cialis: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368	NDA	Eli Lilly and Company	0002-4462-30	30 TABLET, FILM COATED in 1 BOTTLE (0002-4462-30)	2003-11-26
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368	NDA	Eli Lilly and Company	0002-4463-30	30 TABLET, FILM COATED in 1 BOTTLE (0002-4463-30)	2003-11-26
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368	NDA	Eli Lilly and Company	0002-4464-30	30 TABLET, FILM COATED in 1 BOTTLE (0002-4464-30)	2003-11-26
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368	NDA	Eli Lilly and Company	0002-4465-34	2 BLISTER PACK in 1 CARTON (0002-4465-34) / 15 TABLET, FILM COATED in 1 BLISTER PACK (0002-4465-79)	2008-01-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Cialis (tadalafil) is a widely prescribed phosphodiesterase type 5 (PDE5) inhibitor primarily used for the treatment of erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). Since its approval by the U.S. Food and Drug Administration (FDA) in 2003, Cialis has become a staple in the global pharmaceutical landscape. The drug’s manufacturing and distribution involve a complex network of licensed manufacturers, generic producers, and authorized suppliers spanning multiple regions. Understanding these suppliers provides critical insights into the drug’s market dynamics, supply chain resilience, and regulatory landscape.

Major Patent Holders and Original Manufacturer

Eli Lilly and Company, an American pharmaceutical giant, originally developed and marketed Cialis. The drug was launched globally in the early 2000s under Lilly's brand name. Lilly maintained exclusive rights to the patent until it expired in many jurisdictions, opening the market to generic manufacturers. The company's role extended to establishing manufacturing agreements, quality controls, and supply chain infrastructure to ensure consistent distribution.

Generic Manufacturers Post-Patent Expiry

Following patent expiration, multiple generic pharmaceutical companies began producing tadalafil, the active pharmaceutical ingredient (API) in Cialis. These manufacturers are pivotal in diversifying supply sources and reducing treatment costs.

Leading Generic Suppliers

Mylan (now part of Viatris): One of the early entrants into the generic tadalafil market, Mylan obtained FDA approval shortly after patent expiry, establishing a significant supply chain.
Teva Pharmaceuticals: Based in Israel, Teva is among the largest generic drug producers globally, offering tadalafil generics approved across various markets, including North America, Europe, and Asia.
Lupin Limited: An Indian pharmaceutical company, Lupin produces tadalafil tablets distributed across Asia, Africa, and emerging markets.
Sun Pharmaceutical Industries: Also based in India, Sun Pharma supplies tadalafil generics to global markets, often at competitive prices.
Aurobindo Pharma: Indian innovator in generic APIs, Aurobindo manufactures tadalafil for international markets, especially in Latin America and Africa.
Cipla: Another major Indian generic manufacturer, Cipla supplies tadalafil across multiple regions, including Africa and South Asia.

Emerging and Regional Suppliers

Regional pharmaceutical firms in China, Argentina, and Southeast Asia have also entered the tadalafil market, often producing lower-cost generics and expanding access, especially in developing countries.

Suppliers of Active Pharmaceutical Ingredient (API)

The manufacturing of tadalafil begins with sourcing high-quality APIs. Several key API producers operate globally, with India and China dominating this sector.

Jiangsu Hengrui Medicine Co., Ltd. (China): A leading Chinese pharmaceutical firm supplying tadalafil API for global markets.
Taj Pharmaceuticals (India): Supplies high-quality tadalafil API for both proprietary and generic formulations.
Zhejiang Huahai Pharmaceutical (China): Produces a broad portfolio of APIs, including tadalafil, with export commitments worldwide.
Aurobindo Pharma (India): Apart from finished dosage forms, Aurobindo manufactures API for global export.
Hikal Ltd.: An India-based manufacturer specializing in APIs and intermediates for erectile dysfunction drugs.

The API sourcing landscape is characterized by rigorous quality standards, especially as regulatory authorities continue to enforce Good Manufacturing Practices (GMP).

Authorized and Contract Manufacturing

Many pharmaceutical companies rely on contract manufacturing organizations (CMOs) for producing tadalafil tablets or API. This strategic outsourcing aids in capacity expansion and regulatory compliance. Notable CMOs include:

Patheon (a Thermo Fisher Scientific company)
Lonza Group
Alcami
Aenova Group

These organizations typically manufacture API or finished doses under strict GMP conditions, with some licensed by original patent holders or regional agencies.

Regulatory and Quality Considerations

Suppliers for Cialis, especially generics, must adhere to stringent regulatory standards set by agencies such as the FDA (U.S.), EMA (Europe), and PMDA (Japan). Regulatory approval often depends on facilities’ compliance with GMP, validated manufacturing processes, and stable supply lines.

In some cases, supply chain disruptions—such as those experienced during the COVID-19 pandemic—have highlighted the vulnerability of reliance on certain suppliers, emphasizing the importance of diversified sourcing strategies.

Market Dynamics and Supply Chain Challenges

The Cialis supply chain exhibits several key trends:

Transition from Patent to Generics: As patents expired in different regions (e.g., in the US in 2017), the market experienced increased competition, leading to multiple suppliers entering the space.
Price Competition: The proliferation of generic tadalafil suppliers has driven prices down, making the drug more accessible and increasing demand in emerging markets.
Supply Chain Risks: Concentration of API manufacturing in China and India presents risks related to geopolitical factors, regulatory changes, and quality control issues.
Regulatory Scrutiny: Increasing enforcement of GMP standards and quality audits influence supplier qualification and market access.

Future Outlook

The Cialis supply landscape is expected to evolve with advances in manufacturing technology, regulatory harmonization, and potential biosimilar or novel formulations. Continued market entry by high-quality generic producers will likely sustain price competition, enhance drug access, and foster innovation in delivery methods.

Key Takeaways

Dominance of Indian and Chinese manufacturers: India and China dominate tadalafil API production, with Indian firms like Lupin, Aurobindo, and Cipla leading in finished dosage forms.
Post-patent generic proliferation: Patent expiration led to a broad array of generic suppliers, increasing market competition and accessibility.
Quality and regulatory compliance are critical: Suppliers must meet rigorous standards to ensure safety and efficacy, influencing supply reliability.
Supply chain diversification reduces risk: Companies increasingly diversify sources for API and finished products to mitigate geopolitical and regulatory risks.
Emerging regional players expand access: Smaller and regional manufacturers broaden the geographic reach of tadalafil, especially in developing markets.

FAQs

1. Who are the primary suppliers of tadalafil API globally?

The leading API producers include Jiangsu Hengrui Medicine (China), Aurobindo Pharma (India), Zhaoqing Huatian Pharmaceutical (China), and Taj Pharmaceuticals (India).

2. Which companies manufacture generic Cialis?

Generic tadalafil is produced by multiple companies, including Teva, Mylan/Viatris, Lupin, Sun Pharma, Aurobindo, Cipla, and others, following patent expiry.

3. Are there regional differences in Cialis suppliers?

Yes. While global players dominate Western markets, regional companies in Asia, Africa, and Latin America serve local needs, often at lower costs, with varying regulatory standards.

4. What are the risks associated with the current Cialis supply chain?

Risks include reliance on API production in China and India, potential regulatory non-compliance, geopolitical tensions, and manufacturing disruptions.

5. How is the market for Cialis evolving with generics?

The proliferation of high-quality generics has increased competition, led to reduced pricing, improved access worldwide, and prompted manufacturers to ensure strict regulatory adherence for continued market viability.

Sources
[1] U.S. Food and Drug Administration. “Approved Drug Products with Therapeutic Equivalence Evaluations,” 2022.
[2] European Medicines Agency. “Summary of Product Characteristics - Cialis,” 2023.
[3] Chinese State Drug Administration (CSDA). “API Manufacturers Directory,” 2021.
[4] Indian Pharmaceutical Association. “API and Generics Market Overview,” 2022.
[5] MarketWatch. “Tadalafil Market Growth and Trends,” 2023.

Suppliers and packagers for cialis

cialis

Suppliers for the Pharmaceutical Drug CIALIS