Suppliers and packagers for generic pharmaceutical drug: glyburide

glyburide

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532	NDA AUTHORIZED GENERIC	TEVA Pharmaceuticals USA Inc	0093-9364-01	100 TABLET in 1 BOTTLE (0093-9364-01)	1984-05-01
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532	NDA AUTHORIZED GENERIC	TEVA Pharmaceuticals USA Inc	0093-9364-05	500 TABLET in 1 BOTTLE (0093-9364-05)	1984-05-01
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532	NDA AUTHORIZED GENERIC	TEVA Pharmaceuticals USA Inc	0093-9364-10	1000 TABLET in 1 BOTTLE (0093-9364-10)	1984-05-01
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532	NDA AUTHORIZED GENERIC	TEVA Pharmaceuticals USA Inc	0093-9433-01	100 TABLET in 1 BOTTLE (0093-9433-01)	1984-05-01

Glyburide Suppliers: Global Production Landscape and Key Manufacturers

Last updated: February 19, 2026

This analysis details the global supply chain for glyburide, a sulfonylurea oral antidiabetic drug. It identifies key manufacturing regions, dominant suppliers, and regulatory oversight impacting production. The market is characterized by established players and a stable supply of active pharmaceutical ingredients (APIs) and finished dosage forms.

What are the primary active pharmaceutical ingredient (API) suppliers for Glyburide?

The manufacturing of glyburide API is concentrated among a limited number of global producers. These companies adhere to stringent Good Manufacturing Practices (GMP) standards required by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

• India: This nation is a significant hub for API production. Companies like Divi's Laboratories and Laurus Labs are known for their large-scale synthesis capabilities and established regulatory compliance. Divi's Laboratories, for example, is a major global supplier for various APIs, including those in the diabetes therapeutic area. Laurus Labs also holds a strong position in the API market, often supplying to major pharmaceutical formulators.
• China: Chinese manufacturers also contribute substantially to the global glyburide API supply. Companies such as Hubei Gedian Humanwell Pharmaceutical Co., Ltd. and Jiangsu Haosen Pharmaceutical Co., Ltd. are key players. These companies often benefit from competitive manufacturing costs while maintaining the quality standards necessary for regulated markets.
• Europe: While the volume may be lower compared to Asia, some European manufacturers also produce glyburide API. These are typically established fine chemical producers with a long history of pharmaceutical ingredient supply, often serving niche markets or specific customer requirements within the EU.

The market for glyburide API is characterized by mature production processes. The compound's chemical synthesis is well-established, allowing for efficient and cost-effective manufacturing once economies of scale are achieved. Pricing is influenced by raw material costs, production volume, and the competitive landscape among API manufacturers.

Which companies manufacture finished dosage forms (FDFs) of Glyburide?

The production of finished dosage forms (FDFs) for glyburide involves companies that formulate the API into tablets, the most common delivery method. These companies operate under strict regulatory scrutiny to ensure product quality, efficacy, and safety.

• United States: Several major pharmaceutical companies and generic manufacturers produce glyburide tablets in the U.S. Bristol-Myers Squibb was historically a significant developer and marketer of glyburide under the brand name Micronase. Today, generic production is dominated by companies that focus on high-volume oral solid dosage manufacturing. These include Teva Pharmaceuticals, Mylan (now Viatris), and Apotex. These companies have extensive distribution networks and supply to major U.S. retail pharmacies and healthcare providers.
• Europe: Similar to the U.S., European markets feature a mix of originator and generic manufacturers. Companies such as Sanofi (which acquired Bristol-Myers Squibb's European diabetes portfolio in some regions) and Boehringer Ingelheim have been involved in the glyburide market. Generic competition is robust, with firms like Accord Healthcare, Takeda Pharmaceutical Company Limited, and KRKA d.d. supplying glyburide tablets across various European countries.
• India: Indian pharmaceutical companies are not only significant API producers but also major manufacturers of finished dosage forms for both domestic and export markets. Companies like Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories, and Cipla Limited produce glyburide tablets. These companies leverage their cost-effective manufacturing capabilities and strong regulatory track records to compete globally. They often supply to emerging markets and also provide contract manufacturing services.
• Other Regions: Glyburide is also manufactured and distributed in other regions, including Canada, Australia, and various countries in South America and Asia, by local pharmaceutical companies that hold relevant marketing authorizations.

The FDF market is highly competitive, driven by pricing pressures from generic substitution. Manufacturers differentiate themselves through formulation technologies (e.g., micronized versus non-micronized glyburide), packaging, and established market presence.

What is the regulatory landscape for Glyburide manufacturing and supply?

The production and distribution of glyburide are subject to rigorous oversight by national and international regulatory agencies. These regulations ensure the safety, efficacy, and quality of the drug product.

• U.S. Food and Drug Administration (FDA): The FDA regulates glyburide manufacturing through its Current Good Manufacturing Practice (cGMP) regulations. Facilities producing glyburide API and FDFs for the U.S. market must undergo regular inspections. The FDA also reviews Abbreviated New Drug Applications (ANDAs) for generic glyburide products, requiring bioequivalence studies to demonstrate comparability with the reference listed drug. Post-market surveillance includes monitoring for adverse events.
• European Medicines Agency (EMA) and National Competent Authorities: In Europe, the EMA oversees the centralized authorization procedure for some medicines, while national competent authorities (e.g., the MHRA in the UK, BfArM in Germany) manage approvals within their respective member states. Manufacturers must comply with EU GMP guidelines. The EMA and national agencies conduct inspections of manufacturing sites.
• Other Regulatory Bodies: Similar regulatory frameworks exist in other major markets, including Health Canada, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and the Therapeutic Goods Administration (TGA) in Australia. These agencies enforce GMP standards and require rigorous documentation for product approval.
• International Harmonization: Efforts towards international harmonization of pharmaceutical regulations, such as through the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), aim to standardize requirements for API and FDF manufacturing, facilitating global trade and ensuring consistent quality.
• Patent Expirations and Generic Entry: The patent landscape for glyburide has long since expired in most major markets. This has led to a highly competitive generic market, influencing pricing and supply dynamics. Manufacturers must navigate intellectual property rights related to specific formulations or manufacturing processes, although the core compound itself is off-patent.

Regulatory compliance is a significant barrier to entry for new manufacturers. Maintaining compliance requires substantial investment in quality control systems, personnel training, and facility upgrades. Any lapse in compliance can result in import alerts, product recalls, or suspension of manufacturing operations, impacting the global supply chain.

What are the key therapeutic indications and market dynamics for Glyburide?

Glyburide (also known as glibenclamide) is a first-generation sulfonylurea medication used to manage type 2 diabetes mellitus. Its primary mechanism of action is to stimulate insulin secretion from pancreatic beta cells.

• Primary Indication: Glyburide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is often used when other lifestyle modifications and oral antidiabetic agents have not achieved adequate blood glucose levels.
• Market Position: Glyburide is a well-established and widely prescribed medication. Its long history of use means its safety profile and efficacy are extensively documented. However, it is considered a first-generation sulfonylurea, and newer generations of sulfonylureas and other classes of antidiabetic drugs (e.g., DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) offer improved efficacy, lower risk of hypoglycemia, and additional cardiovascular or renal benefits.
• Market Dynamics:
  • Generic Dominance: Due to patent expirations, the glyburide market is overwhelmingly dominated by generic manufacturers. This results in significant price competition, making it one of the more affordable options for diabetes management.
  • Declining Market Share (in some developed countries): In developed markets like the U.S. and Europe, glyburide's market share has been gradually declining as physicians increasingly opt for newer classes of antidiabetic medications that offer better safety profiles, particularly regarding hypoglycemia, and additional benefits.
  • Continued Use in Emerging Markets: Glyburide remains an important and widely used drug in many emerging markets due to its low cost and established availability. Its affordability makes it a critical treatment option for populations with limited access to more expensive newer medications.
  • Combination Therapies: Glyburide is also available in fixed-dose combination products with other antidiabetic agents, such as metformin (e.g., glyburide-metformin). This offers convenience for patients requiring multiple medications.
  • Competition: The competitive landscape for glyburide FDFs is intense, with numerous manufacturers offering the drug. Competition primarily centers on price, product availability, and relationships with distributors and pharmacy benefit managers.

The long-term market trajectory for glyburide in developed countries is likely to see continued erosion as newer agents gain favor. However, its role as a cost-effective treatment option will ensure its sustained relevance in global diabetes management, particularly in regions with cost constraints.

What are the quality control and analytical standards for Glyburide?

Ensuring the quality of glyburide API and FDFs is paramount and involves rigorous analytical testing against established pharmacopoeial standards.

• Pharmacopoeial Standards: The primary quality benchmarks for glyburide are defined by major pharmacopoeias, including:
  • United States Pharmacopeia (USP): The USP monograph for Glyburide (or Glibenclamide) specifies tests for identification, assay (potency), related substances (impurities), residual solvents, water content, and heavy metals. It defines acceptance criteria for each test. For FDFs, disintegration, dissolution, and uniformity of dosage units are critical.
  • European Pharmacopoeia (Ph. Eur.): The Ph. Eur. provides similar specifications for Glibenclamide, covering chemical purity, physical characteristics, and analytical methods.
  • British Pharmacopoeia (BP) and Japanese Pharmacopoeia (JP): These pharmacopoeias also have specific monographs for glyburide, generally aligning with USP and Ph. Eur. standards.
• Analytical Methods: Standard analytical techniques employed include:
  • High-Performance Liquid Chromatography (HPLC): This is the primary method for assaying glyburide content and quantifying related substances, which include process impurities, degradation products, and other potential contaminants. Specific HPLC methods are validated to ensure sensitivity, specificity, and accuracy.
  • Spectrophotometry (UV/Vis): Used for identification and sometimes for quantitative analysis, relying on glyburide's characteristic absorbance spectrum.
  • Gas Chromatography (GC): Employed to determine residual solvents in the API, ensuring they are below acceptable limits as defined by ICH guidelines.
  • Karl Fischer Titration: Used to measure water content in the API.
  • Dissolution Testing: For FDFs, dissolution tests measure the rate and extent to which glyburide dissolves from the tablet under specified conditions, which is critical for predicting in vivo absorption and bioavailability.
  • Disintegration Testing: For tablets, this test ensures the dosage form breaks apart within a specified time frame, facilitating dissolution.
• Impurity Profiling: Identifying and controlling impurities is a critical aspect of quality control. Regulatory agencies require manufacturers to characterize and limit known impurities and to establish thresholds for unknown impurities. Common impurities may include starting materials, intermediates, or degradation products formed during synthesis or storage.
• Stability Studies: Manufacturers conduct extensive stability studies on both API and FDFs to determine shelf life and appropriate storage conditions. These studies involve exposing the drug product to various temperature, humidity, and light conditions over time and analyzing for changes in potency, purity, and physical characteristics.

Compliance with these pharmacopoeial standards and rigorous analytical testing ensures that each batch of glyburide API and FDF meets the required quality attributes for patient safety and therapeutic efficacy.

Key Takeaways

• Glyburide API manufacturing is primarily concentrated in India and China, with significant contributions from established global players.
• Finished dosage form (FDF) production is widespread, led by generic manufacturers in the U.S., Europe, and India, catering to both developed and emerging markets.
• The regulatory landscape is robust, with the FDA and EMA enforcing stringent GMP standards and requiring comprehensive data for product approval.
• Glyburide remains a cost-effective treatment for type 2 diabetes, particularly in emerging markets, though its market share in developed countries is declining due to the availability of newer antidiabetic agents.
• Quality control relies heavily on pharmacopoeial standards (USP, Ph. Eur.) and validated analytical methods, primarily HPLC, to ensure API and FDF potency, purity, and stability.

Frequently Asked Questions

1. Who are the major generic manufacturers of glyburide tablets in the U.S. market? Teva Pharmaceuticals, Viatris (formerly Mylan), and Apotex are significant generic manufacturers supplying glyburide tablets in the U.S.

2. What is the typical shelf life for glyburide tablets? The typical shelf life for glyburide tablets is generally between two to three years, as determined by stability studies and approved by regulatory agencies.

3. Are there any specific handling or storage requirements for glyburide API? Glyburide API should be stored in well-closed containers, protected from light, and at controlled room temperature to maintain its stability and prevent degradation.

4. What are the main impurities that manufacturers must monitor in glyburide production? Manufacturers must monitor process impurities from synthesis, such as unreacted starting materials or intermediates, and potential degradation products formed during storage. Specific impurity limits are defined in pharmacopoeial monographs.

5. Can glyburide be used in combination with other diabetes medications? Yes, glyburide is frequently used in fixed-dose combination tablets with metformin and can also be prescribed in conjunction with other classes of antidiabetic agents, under physician supervision.

Citations

[1] United States Pharmacopeia. (n.d.). Glyburide. USP-NF. [2] European Pharmacopoeia. (n.d.). Glibenclamide. Ph. Eur. [3] U.S. Food and Drug Administration. (n.d.). Guidance Documents & Regulatory Information. FDA.gov. [4] European Medicines Agency. (n.d.). Medicine Approvals. EMA.europa.eu. [5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guideline Documents. ICH.org. [6] Divi's Laboratories. (n.d.). Product Portfolio. Divis.com. [7] Laurus Labs. (n.d.). APIs. LaurusLabs.com. [8] Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (n.d.). Product Information. (Company-specific information, often accessed via industry databases or company websites). [9] Jiangsu Haosen Pharmaceutical Co., Ltd. (n.d.). Product Catalog. (Company-specific information). [10] Teva Pharmaceuticals. (n.d.). Product Information. Teva.com. [11] Viatris Inc. (n.d.). Our Products. Viatris.com. [12] Apotex Inc. (n.d.). Product Catalogue. Apotex.com. [13] Sun Pharmaceutical Industries Ltd. (n.d.). Product Pipeline. SunPharma.com. [14] Dr. Reddy's Laboratories. (n.d.). Global Markets & Products. DrReddys.com. [15] Cipla Limited. (n.d.). Therapeutic Areas. Cipla.com.