Suppliers and packagers for generic pharmaceutical drug: metformin hydrochloride

metformin hydrochloride

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

Suppliers for the Pharmaceutical Drug: Metformin Hydrochloride

Last updated: July 27, 2025

Introduction

Metformin Hydrochloride stands as one of the most prescribed oral antihyperglycemic agents globally, primarily used for type 2 diabetes management. Originating from the French lilac (Galega officinalis), its synthesis and supply chain are highly sophisticated, involving multiple stages from raw material sourcing to final formulation. The global demand for metformin has surged with increasing diabetes prevalence, prompting a detailed analysis of its suppliers across the pharmaceutical supply chain.

This article comprehensively examines the principal suppliers of Metformin Hydrochloride, exploring raw material origins, active pharmaceutical ingredient (API) manufacturers, intermediates suppliers, and finished dosage form producers. Such insights are crucial for industry stakeholders aiming to secure supply security, ensure quality, and navigate regulatory landscapes effectively.

Raw Material Suppliers

Galega officinalis (Natural Sources)

Historically, the natural source of metformin’s precursors was Galega officinalis. However, today, natural extraction is largely obsolete in commercial production due to limited yield and lengthy processing cycles. Nonetheless, plant-derived materials still contribute to early-stage research or niche, eco-friendly manufacturing practices, often supplied by specialized botanical extract suppliers.

Chemical Intermediates for Synthetic Production

Modern metformin synthesis predominantly relies on chemical processes rather than natural extraction. Key raw materials include dimethylamine, chlorinated compounds, and相關 intermediates. Major chemical suppliers of these precursors include:

• BASF — A global leader supplying diverse chemical intermediates crucial for syntheses.
• Merck KGaA — Offers specialized chemicals used in pharmaceutical manufacturing.
• Lanxess — Provides chemical intermediates utilized in the synthesis of metformin precursors.

Active Pharmaceutical Ingredient (API) Manufacturers

Global Leaders in Metformin API Production

Large-scale API manufacturing is concentrated among a handful of international pharmaceutical and chemical companies, often operating in high-growth emerging markets to meet global demand for affordable generics.

• HNHP (Hetero Labs Ltd.)
  Hetero is a major Indian pharmaceutical company that supplies a significant proportion of metformin API globally. It offers high-quality APIs compliant with international standards, including USFDA, EMA, and MHRA certifications.

• Unichem Laboratories
  Also based in India, Unichem provides GMP-compliant metformin hydrochloride APIs, exporting to over 50 countries.

• Lupin Limited
  One of India’s top API producers, Lupin manufactures metformin in multiple formulations, emphasizing cost-efficiency and quality.

• Aurobindo Pharma
  Known for its extensive API portfolio, Aurobindo produces metformin with a focus on meeting global regulatory standards.

• Mylan (now part of Viatris)
  A leading international pharmaceutical firm with manufacturing facilities in India and Europe, providing metformin APIs for generic markets.

Regional Suppliers

Notably, China hosts multiple API manufacturers such as Shenzhen Hepalink Pharmaceutical Group and Hainan Yichen Pharmaceutical Co., which have expanded their metformin production capacities to serve both domestic and export markets, often at competitive prices.

Regulatory Certifications and Quality Standards

Suppliers with international regulatory approvals are preferred, enabling seamless market access. Many Indian and Chinese API manufacturers have achieved certifications such as USFDA, EMA, or ISO 9001, which affirm quality standards requisite for global supply.

Intermediate Suppliers

Intermediate chemicals, such as dimethylamine and chlorinated derivatives, are supplied by chemical manufacturers specializing in pharmaceutical-grade intermediates. Top suppliers include:

• E. I. du Pont de Nemours & Company — Known for high-purity intermediates.
• BASF and Lanxess — As noted earlier, supply essential intermediates used in the synthesis of metformin precursors.
• GFS Chemicals — A U.S.-based supplier known for custom chemical synthesis and specialty chemicals.

Finished Dosage Form Manufacturers

The final formulation of metformin hydrochloride tablets involves numerous companies worldwide, many of which are contract manufacturing organizations (CMOs). These companies package APIs into tablets and distribute under various generics and branded labels.

Leading Finished Product Producers

• Sun Pharmaceutical Industries — An India-based global generics giant manufacturing metformin tablets for multiple markets.
• Teva Pharmaceutical Industries — Offers a broad portfolio of metformin formulations, with manufacturing facilities worldwide.
• Mylan/Viatris — Produces and distributes various dosages, often through partnerships with regional manufacturers.
• Accord Healthcare — Supplies affordable metformin products, mainly for European and emerging markets.
• Cipla — Produces high-volume generic metformin formulations, particularly for African and Asian markets.

Emerging Market Dynamics

In regions like Southeast Asia, Latin America, and Africa, local manufacturers often source APIs from regional suppliers to produce cost-effective formulations, contributing to regional self-sufficiency.

Regulatory and Quality Considerations

Suppliers must meet stringent regulatory criteria to ensure product safety and efficacy. International certificates such as USFDA, EMA, and WHO prequalification are critical in supplier selection, especially for high-volume and export markets.

India dominates the API supply chain for metformin owing to its robust pharmaceutical manufacturing infrastructure, adherence to cGMP standards, and competitive pricing. Chinese suppliers, expanding rapidly, also play a pivotal role, especially in emerging markets.

Challenges and Market Trends

• Supply Chain Disruptions: Recent global events, such as pandemic-induced disruptions, have highlighted vulnerabilities in sourcing raw materials and APIs.
• Quality Assurance: Increasing demand for high-quality, compliant APIs has led to tighter regulatory scrutiny and supplier qualification processes.
• Pricing Pressures: Markets favor low-cost API and formulation suppliers, intensifying competition among Indian, Chinese, and regional manufacturers.
• Regulatory Compliance: Suppliers must continuously upgrade facilities and processes to meet evolving international standards.

Key Takeaways

• India and China serve as the primary hubs of metformin hydrochloride API manufacturing, driven by cost advantages and expanding capacities.
• Suppliers possessing strong regulatory certifications (USFDA, EMA, WHO prequalification) facilitate export into global markets.
• Chemical intermediates for metformin synthesis are sourced globally from established chemical suppliers, with quality control vital for API purity.
• Large pharmaceutical companies and CMOs dominate the finished drug production landscape, ensuring scalability and compliance.
• Ongoing supply chain resilience and quality assurance remain critical, especially amid geopolitical and pandemic-related challenges.

FAQs

1. Who are the leading API suppliers of metformin hydrochloride?
Indian pharmaceutical companies like Hetero Labs, Lupin, Aurobindo Pharma, and Mylan/Viatris top the list, complemented by Chinese manufacturers expanding their share.

2. Are there regional differences in metformin suppliers?
Yes. India and China are predominant suppliers globally, with regional manufacturers serving local markets in Latin America, Africa, and Southeast Asia.

3. What certifications should I look for when sourcing metformin APIs?
Manufacturers with USFDA, EMA, WHO prequalification, or ISO certifications ensure compliance with international standards.

4. How has COVID-19 impacted the metformin supply chain?
Pandemic disruptions have strained raw material and API availability, prompting companies to diversify supplier base and increase inventory buffers.

5. What are future trends in metformin supply chain management?
Enhanced regulatory standards, supply chain diversification, and sustainable manufacturing practices will shape future procurement strategies.

Sources

[1] Indian Pharmaceutical Industry Report 2022, Pharm Exec.
[2] GlobalAPI Market Insights 2021, IQVIA.
[3] WHO Prequalification Program, World Health Organization.
[4] Chinese Pharmaceutical Industry Data, China National Pharmaceutical Group.
[5] Regulatory Updates on Pharmaceutical Manufacturing, USFDA and EMA official websites.