Suppliers and packagers for flagyl

flagyl

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	FLAGYL	metronidazole	CAPSULE;ORAL	020334	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1942-34	100 BLISTER PACK in 1 CARTON (0025-1942-34) / 1 CAPSULE in 1 BLISTER PACK	1995-05-03

Suppliers for the Pharmaceutical Drug: Flagyl (Metronidazole)

Last updated: July 30, 2025

Introduction

Flagyl, with the generic name metronidazole, is an antibiotic and antiprotozoal medication widely used for treating various infections, including bacterial vaginosis, trichomoniasis, giardiasis, and anaerobic bacterial infections. Its global demand necessitates a robust supply chain comprising multiple manufacturers and distributors.

This article provides a comprehensive overview of key suppliers for Flagyl, exploring approved manufacturers, supply chain dynamics, and market trends essential for stakeholders involved in procurement, manufacturing, or regulatory oversight.

Global Manufacturing Landscape

The production of metronidazole, branded as Flagyl, predominantly occurs across licensed pharmaceutical companies spanning North America, Europe, Asia, and other regions. These manufacturers typically operate under stringent regulatory standards, such as the FDA in the United States, EMA in the European Union, or the PMDA in Japan.

Major Approved Manufacturers

1. Sanofi-Aventis (France)
   As the original patent holder, Sanofi supplies Flagyl globally. Their manufacturing facilities in France produce high-quality formulations approved by various regulatory agencies, maintaining a dominant position in the market.

2. Mitsubishi Tanabe Pharma Corporation (Japan)
   Mitsubishi Tanabe manufactures metronidazole for both domestic and international markets, emphasizing compliance with Good Manufacturing Practices (GMP).

3. Zhejiang Jiuxian Pharmaceutical Co., Ltd. (China)
   A leading Chinese generic pharmaceutical producer, Zhejiang Jiuxian supplies biosimilar and generic formulations, including metronidazole.

4. MSD (Merck & Co.)
   MSD markets metronidazole in certain regions, primarily in North America, with manufacturing facilities compliant with U.S. regulatory standards.

5. Hunan Jiangsu Pharmaceutical Co., Ltd. (China)
   Specializing in bulk API production, this Chinese manufacturer supplies metronidazole API to multiple pharmaceutical companies globally.

6. Apotex Inc. (Canada)
   A reputable generic pharmaceutical manufacturer, Apotex produces formulations and supplies API for metronidazole, especially within North America.

7. Taj Pharmaceuticals Ltd. (India)
   A significant player in API and formulations, Taj Pharmaceuticals exports metronidazole to various markets worldwide.

8. Aurobindo Pharma (India)
   Renowned for generic APIs, Aurobindo supplies both API and finished formulations of metronidazole globally and within India.

9. Torrent Pharmaceuticals (India)
   With a focus on both API and formulations, Torrent is a significant supplier of metronidazole to several international markets.

10. Cipla Ltd. (India)
    Known for its comprehensive portfolio, Cipla manufactures and supplies metronidazole in various pharmaceutical forms.

Emerging Suppliers and Market Trends

The generic drug segment has flourished, especially in India, China, and Southeast Asia, driven by increasing demand for affordable medications. Many manufacturers have expanded capacities or entered the market to meet global needs, especially amid increased health crises and the push for cost-effective treatment options.

API Manufacturers and Supply Chain Considerations

Metronidazole's API (Active Pharmaceutical Ingredient) is critical for formulation. Several companies producing high-purity API include:

• Hunan Jiahua Pharmaceutical Co., Ltd. (China)
• Sun Pharmaceutical Industries Ltd. (India)
• Lianyungang Ledu Pharmaceutical Co., Ltd. (China)
• Aarti Drugs Ltd. (India)

Quality and regulatory compliance are pivotal for API suppliers. Manufacturers must meet WHO GMP standards or equivalent, and API derived from these sources feeds into both generic and branded drug manufacturing.

Regulatory and Quality Assurance

Suppliers must adhere to rigorous quality assurance measures, including batch testing, stability assessments, and compliance with pharmacopeial standards such as USP, EP, or JP. The complexity of manufacturing APIs and formulations necessitates thorough documentation and regulatory approval before entering markets, particularly in highly regulated regions like the USA, EU, and Japan.

Market Access and Distribution Channels

Distribution channels for Flagyl involve wholesale distributors, hospital procurement networks, and pharmacy chains. Major pharmaceutical distributors such as McKesson, Cardinal Health, and regional entities facilitate supply chain logistics across different geographies.

For smaller or emerging markets, regional distributors and local wholesalers often source API and finished products from approved manufacturers to meet demand.

Supply Chain Challenges

Supply chain stability faces obstacles like:

• Regulatory changes
• Manufacturing capacity constraints
• Trade restrictions and tariffs
• Quality control issues
• Pandemic-related disruptions

Proactive supplier vetting, maintaining dual sourcing arrangements, and compliance with international standards are best practices to ensure uninterrupted availability of Flagyl.

Key Suppliers Summary

Supplier	Location	Role	Regulatory Status	Notes
Sanofi-Aventis	France	Branded manufacturer	FDA, EMA approved	Original patent holder; high market share
Zhejiang Jiuxian Pharma	China	Generic API & formulations	GMP certified	Focus on cost-effective production
Mitsubishi Tanabe Pharma	Japan	Formulations	Japan PMDA, global approvals	High-quality standards
Apotex Inc.	Canada	Generics	FDA, Health Canada approved	Focus on North American markets
Hunan Jiangsu Pharma	China	API production	GMP, ISO standards	Supplies API globally
Aurobindo Pharma	India	API & formulations	WHO GMP, USFDA approved	Significant global footprint
Torrent Pharmaceuticals	India	API & formulations	WHO GMP	Wide market reach

Conclusion

The supply of Flagyl (metronidazole) hinges on a diversified base of manufacturers, primarily from India, China, and established Western pharmaceutical firms. Ensuring supply chain robustness involves partnering with reputable API producers compliant with international standards and maintaining relationships with authorized distributors.

The dynamic landscape necessitates continuous monitoring of regulatory changes, capacity expansions, and geopolitical factors influencing drug manufacturing and distribution.

---

Key Takeaways

• Major manufacturers of Flagyl include Sanofi, Mitsubishi Tanabe, and Indian generic producers like Aurobindo and Torrent.
• API quality and regulatory compliance are critical for market approvals and supply security.
• The growing generic industry in Asia underpins global availability, often offering cost-effective alternatives.
• Supply chain resilience requires diversified sourcing, vigilant quality oversight, and adherence to international standards.
• Market regulations, geopolitical factors, and pandemic disruptions** remain key considerations for procurement strategies.

---

FAQs

1. What are the primary regions supplying Flagyl globally?
   The predominant regions are India and China for generic APIs and formulations, with Europe and North America hosting major branded manufacturers like Sanofi and MSD.

2. How do regulatory standards influence supplier eligibility?
   Suppliers must comply with GMP standards (WHO, FDA, EMA) to ensure product quality, safety, and efficacy, which is essential for regulatory approval and market access.

3. Are there alternative suppliers for Flagyl if current sources face disruptions?
   Yes, multiple approved manufacturers exist across Asia and the West. Diversifying the supplier base mitigates risks related to supply disruptions.

4. What role do API producers play in the supply chain for Flagyl?
   API producers manufacture the active ingredient essential for formulations. Their quality, capacity, and regulatory compliance directly impact drug availability and safety.

5. How has the COVID-19 pandemic affected Flagyl supply chains?
   The pandemic caused manufacturing delays, logistical disruptions, and increased demand for certain antibiotics, highlighting the importance of supply chain resilience and contingency planning.

---

References

1. [1] WHO Global Benchmarking Tool for pharmaceutical manufacturing.
2. [2] Company websites and FDA filings for manufacturer approvals.
3. [3] Market reports on API and generic drug manufacturing trends.
4. [4] European Medicines Agency (EMA) database.
5. [5] Industry analyses on supply chain risks and dynamics.