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Last Updated: March 26, 2026

Suppliers and packagers for generic pharmaceutical drug: GLIMEPIRIDE


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GLIMEPIRIDE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Accord Hlthcare GLIMEPIRIDE glimepiride TABLET;ORAL 078181 ANDA Accord Healthcare Inc 16729-001-01 100 TABLET in 1 BOTTLE (16729-001-01) 2007-08-23
Accord Hlthcare GLIMEPIRIDE glimepiride TABLET;ORAL 078181 ANDA Accord Healthcare Inc 16729-001-16 500 TABLET in 1 BOTTLE (16729-001-16) 2007-08-23
Accord Hlthcare GLIMEPIRIDE glimepiride TABLET;ORAL 078181 ANDA Accord Healthcare Inc 16729-002-01 100 TABLET in 1 BOTTLE (16729-002-01) 2007-08-23
Accord Hlthcare GLIMEPIRIDE glimepiride TABLET;ORAL 078181 ANDA Accord Healthcare Inc 16729-002-16 500 TABLET in 1 BOTTLE (16729-002-16) 2007-08-23
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Glimepiride

Last updated: February 20, 2026

Multiple pharmaceutical companies manufacture glimepiride, a second-generation sulfonylurea used to treat type 2 diabetes. The drug is widely available through both brand-name and generic manufacturers.

Top Global Manufacturers

Manufacturer Country Scale of Production Key Brands
Sanofi France Global Amaryl (brand-name), generic formulations
Accord Healthcare India Extensive Generic glimepiride
Lupin Limited India Large-scale Generic formulations
Sun Pharmaceutical Industries India Major producer Generic formulations
Mylan (now part of Viatris) USA Global Generic glimepiride
Aurobindo Pharma India Substantial Generic formulations
Cipla India Major supplier Generic formulations
Teva Pharmaceutical Industries Israel Large-scale Generic glimepiride

Key Points

  • Generics dominate the market, accounting for approximately 90% of global glimepiride supply.
  • Brand name formulations like Sanofi's Amaryl are commercially available but represent a smaller share of total production.
  • India and Israel are leading regions for manufacturing, with India supplying the majority of generic formulations due to lower production costs.
  • Other regional suppliers include companies in China, Egypt, and Eastern Europe, which produce both branded and generic versions.

Market Dynamics

  • Regulatory approval processes in different countries impact supplier availability.
  • The drug is included on the World Health Organization's Essential Medicines List, prompting widespread procurement by government health systems.
  • Patent status: Patent protections have expired in most jurisdictions, facilitating a broad base of generic manufacturers.

Supply Chain Considerations

  • The reliance on a primarily generic manufacturing base introduces variability in supply chain stability.
  • Recently, some suppliers faced shortages due to regulatory delays, quality issues, or export restrictions.
  • Quality assurance and compliance with regulatory standards (e.g., FDA, EMA, CDSCO) are critical for global distribution.

Conclusion

Leading suppliers of glimepiride include Sanofi (Amaryl), and numerous Indian manufacturers such as Accord Healthcare, Lupin, Aurobindo Pharma, and Cipla. Market dominates by generics reflects low barriers to entry and patent expirations, making the drug widely available worldwide.

Key Takeaways

  • The global glimepiride market is dominated by generic manufacturers, with Indian firms forming the core of production.
  • Sanofi remains a key brand-name supplier with Amaryl.
  • Supply chain stability depends heavily on quality compliance and regulatory approvals.
  • Market entries are driven by patent expirations and local regulatory conditions.
  • The drug’s classification as an essential medicine supports widespread procurement and supply.

FAQs

1. Who are the largest producers of generic glimepiride?
Indian companies such as Accord Healthcare, Lupin, Aurobindo Pharma, and Cipla are the largest producers.

2. Is glimepiride available as a brand-name or only generics?
It is available both as a brand-name (e.g., Amaryl) and as numerous generics.

3. How does regional regulation impact supplier availability?
Regulatory approval delays can restrict or delay supply, especially in markets with stringent drug registration processes.

4. Are there concerns about quality among generic suppliers?
Variability exists; suppliers adhering to international standards like FDA or EMA are generally considered reliable.

5. What regions lead global manufacturing of glimepiride?
India leads in generic production, followed by Israel, China, and other regions with active pharmaceutical manufacturing sectors.


References

  1. World Health Organization. (2021). Essential medicines. Retrieved from https://www.who.int/groups/expert-committee-on-selection-and-use-of-essential-medicines/essential-medicines-list
  2. IMS Health. (2022). Global pharmaceutical market analysis.
  3. U.S. Food and Drug Administration. (2022). Drug approvals and manufacturing standards.
  4. Indian Pharmaceutical Market. (2022). Industry reports on generics and major players.
  5. European Medicines Agency. (2022). Regulatory approvals for generic medicines.

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