.	50458-942-01	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-942-01)	2016-09-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape is dynamic, emphasizing the importance of a reliable supply chain for core medications such as canagliflozin and metformin hydrochloride. These drugs play pivotal roles in managing type 2 diabetes mellitus. Ensuring access to high-quality supplies from reputable suppliers is essential for healthcare providers, pharmaceutical companies, and patients alike. This article provides an in-depth overview of key suppliers for both canagliflozin and metformin hydrochloride, highlighting their manufacturing capacities, geographical distribution, regulatory status, and market position.

Canagliflozin: Overview and Suppliers

Canagliflozin, marketed under the brand name Invokana among others, is an SGLT2 (sodium-glucose co-transporter-2) inhibitor manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. It functions by preventing glucose reabsorption in the kidneys, thereby lowering blood sugar levels. Due to its widespread adoption, multiple suppliers and manufacturers globally produce canagliflozin under various licensing and manufacturing arrangements.

Primary Manufacturers of Canagliflozin

1. Janssen Pharmaceuticals (Johnson & Johnson)

Market Position: Janssen is the original developer and sole patent owner of canagliflozin. The company’s manufacturing facilities are located primarily in the United States, with global distribution channels.
Supply Capabilities: Janssen maintains robust production capacity, ensuring global availability. Their manufacturing process adheres to strict Good Manufacturing Practices (GMP), ensuring product quality and consistency.
Regulatory Approvals: Fully approved by regulatory agencies including the FDA, EMA, and other major health authorities. Their supply reliability is backed by extensive clinical and regulatory validation.

2. Contract Manufacturing Organizations (CMOs)

Given patent expirations and the drug's patent life, several CMOs are authorized to produce generic or biosimilar versions, contingent upon regulatory approvals.

Dr. Reddy’s Laboratories: An Indian pharmaceutical giant with manufacturing capabilities for SGLT2 inhibitors, including canagliflozin, leveraging their extensive facilities across India.
Cipla: Also based in India, Cipla has demonstrated manufacturing capacity for various antidiabetic medications, including SGLT2 inhibitors, under licensing agreements.
Generics Manufacturers: Companies like Mylan (now part of Viatris) and Teva Pharmaceuticals have expressed interest in producing canagliflozin generics post-patent expiry, pending regulatory approval.

3. Emerging Global Suppliers

Sandoz (Novartis): Has ventured into manufacturing SGLT2 inhibitors, including tentative plans for biosimilars and generics, leveraging their global manufacturing footprint.
Mundipharma and Others: Smaller regional firms are exploring licensing agreements to manufacture and distribute canagliflozin in various markets.

Supply Considerations

Despite a strong manufacturing backbone from Janssen, the complex synthesis process of canagliflozin, which involves multi-step chemical processes, remains a bottleneck during supply chain disruptions. Additionally, the evolving landscape of biosimilars and patent challenges could influence future supplier diversity.

Metformin Hydrochloride: Overview and Suppliers

Metformin hydrochloride is a first-line oral antihyperglycemic agent extensively used worldwide. It was first marketed in the 1950s and remains the most prescribed antidiabetic medication globally. Its widespread use and affordability make the supply chain vital for the global healthcare system.

Major Suppliers of Metformin Hydrochloride

1. Multinational Pharmaceutical Companies

Lupin Pharmaceuticals: An Indian pharmaceutical producer with extensive manufacturing facilities for generics, including metformin hydrochloride. Lupin adheres to global regulatory standards (FDA, EMA) and supplies both branded and generic markets.
Sun Pharmaceutical Industries: India-based, with significant production capacity for metformin hydrochloride, producing both immediate-release and extended-release formulations.
Teva Pharmaceuticals: A dominant player in generics, with manufacturing units across Israel, India, and Europe, Teva supplies large quantities of metformin hydrochloride globally.

2. Asian Manufacturers

Hetero Labs: An Indian firm with ISO-certified manufacturing plants dedicated to various active pharmaceutical ingredients (APIs), including metformin.
Dr. Reddy’s Laboratories: With multiple manufacturing sites, Reddy’s supplies metformin to numerous markets. Their focus includes affordable generics for developing regions.
Jiangsu Hengrui Medicine (China): Confirmed to produce high-quality metformin APIs for both domestic and export markets.

3. Chinese API Suppliers

Chinese manufacturers dominate the API market for metformin owing to cost advantages and large-scale production capacity.

Wuhan Yarily Pharmaceutical: Supplies API to various international firms, complying with Good Manufacturing Practices (GMP).
Sino-American Pharmaceutical Company: An established API producer with consistent metformin batches meeting international standards.

Market Dynamics and Supply Chain Drivers

The global supply of metformin hydrochloride heavily depends on API manufacturing from India and China. During the COVID-19 pandemic, supply chain disruptions raised concerns regarding API shortages. Consequently, leading pharmaceutical companies strategically diversify their supplier base, sometimes establishing regional production hubs.

Regulatory and Quality Standards:
Suppliers must adhere to stringent GMP standards for APIs, particularly for active ingredients like metformin that are used in mass-produced medications. Regulatory agencies scrutinize manufacturing processes and supplier certifications to minimize risks of substandard or contaminated APIs infiltrating the supply chain.

Global Market and Regulatory Considerations

Patent and Exclusivity Status:
Canagliflozin’s patent landscape influences supplier options. With patent expiry anticipated or occurring in various jurisdictions, the market for generics expands, increasing supplier diversity. Conversely, metformin hydrochloride's original patent expired decades ago, fostering a broad, competitive manufacturing environment.

Regulatory Approvals and Quality Assurance:
Suppliers must secure approvals from agencies such as the FDA, EMA, and PMDA (Japan), among others. Due to the high volume of production and demand, governments and regulatory bodies continuously monitor supplier compliance, emphasizing the importance of Good Manufacturing Practices.

Supply Chain Risks:
Global geopolitical tensions, trade restrictions, and pandemics influence supply reliability. Suppliers with diversified manufacturing bases across multiple regions exhibit greater resilience, reducing risks associated with localized disruptions.

Emerging Trends in Supplier Landscape

Shift Towards Biosimilars and Generics: Patent expirations stimulate the entry of multiple generic manufacturers, increasing the number of suppliers especially for metformin hydrochloride, making the supply chain more competitive.
Vertical Integration and In-House Manufacturing: Major pharmaceutical companies are investing in in-house API production to secure uninterrupted supplies.
Technological Advancements: Innovations in chemical synthesis and process engineering allow smoother manufacturing of drugs like canagliflozin, aiding existing suppliers in meeting rising demand.

Conclusion

The supply landscape for canagliflozin and metformin hydrochloride reflects a complex interplay of patent status, manufacturing capabilities, regulatory compliance, and global market trends. Janssen remains the primary supplier for branded canagliflozin, with an expanding ecosystem of generic and biosimilar manufacturers poised to increase supply post-patent expiry. For metformin hydrochloride, Asia—particularly India and China—dominates API production, with numerous qualified suppliers ensuring broad access.

Ensuring supply chain robustness necessitates diversification, stringent quality assurance, and proactive regulatory oversight. Companies and healthcare providers should continuously monitor supplier standards and geopolitical developments to mitigate risks and sustain medication availability.

Key Takeaways

Janssen Pharmaceuticals remains the exclusive supplier of branded canagliflozin, with multiple CMOs poised for generic production pending patent and regulatory approvals.
India and China are the primary sources of metformin hydrochloride APIs, with reputable companies such as Lupin, Sun Pharma, and Jiangsu Hengrui leading global supply.
Regulatory compliance and GMP standards are critical benchmarks for supplier qualification, ensuring medication safety and efficacy.
Patent expirations are driving increased competition in the generics market for both drugs, improving market access and affordability.
Supply chain resilience hinges on diversification across regions and manufacturers, especially amid geopolitical and pandemic-induced disruptions.

FAQs

1. Who are the main suppliers of canagliflozin globally?
Janssen Pharmaceuticals is the sole producer of branded canagliflozin. Post-patent, various Indian and Chinese generic manufacturers, such as Dr. Reddy’s Laboratories and Cipla, are registered or developing generic versions.

2. Which countries dominate the manufacturing of metformin hydrochloride?
India and China are the leading producers of metformin APIs, with major pharmaceutical companies like Lupin, Sun Pharma, Wego, and Jiangsu Hengrui commanding significant market shares.

3. How does patent expiry affect the supply of these drugs?
Patent expiry opens the market for generics, resulting in increased supplier diversity and capacity, ultimately reducing costs and improving access.

4. What challenges face the supply chain for these medications?
Disruptions can originate from geopolitical tensions, manufacturing capacity constraints, regulatory delays, or global health emergencies, emphasizing the importance of diversification and quality assurance.

5. Are biosimilars or alternative drugs impacting the supply chain?
While biosimilars are more relevant for biologics, the increased availability of generics for small molecules like canagliflozin and metformin enhances market competition and supply security.

Sources

Johnson & Johnson. Invokana (canagliflozin) prescribing information.
Indian Pharmaceutical Association. Leading API manufacturers for antidiabetic drugs.
U.S. Food and Drug Administration. Approved Drug Products: Canagliflozin.
European Medicines Agency. Metformin hydrochloride information.
GlobalData. Market analysis reports on antidiabetic medications.

Suppliers and packagers for generic pharmaceutical drug: CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE