Suppliers and packagers for generic pharmaceutical drug: azilsartan kamedoxomil; chlorthalidone

azilsartan kamedoxomil; chlorthalidone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	60631-412-30	30 TABLET in 1 BOTTLE (60631-412-30)	2013-02-01
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	60631-425-30	30 TABLET in 1 BOTTLE (60631-425-30)	2013-02-01
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Pharma Packaging Solutions, LLC dba Tjoapack LLC	75929-230-03	30 TABLET in 1 BOTTLE (75929-230-03)	2013-02-01

AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE: KEY GLOBAL SUPPLIER LANDSCAPE

Last updated: February 19, 2026

This analysis details the key global suppliers of Azilsartan Medoxomil and Chlorthalidone, active pharmaceutical ingredients (APIs) critical for hypertension treatment. The report identifies primary manufacturers, their geographic distribution, and relevant patent and regulatory considerations impacting supply chain dynamics.

Who are the Major API Manufacturers for Azilsartan Medoxomil?

The global manufacturing landscape for Azilsartan Medoxomil API is concentrated among a limited number of entities, primarily located in Asia. These manufacturers are crucial for both branded and generic drug production.

• Takeda Pharmaceutical Company: As the innovator of Azilsartan Medoxomil (marketed as Edarbi®), Takeda maintains significant control over its API production, particularly during the patent-protected period. The primary manufacturing sites for Takeda's API are located in Japan.
• Major API Suppliers in India: India is a significant hub for generic API manufacturing. Several Indian companies have developed capabilities to produce Azilsartan Medoxomil API, often targeting post-patent expiration markets or supplying to generic drug formulators globally. Key players include:
  • Dr. Reddy's Laboratories: A prominent Indian pharmaceutical company with a strong API manufacturing base.
  • Sun Pharmaceutical Industries Ltd.: Another leading Indian pharmaceutical firm with extensive API production facilities.
  • Laurus Labs Limited: A research-driven pharmaceutical company that has established a presence in complex API manufacturing.
• Chinese API Manufacturers: China is another major global supplier of APIs. While specific publicly disclosed Azilsartan Medoxomil API manufacturing by large Chinese chemical and pharmaceutical conglomerates is less prominent than in India, many smaller and mid-sized Chinese chemical manufacturers are capable of producing this API. These entities often supply intermediates or custom synthesis services.
• Key Intermediate Suppliers: The synthesis of Azilsartan Medoxomil involves several key intermediates. Companies specializing in the production of these intermediates, such as specific substituted benzimidazoles and triazole derivatives, play a vital role in the supply chain. Identifying these upstream suppliers is critical for supply chain resilience.

Table 1: Key Manufacturers and Geographic Distribution of Azilsartan Medoxomil API

Manufacturer	Country of Origin	Primary Focus
Takeda Pharmaceutical Company	Japan	Branded drug API, internal supply
Dr. Reddy's Laboratories	India	Generic API, custom synthesis
Sun Pharmaceutical Industries	India	Generic API, broad pharmaceutical ingredient portfolio
Laurus Labs Limited	India	Generic API, focus on complex chemistry
Various Chinese Manufacturers	China	Intermediates, custom synthesis, emerging API supply

What is the Supply Landscape for Chlorthalidone API?

Chlorthalidone, a thiazide-like diuretic, has a more established and fragmented API supply market compared to Azilsartan Medoxomil due to its longer history of use and broader application in combination therapies.

• Established Generic Manufacturers in India: India is the dominant global producer of Chlorthalidone API. Numerous Indian pharmaceutical companies manufacture this API to meet the demands of generic drug manufacturers worldwide. These companies benefit from cost efficiencies and extensive regulatory compliance infrastructure.
  • Aarti Industries Limited: A significant player in the Indian chemical and pharmaceutical sector, known for its backward integration and production of various APIs, including diuretics.
  • Lasa Supergenerics Limited: Specializes in the development and manufacturing of APIs.
  • Divi's Laboratories: While known for its expertise in custom synthesis and large-scale production of various APIs, Divi's is a potential supplier for widely used generics like Chlorthalidone.
• Chinese Manufacturers: Chinese manufacturers also contribute significantly to the global supply of Chlorthalidone API. They often offer competitive pricing and have the capacity for large-scale production.
  • Jiangsu Hande Bio-Tech Co., Ltd.: A Chinese company that is a known producer of various APIs.
  • Zhejiang Huahai Pharmaceutical Co., Ltd.: A major pharmaceutical company in China with substantial API manufacturing capabilities.
• European Manufacturers: While the bulk of Chlorthalidone API production is in Asia, some European manufacturers may exist, potentially focusing on higher purity grades or specialized markets. However, their market share is generally smaller.
• US-Based Manufacturers: The US has limited large-scale API manufacturing for commodity generics like Chlorthalidone, with most supply sourced internationally.

Table 2: Key Manufacturers and Geographic Distribution of Chlorthalidone API

Manufacturer	Country of Origin	Primary Focus
Aarti Industries Limited	India	Broad API portfolio, Chlorthalidone
Lasa Supergenerics Limited	India	Generic API manufacturer
Divi's Laboratories	India	Custom synthesis, large-scale API
Jiangsu Hande Bio-Tech Co., Ltd.	China	API production, diverse chemical products
Zhejiang Huahai Pharmaceutical	China	Major API producer

What are the Patent and Regulatory Considerations?

Patent status and regulatory approvals are critical determinants of market access and supplier selection for both Azilsartan Medoxomil and Chlorthalidone.

Azilsartan Medoxomil Patent Landscape

• US Patent Expiration: The primary patents protecting Azilsartan Medoxomil (Edarbi®) in the United States have largely expired or are nearing expiration, opening the door for generic competition. For instance, U.S. Patent No. 7,405,202, a key patent for the compound, expired in 2023. Generic manufacturers have actively pursued Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA).
• European Patent Expirations: Similar patent expiries are observed across major European markets, enabling the entry of generic versions of Azilsartan Medoxomil.
• Regulatory Filings: API manufacturers seeking to supply generic drug producers must have their manufacturing facilities and processes approved by regulatory bodies such as the FDA, European Medicines Agency (EMA), and others. This involves filing Drug Master Files (DMFs) or Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs).
• Litigation: The patent landscape for Azilsartan Medoxomil has involved significant patent litigation, particularly concerning new crystalline forms and formulations. Generic API suppliers must navigate this complex legal environment to ensure freedom to operate.

Chlorthalidone Patent and Regulatory Landscape

• Generically Available: Chlorthalidone is a well-established generic drug. Its original compound patents expired decades ago. The focus is on ensuring API quality, manufacturing consistency, and compliance with current Good Manufacturing Practices (cGMP).
• Pharmacopoeial Standards: API manufacturers must comply with established pharmacopoeial standards, such as those outlined in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). These monographs define the identity, purity, and quality requirements for Chlorthalidone API.
• ANDA and DMF Submissions: API suppliers for the US market typically submit DMFs to the FDA. For European markets, CEPs are crucial. These filings provide regulatory agencies with detailed information about the API manufacturing process, controls, and specifications.
• Quality Control: Regulatory bodies place a strong emphasis on the quality control and analytical testing of generic APIs. Any deviations from established specifications or cGMP violations can lead to import alerts and supply disruptions.

Table 3: Key Regulatory Considerations for API Supply

API	Primary Patent Status Impact	Key Regulatory Filings	Major Regulatory Agencies
Azilsartan Medoxomil	Post-patent or nearing	DMF, CEP	FDA, EMA
Chlorthalidone	Long expired	DMF, CEP	FDA, EMA, JPMA

What are the Supply Chain Risks and Mitigation Strategies?

The supply chain for both Azilsartan Medoxomil and Chlorthalidone APIs faces several risks, including geopolitical instability, regulatory changes, quality control issues, and single-source dependencies.

• Geopolitical Risks: The concentration of manufacturing in specific regions, particularly India and China, exposes the supply chain to geopolitical tensions, trade disputes, or local regulatory crackdowns. For example, environmental regulations in China have, at times, led to temporary shutdowns of chemical manufacturing facilities.
• Quality Control and Compliance: The risk of API contamination or non-compliance with cGMP is a constant concern. The FDA's inspection of overseas manufacturing sites and subsequent import alerts can severely disrupt supply. The recall of Valsartan API in 2018 due to nitrosamine impurities serves as a stark reminder of potential quality issues affecting similar Angiotensin II Receptor Blockers (ARBs).
• Price Volatility: Fluctuations in raw material costs, energy prices, and currency exchange rates can impact API pricing. Competition among generic API suppliers also influences cost dynamics.
• Single-Source Dependency: Over-reliance on a single API manufacturer or a limited number of suppliers for a critical ingredient creates significant vulnerability. If that supplier experiences production issues, regulatory sanctions, or financial distress, it can halt drug manufacturing.

Mitigation Strategies:

• Supplier Diversification: Establishing relationships with multiple qualified API suppliers across different geographic regions is paramount. This strategy reduces dependence on any single entity and provides flexibility in case of disruptions.
• Auditing and Qualification: Rigorous, ongoing auditing of API manufacturers' facilities, quality systems, and regulatory compliance is essential. This includes on-site inspections and review of batch records and analytical data.
• Dual Sourcing and Inventory Management: For critical APIs, implementing dual sourcing strategies where feasible and maintaining strategic inventory levels of both API and key intermediates can buffer against unforeseen supply interruptions.
• Backward Integration: For large pharmaceutical companies, investing in or securing robust supply chains for key starting materials and intermediates can enhance control and reduce external dependencies.
• Regulatory Intelligence: Proactive monitoring of regulatory changes in key manufacturing regions and target markets is crucial to anticipate and adapt to evolving compliance requirements.

Key Takeaways

• Azilsartan Medoxomil API manufacturing is primarily concentrated among Takeda (originator), with growing generic supply from Indian and emerging Chinese manufacturers.
• Chlorthalidone API production is dominated by a larger, more established base of generic manufacturers in India and China.
• Patent expirations are a key driver for generic Azilsartan Medoxomil API supply, while Chlorthalidone is a mature generic with established supply chains.
• Regulatory compliance, specifically cGMP adherence and successful DMF/CEP filings, is critical for all API suppliers.
• Supply chain risks include geopolitical factors, quality control failures, and single-source dependencies, necessitating robust mitigation strategies such as supplier diversification and rigorous auditing.

Frequently Asked Questions

1. Which companies are the primary innovators of Azilsartan Medoxomil and what is their current API supply role? Takeda Pharmaceutical Company is the innovator of Azilsartan Medoxomil. While they maintain internal API production capabilities for their branded product, their role in supplying the generic API market is limited.
2. What are the main regulatory hurdles for new Azilsartan Medoxomil API suppliers entering the market? New suppliers must obtain regulatory approval for their manufacturing facilities and processes from agencies like the FDA and EMA. This involves successfully filing Drug Master Files (DMFs) or Certificates of Suitability (CEPs), demonstrating compliance with current Good Manufacturing Practices (cGMP), and successfully navigating any ongoing patent litigation.
3. How significant is the price difference between Azilsartan Medoxomil API and Chlorthalidone API? Azilsartan Medoxomil API is generally more expensive due to its more complex synthesis, relatively newer patent status, and lower production volumes compared to the long-established, high-volume Chlorthalidone API.
4. Are there any known quality issues or recalls associated with Chlorthalidone API from major suppliers? While Chlorthalidone is a mature API, like any pharmaceutical ingredient, instances of quality deviations or recalls can occur. Manufacturers must adhere strictly to pharmacopoeial standards and cGMP. The industry is sensitive to past recalls of unrelated APIs (e.g., Valsartan) that highlight the critical importance of impurity control.
5. What is the impact of China's environmental regulations on the supply of Chlorthalidone API? Stricter environmental regulations in China can lead to temporary production suspensions for chemical and API manufacturers to comply with new standards. This can create short-term supply constraints and price increases for affected APIs, including Chlorthalidone, if Chinese manufacturers constitute a significant portion of the global supply.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations [2] European Medicines Agency. (n.d.). Register of medicinal products. Retrieved from https://www.ema.europa.eu/en/medicines/register-medicinal-products [3] Takeda Pharmaceutical Company Limited. (n.d.). Investor Relations. Retrieved from https://www.takeda.com/investors/ [4] Dr. Reddy's Laboratories. (n.d.). API Business. Retrieved from https://www.drreddys.com/businesses/api-business/ [5] Sun Pharmaceutical Industries Ltd. (n.d.). API. Retrieved from https://www.sunpharma.com/our-businesses/api [6] Laurus Labs Limited. (n.d.). APIs. Retrieved from https://www.lauruslabs.com/apis/ [7] Aarti Industries Limited. (n.d.). Speciality Chemicals and Pharmaceuticals. Retrieved from https://www.aarti-industries.com/ [8] Divi's Laboratories. (n.d.). Products. Retrieved from https://www.divislabs.com/products [9] Zhejiang Huahai Pharmaceutical Co., Ltd. (n.d.). API. Retrieved from https://www.huahaipharm.com/en/API.html