Suppliers and packagers for micardis

micardis

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0040-37	3 BLISTER PACK in 1 CARTON (0597-0040-37) / 10 TABLET in 1 BLISTER PACK	2000-12-01
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0041-37	3 BLISTER PACK in 1 CARTON (0597-0041-37) / 10 TABLET in 1 BLISTER PACK	2000-12-01

Suppliers for the Pharmaceutical Drug: MICARDIS

Last updated: July 28, 2025

Introduction

MICARDIS (telmisartan) is a widely prescribed antihypertensive medication developed by Boehringer Ingelheim. As an angiotensin II receptor blocker (ARB), it is used primarily to treat hypertension and reduce cardiovascular risk. The global demand for MICARDIS has prompted inquiries into its supply chain, including key manufacturers, contract manufacturing organizations (CMOs), and raw material suppliers. Understanding the landscape of MICARDIS suppliers is essential for stakeholders in the pharmaceutical industry, including investors, healthcare providers, and supply chain managers, to ensure drug availability, manage risks, and optimize procurement strategies.

Manufacturers of MICARDIS

Original Innovator Supplier

Boehringer Ingelheim
As the original patent holder and producer, Boehringer Ingelheim maintains control of MICARDIS’s formulation and branding. The company operates multiple manufacturing facilities globally, primarily in Germany and the United States, which produce the active pharmaceutical ingredient (API) and finished dosage forms. Despite patent expiration in certain markets, Boehringer Ingelheim continues to manufacture MICARDIS for regions where patent protections remain or under exclusive licensing agreements, maintaining a significant share of supply.

Generic Manufacturers

Following patent expiration, multiple generic pharmaceutical companies now manufacture telmisartan, increasing the drug’s global availability and affordability. Notable generic suppliers include:

• Mylan (now Viatris): A leading global manufacturer of generic ARBs, including telmisartan, with manufacturing sites across India, Europe, and the US.
• Teva Pharmaceuticals: A major player in generic pharmaceuticals with manufacturing facilities in Israel, India, and the US. Teva produces telmisartan for various markets.
• Sun Pharmaceutical Industries: An Indian pharmaceutical company, Sun Pharma manufactures telmisartan API and finished formulations for global distribution.
• Hetero Labs: Based in India, Hetero supplies the generic telmisartan API and finished dosages across multiple markets.
• Lupin Limited: Also based in India, Lupin produces telmisartan APIs and formulations providing competitive alternatives.

Other regional generics manufacturers, particularly in India and China, supply telmisartan APIs and finished drugs to both domestic and international markets, withFDA and EMA approvals varying by manufacturer.

Raw Material (API) Suppliers

The supply chain for MICARDIS critically depends on the availability of high-quality telmisartan APIs. Leading API producers include:

• Mitsubishi Tanabe Pharma Corporation: Japanese company also involved in API synthesis for telmisartan, often supplying originator formulations.
• Hikal Ltd.: Indian API manufacturer, producing telmisartan API for various clients.
• Cadila Healthcare: An Indian pharmaceutical company with API manufacturing capabilities, including telmisartan.
• WuXi AppTec: A global CRO and CDMO with capability in APIs, providing telmisartan synthesis services chosen by several generics companies.

API quality and supply stability are often verified through regulatory approvals such as FDA, EMA, or PMDA certifications, which influence procurement decisions.

Contract Manufacturing Organizations (CMOs)

Several pharma contract manufacturers produce finished dosage forms of MICARDIS or manufacture APIs for generic versions:

• Dr. Reddy’s Laboratories: Offers contract manufacturing for telmisartan formulations and APIs, ensuring capacity for surges in demand.
• Aurobindo Pharma: A key CMO for telmisartan drugs, with facilities approved by various regulatory agencies.
• Zhejiang Huahai Pharmaceutical: Chinesemanufacturer with APIs approved by global agencies, supplying generics worldwide.
• Taj Pharma: Indian CMO manufacturing telmisartan tablets for multiple clients.

These organizations operate under strict regulatory compliance to ensure consistent quality and supply reliability.

Supply Chain Dynamics and Market Trends

The MICARDIS supply chain has experienced shifts:

• Patent Expiry and Generics Surge: Since patent expiration in numerous jurisdictions, the market has expanded with multiple generics, leading to increased manufacturing capacity and price competition.
• Regional Variability: Asia, especially India and China, dominates API production due to cost advantages and regulatory frameworks.
• Supply Disruptions: COVID-19 and geopolitical tensions impacting China and India have occasionally disrupted API availability, prompting manufacturers to diversify suppliers and increase inventory buffers.
• Regulatory Changes: Stringent quality standards and approvals influence supplier selection and market access.

Future Outlook and Supplier Strategies

Supply chain security for MICARDIS involves diversification of API sources, fostering relationships with multiple approved manufacturers, and maintaining strategic stockpiles. Continuous monitoring of regulatory updates and geopolitical developments remains crucial. As biosimilar and alternative ARB options emerge, the demand dynamics for telmisartan products may evolve, impacting supplier priorities and investments.

Key Takeaways

• The primary producer of MICARDIS was Boehringer Ingelheim; however, generic manufacturers now dominate global supply.
• Top API suppliers include Mitsubishi Tanabe Pharma, Hikal, Cadila Healthcare, and WuXi AppTec, with regional strengths in India and China.
• Contract manufacturing organizations like Dr. Reddy’s and Aurobindo provide finished formulations, ensuring capacity for market expansion.
• Supply chain risks from geopolitical and pandemic-related disruptions underscore the importance of diversified sourcing strategies.
• Regulatory compliance and quality assurance are paramount in selecting API and formulation suppliers for MICARDIS.

FAQs

1. Who are the main suppliers of MICARDIS in the global market?
The most prominent suppliers include Boehringer Ingelheim (original manufacturer) and numerous generics producers such as Mylan (Viatris), Teva, Sun Pharma, Hetero, and Lupin, with API manufacturing primarily in India, China, and Japan.

2. How has patent expiration affected MICARDIS supply?
Patent expiration has led to an influx of generic manufacturers, increasing production capacity, reducing prices, and improving global accessibility, especially in price-sensitive markets.

3. What are the key factors in selecting MICARDIS API suppliers?
Regulatory approval status, API quality and purity, manufacturing capacity, supply reliability, and adherence to Good Manufacturing Practices (GMP) are critical considerations.

4. How do geopolitical tensions impact MICARDIS supply chain security?
Disruptions in China and India due to trade tensions, COVID-19, or regulation changes can impact API availability, prompting companies to diversify suppliers and build strategic inventories.

5. What is the outlook for MICARDIS supply chain resilience?
Increasing diversification of suppliers, regional manufacturing expansion, and enhanced regulatory oversight aimed at quality assurance will bolster resilience against future disruptions.

---

Sources:
[1] Boehringer Ingelheim official website and product data sheets.
[2] IMS Health (IQVIA) global pharmaceutical market reports.
[3] Global pharma API manufacturing access reports.
[4] US FDA Drug Master File (DMF) listings for telmisartan APIs.
[5] Industry analysis reports on generic ARB markets.