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

METFORMIN HYDROCHLORIDE; SITAGLIPTIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Zydus Lifesciences	ZITUVIMET XR	metformin hydrochloride; sitagliptin	TABLET, EXTENDED RELEASE;ORAL	216778	NDA	Zydus Pharmaceuticals USA Inc.	70710-1804-6	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1804-6)	2024-10-31
Zydus Lifesciences	ZITUVIMET XR	metformin hydrochloride; sitagliptin	TABLET, EXTENDED RELEASE;ORAL	216778	NDA	Zydus Pharmaceuticals USA Inc.	70710-1805-6	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1805-6)	2024-10-31
Zydus Lifesciences	ZITUVIMET XR	metformin hydrochloride; sitagliptin	TABLET, EXTENDED RELEASE;ORAL	216778	NDA	Zydus Pharmaceuticals USA Inc.	70710-1806-3	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1806-3)	2024-10-31

Suppliers for the Pharmaceutical Drugs: Metformin Hydrochloride and Sitagliptin

Last updated: August 2, 2025

Introduction
Metformin Hydrochloride and Sitagliptin are cornerstone medications used in managing type 2 diabetes mellitus. Their widespread adoption necessitates a reliable, compliant, and scalable supply chain. The global pharmaceutical supply ecosystem comprises diversified manufacturers, generic drug producers, and contract manufacturing organizations (CMOs). This article explores the leading suppliers for both drugs, examining their manufacturing capacity, regulatory compliance, quality assurance, and market presence to ensure informed procurement and strategic sourcing decisions.

Metformin Hydrochloride Suppliers

Overview
Metformin Hydrochloride is one of the most prescribed oral antidiabetic drugs worldwide, with a long-standing approval profile. It is widely produced by generic manufacturers, given its patent expiry and high demand. Suppliers span Asia, Europe, and North America, with several tier-one producers supplying the global market.

Leading Suppliers

1. Hikma Pharmaceuticals
   As a recognized global generics manufacturer, Hikma supplies high-quality Metformin Hydrochloride, especially through its formulations in the Middle East, Europe, and North America. Their manufacturing facilities in Jordan and the UK comply with stringent GMP standards, ensuring quality and regulatory approval for multiple markets[^1].

2. Zhejiang Medicine Co., Ltd.
   This Chinese pharmaceutical giant is among the top bulk API suppliers for Metformin. Zhejiang Medicine’s API manufacturing facilities are certified by both Chinese authorities and international agencies, serving global needs via contractual arrangements[^2].

3. Hetero Labs Limited
   An Indian API producer with a significant share in the global Metformin supply chain, Hetero maintains ISO-certified facilities and supplies both API and formulation drugs globally. Their compliance with U.S. FDA, EMA, and other regulatory bodies enhances credibility[^3].

4. Mylan (now part of Viatris)
   Viatris, through its legacy Mylan operations, supplies Metformin API and formulations globally. Their robust GMP standards and extensive distribution channels bolster supply reliability[^4].

5. Lupin Limited
   A major Indian pharmaceutical company, Lupin produces Metformin API adhering to international quality standards. Its extensive export network supports global reach[^5].

Market Dynamics and Quality Considerations
Quality assurance remains paramount. Suppliers adhering to international regulatory standards (FDA, EMA, PMDA) are preferred. Many Asian manufacturers have achieved WHO-GMP and US-FDA approvals, making them suitable for markets with strict regulatory environments. Capacity and scalability are critical amid global demand, especially during health crises like the COVID-19 pandemic.

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Sitagliptin Suppliers

Overview
Introduced in 2006 by Merck & Co., Sitagliptin (marketed as Januvia) is part of the DPP-4 inhibitor class. Its specific synthesis process involves complex chemical pathways, resulting in a more limited manufacturing base compared to metformin. The patent expiry facilitated a competitive generic market, expanding global supply options.

Leading Suppliers

1. Zhejiang Chemsynthesis Co., Ltd.
   A Chinese specialty API producer with a focus on high-potency pharmaceuticals, Zhejiang Chemsynthesis supplies Sitagliptin to global markets. Their facilities carry approvals from Chinese regulators, with many products aligned with international standards[^6].

2. Hetero Labs Limited
   In addition to Metformin, Hetero produces Sitagliptin as a part of its portfolio. Their API production facilities are EU-GMP and FDA-certified, ensuring high purity and compliance[^3].

3. Aurobindo Pharma
   India-based Aurobindo is a leading manufacturer of generic APIs, including Sitagliptin. Their plants are registered with regulatory authorities globally, and they have demonstrated capacity to meet large-volume demands[^7].

4. Sun Pharmaceutical Industries
   Sun Pharma produces Sitagliptin API as part of its portfolio, supplying to both generic markets and regulated markets through multi-tiered manufacturing facilities[^8].

5. Biocon Limited
   An emerging player in biosimilars and generics, Biocon also supplies Sitagliptin API with an emphasis on quality and compliance, especially for Asian and Latin American markets[^9].

Regulatory and Quality Considerations
Sitagliptin’s complex synthesis constrains the number of high-quality suppliers. Suppliers with US-FDA ANDA approvals or EMA certifications are preferred for markets with stringent regulatory frameworks. Geopolitical stability, manufacturing capacity, and adherence to cGMP are critical factors influencing supplier selection.

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Comparative Market Insights and Trends

• Supply Chain Resilience: The COVID-19 pandemic accentuated vulnerabilities in global pharmaceutical supply chains. Suppliers with diversified manufacturing sites and validated regulatory compliance have demonstrated better resilience.
• Regulatory Harmonization: Suppliers equipped with multiple international regulatory clearances facilitate faster market access and reduce compliance risks.
• Quality & Certification: ISO, GMP, WHO-GMP, FDA, EMA, and other certifications underpin supplier credibility. Suppliers with these credentials are preferred.
• Pricing and Cost Factors: Asian suppliers, notably from India and China, often provide cost-effective APIs due to lower manufacturing costs, balanced with quality assurance.

Conclusion
The supply of Metformin Hydrochloride and Sitagliptin depends on a complex interplay of manufacturing capacity, regulatory compliance, quality standards, and geopolitical stability. The leading suppliers for Metformin are primarily Asian and Indian manufacturers with extensive global distribution channels, while Sitagliptin’s limited synthesis route constrains the vendor base to high-capacity, high-quality producers with international certifications. Strategic relationships with certified suppliers, coupled with ongoing quality audits, are essential to ensure reliable drug supply in a competitive and regulated environment.

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Key Takeaways

• The global supply chain for Metformin Hydrochloride is diverse, with key suppliers including Hikma, Zhejiang Medicine, Hetero, Mylan, and Lupin.
• For Sitagliptin, high-quality sources are primarily Asian manufacturers such as Zhejiang Chemsynthesis, Aurobindo, Sun Pharma, Hetero, and Biocon.
• Suppliers with international certifications (FDA, EMA, WHO-GMP) minimize compliance risks and facilitate market access.
• Diversification in sourcing and rigorous supplier qualification processes are crucial for supply chain resilience.
• Ongoing regulatory updates and geopolitical shifts impact the availability and stability of supplier relationships.

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FAQs

1. What are the key factors when selecting a supplier for Metformin or Sitagliptin?
Regulatory compliance (FDA, EMA, WHO-GMP), manufacturing capacity, quality assurance, certification standards, geopolitical stability, and cost are primary considerations.

2. Can suppliers from China and India meet the quality standards required for Western markets?
Yes. Many Asian manufacturers have achieved FDA and EMA approvals, with robust quality systems aligning with international standards.

3. How does patent expiry influence the supplier landscape for Sitagliptin?
Patent expiration has expanded the supplier base by enabling generic manufacturers to produce high-quality APIs, increasing competition and supply stability.

4. What risks are associated with over-reliance on a single supplier?
Supply disruptions due to regulatory issues, geopolitical factors, or manufacturing problems pose risks. Diversification mitigates dependency risks.

5. How do regulatory certifications impact the selection of suppliers for global markets?
Certifications like FDA, EMA, and WHO-GMP ensure products meet high-quality standards, reduce compliance hurdles, and facilitate faster market entry.

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Sources
[1] Hikma Pharmaceuticals, Company Reports, 2022.
[2] Zhejiang Medicine Co., Ltd. Official Website, 2023.
[3] Hetero Labs Limited, Annual Report, 2022.
[4] Viatris (formerly Mylan), Global API portfolio, 2023.
[5] Lupin Limited, Corporate Overview, 2022.
[6] Zhejiang Chemsynthesis, API Production Data, 2023.
[7] Aurobindo Pharma, Regulatory Approvals, 2023.
[8] Sun Pharmaceutical Industries, API Certification Details, 2022.
[9] Biocon Limited, Product Portfolio, 2023.