cimetidine: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	CIMETIDINE	cimetidine	TABLET;ORAL	218997	ANDA	Aurobindo Pharma Limited	59651-823-01	100 TABLET, FILM COATED in 1 BOTTLE (59651-823-01)	2024-11-12
Aurobindo Pharma Ltd	CIMETIDINE	cimetidine	TABLET;ORAL	218997	ANDA	Aurobindo Pharma Limited	59651-824-01	100 TABLET, FILM COATED in 1 BOTTLE (59651-824-01)	2024-11-12
Aurobindo Pharma Ltd	CIMETIDINE	cimetidine	TABLET;ORAL	218997	ANDA	Aurobindo Pharma Limited	59651-825-01	100 TABLET, FILM COATED in 1 BOTTLE (59651-825-01)	2024-11-12
Aurobindo Pharma Ltd	CIMETIDINE	cimetidine	TABLET;ORAL	218997	ANDA	Aurobindo Pharma Limited	59651-825-05	500 TABLET, FILM COATED in 1 BOTTLE (59651-825-05)	2024-11-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Cimetidine, a histamine H2 receptor antagonist, was once a widely prescribed medication for the treatment of ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Developed in the 1970s and introduced into the pharmaceutical market shortly thereafter, cimetidine marked a significant advancement in acid suppression therapy. Although its prominence has diminished due to newer agents like ranitidine and omeprazole, cimetidine remains relevant in certain therapeutic contexts and as a research compound. Accordingly, understanding the landscape of suppliers—manufacturers, raw material providers, and distributors—is essential for stakeholders navigating the cimetidine supply chain.

This analysis systematically examines key suppliers specializing in cimetidine, considering factors such as manufacturing capacities, geographic distribution, regulatory status, and market trends to inform strategic decisions within pharmaceutical procurement, research, or licensing.

Manufacturers of Cimetidine

1. Major Pharmaceutical Companies Producing Cimetidine

A. Novartis (Sandoz division)

Novartis, through its generic division Sandoz, has historically been a significant supplier of cimetidine. The company has maintained manufacturing facilities in Switzerland and India, producing both brand and generic formulations.
Sandoz’s manufacturing complies with international Good Manufacturing Practices (GMP), ensuring high-quality standards suitable for various markets.

B. Dr. Reddy’s Laboratories

An India-based pharmaceutical giant, Dr. Reddy’s manufactures cimetidine both domestically and for export.
The company has invested in high-capacity manufacturing plants located in India, holding requisite regulatory approvals such as the US FDA approval, facilitating broad distribution.

C. Teva Pharmaceuticals

Teva, headquartered in Israel, manufactures cimetidine as part of its extensive generic portfolio.
Their production facilities in Europe and North America serve markets globally, with an emphasis on cost-effectiveness and regulatory compliance.

D. Glenmark Pharmaceuticals

Glenmark has sustained cimetidine manufacturing in India, with exports to North America, Europe, and Asia.
The company’s facilities are GMP-certified, with a focus on maintaining drug quality and supply reliability.

E. Other Notable Manufacturers

Mylan (now part of Viatris): For many years, Mylan supplied cimetidine to global markets.
Sun Pharmaceutical Industries: A key player in the Indian generic sector, offering cimetidine to emerging markets.
Zhejiang Hisun Pharmaceuticals: Based in China, engaged in cimetidine production for local and international markets.

2. Emerging and Regional Suppliers

Regional manufacturers, especially in India, China, and Eastern Europe, continue to produce cimetidine to meet local demand, often at lower costs. These suppliers frequently operate under direct licensing agreements or produce under patent licenses where applicable.

Raw Material Suppliers for Cimetidine

1. Key APIs (Active Pharmaceutical Ingredient) Suppliers

The production of cimetidine begins with high-quality raw materials and intermediates:

Imidazole Derivatives Suppliers: Many API producers source intermediates such as 2-methylimidazole and other precursor chemicals from specialty chemical suppliers globally.
Chemical Intermediates Manufacturers: Companies like Loba Chemie (India) and Alfa Aesar (US) supply various raw materials essential for cimetidine synthesis.

2. Contract Manufactures of APIs

Several chemical manufacturers contract production of cimetidine APIs:

Jiangxi Ganglong Pharmaceutical Co., Ltd. (China): Known to produce APIs for cimetidine.
Hikal Ltd. (India): Offers custom synthesis and bulk APIs, including cimetidine precursors.
CimmTech (European-based specialty chemical manufacturer): Supplies chemical intermediates for pharmaceutical synthesis.

3. Supply Chain Considerations

The reliance on Chinese and Indian API suppliers remains high due to manufacturing scalability and cost advantages. However, geopolitical and regulatory changes influence raw material sourcing, prompting diversification of supply chains.

Distribution Channels and Major Suppliers

1. Global Pharmaceutical Distributors

McKesson Corporation and AmerisourceBergen serve as significant distributors for generic cimetidine formulations, supplying hospitals and pharmacies across North America.
Phoenix Pharma and Sinopharm Group distribute cimetidine within China and neighboring regions.

2. Online and Local Pharmacies

Certain regional and online pharmacies source cimetidine directly from approved generic manufacturers or through distribution partners to serve local markets.

3. Contract Manufacturing Organizations (CMOs)

CMOs like CoreRx and Fitzgerald often secure production contracts for cimetidine formulations, especially in sterile and non-sterile oral dosage forms.

Regulatory and Market Dynamics Influencing Supply

The transition from patent-protected formulations to generic equivalents has lowered market entry barriers, leading to an increasing number of smaller manufacturers globally. Regulatory agencies such as the US FDA, EMA, and MHRA oversee manufacturing quality and compliance, impacting supplier credibility.

Recent formulations of cimetidine have been phased out or reduced in many markets due to safety concerns (e.g., ranitidine-related carcinogenic impurities) or market shifts towards proton pump inhibitors. Despite this, robust manufacturing capabilities persist.

Challenges in the Cimetidine Supply Chain

Regulatory Constraints: Strict quality standards and evolving regulatory requirements can impede supplier entry or continuity.
Market Decline: Decreasing prescriptions influence market viability, impacting manufacturing scale and investment.
Raw Material Scarcity: Over-reliance on Asian suppliers can pose risks associated with geopolitical tensions, supply disruptions, and quality control.
Environmental and Safety Regulations: Stricter environmental standards influence the production process and supplier selection.

Future Outlook and Strategic Considerations

Despite decreased global demand, cimetidine remains relevant for specific niches, including research, veterinary medicine, and countries with limited access to newer drugs. Suppliers with flexible manufacturing, strong quality compliance, and diversified sourcing will better navigate market challenges.

Partnerships with regional API producers and the adoption of continuous manufacturing techniques can optimize supply chains. Additionally, potential licensing opportunities with patent holders or rights to manufacture under patent expiration could expand supplier base.

Key Takeaways

The primary manufacturers of cimetidine are established generic pharmaceutical companies, with India, China, and Israel being significant production hubs.
Raw material supply chains hinge on international chemical suppliers, especially in Asia, necessitating diversification to mitigate geopolitical and regulatory risks.
The global distribution network comprises large-scale distributors, regional suppliers, and online pharmacies, with structured oversight from regulatory bodies.
Market decline influences supplier stability; however, niche applications and geographic demand sustain manufacturing activity.
Strategic sourcing should emphasize regulatory compliance, supply chain resilience, and adaptability amid changing market dynamics.

FAQs

Q1. Are there any patent restrictions on cimetidine today?
A1. Cimetidine's original patents have expired globally, allowing generic manufacturers to produce it freely. However, specific formulations or patents related to particular delivery mechanisms may still be protected in certain jurisdictions.

Q2. Which countries are the largest producers of cimetidine?
A2. India and China dominate cimetidine production due to their extensive generic pharmaceutical industries and chemical manufacturing capacity.

Q3. Is cimetidine still widely supplied worldwide?
A3. While supply has decreased in some markets, cimetidine remains available in developing countries, research settings, and for specific therapeutic uses, supported by multiple manufacturers.

Q4. What are the main raw materials used in the synthesis of cimetidine?
A4. Key raw materials include imidazole derivatives, methylamine, and other specialized intermediates used in the multi-step synthesis process.

Q5. How do regulatory standards impact procurement of cimetidine?
A5. Stringent compliance with GMP, GMP-certified manufacturing facilities, and regulatory approvals (e.g., FDA, EMA) are crucial for ensuring quality and market access during procurement and licensing.

References:
[1] “Cimetidine,” U.S. National Library of Medicine, DailyMed.
[2] "Global API Manufacturing," Pharmaceutical Technology, 2021.
[3] "Market Outlook for H2 Antagonists," IQVIA, 2022.
[4] "Indian Pharmaceutical Industry," Department of Pharmaceuticals, Government of India, 2023.
[5] “Regulatory Overview of Generic Drugs,” EMA, 2022.

Suppliers and packagers for cimetidine

cimetidine

Suppliers for the Pharmaceutical Drug: CIMETIDINE