Suppliers and packagers for generic pharmaceutical drug: CIMETIDINE

CIMETIDINE

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

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

Cimetidine API Suppliers Analysis

Last updated: February 19, 2026

This report details the current landscape of active pharmaceutical ingredient (API) suppliers for cimetidine. It identifies key manufacturers, their production capabilities, regulatory standing, and potential supply chain vulnerabilities. Understanding these factors is critical for pharmaceutical companies seeking reliable sourcing or evaluating competitive positioning.

What is Cimetidine and Its Market Significance?

Cimetidine, a histamine H2-receptor antagonist, is primarily used to reduce stomach acid production. It is prescribed for conditions including peptic ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. While newer proton pump inhibitors (PPIs) and other H2 blockers have gained market share, cimetidine remains a relevant, lower-cost treatment option, particularly in certain geographic markets and for specific patient populations. Its generic status means the market is price-sensitive, placing a premium on efficient and cost-effective API production.

Key Cimetidine API Manufacturers

The production of cimetidine API is concentrated among a limited number of global manufacturers. These companies often possess established expertise in complex organic synthesis and adhere to stringent quality control standards.

• Shandong Xinhua Pharmaceutical Co., Ltd.

  • Location: Shandong, China
  • Reputation: A significant player in China's pharmaceutical API market, with a broad portfolio.
  • Certifications: Likely holds GMP certifications from various regulatory bodies, including Chinese NMPA. Specific FDA or EMA certifications require direct verification.
  • Production Scale: Operates large-scale production facilities. Specific cimetidine capacity is not publicly disclosed but is understood to be substantial.

• IOL Chemicals and Pharmaceuticals Ltd.

  • Location: Punjab, India
  • Reputation: An established Indian API manufacturer with a focus on bulk drugs.
  • Certifications: Holds WHO-GMP, US FDA, and EDQM certifications for various products. Direct cimetidine certification status should be confirmed.
  • Production Scale: Has a considerable manufacturing footprint for multiple APIs, including cimetidine.

• Granules India Ltd.

  • Location: Telangana, India
  • Reputation: A vertically integrated pharmaceutical company with a strong API business segment.
  • Certifications: Holds US FDA, EDQM, and other international accreditations. Specific cimetidine site approvals are critical.
  • Production Scale: Operates multiple API manufacturing facilities; cimetidine is part of their established product list.

• Zhejiang Huahai Pharmaceutical Co., Ltd.

  • Location: Zhejiang, China
  • Reputation: A major API exporter, particularly to regulated markets like the US and Europe.
  • Certifications: Known for holding US FDA, EMA, and other international certifications for many of its APIs. Direct cimetidine site and product specific audits are essential for confirmation.
  • Production Scale: Possesses advanced manufacturing capabilities and significant capacity.

• Anuh Pharma Ltd.

  • Location: Maharashtra, India
  • Reputation: An Indian API producer with a focus on APIs for anti-ulcer and anti-infective segments.
  • Certifications: Typically adheres to GMP standards. Verification of US FDA or EMA compliance for cimetidine is necessary.
  • Production Scale: Operates a dedicated API manufacturing unit.

Table 1: Overview of Key Cimetidine API Suppliers

Manufacturer	Primary Location	Notable Certifications (General)	Key Product Focus
Shandong Xinhua Pharmaceutical	China	NMPA GMP	Broad API portfolio
IOL Chemicals and Pharmaceuticals	India	WHO-GMP, US FDA, EDQM	Bulk drugs, intermediates
Granules India Ltd.	India	US FDA, EDQM	Vertically integrated APIs, CF/RCF APIs
Zhejiang Huahai Pharmaceutical	China	US FDA, EMA	APIs for regulated markets, intermediates
Anuh Pharma Ltd.	India	GMP	Anti-ulcer, anti-infective APIs

Note: Specific cimetidine product and site certifications for regulated markets (e.g., US FDA, EMA) require direct verification through the manufacturer's regulatory filings or by contacting the company directly.

Regulatory Compliance and Quality Assurance

The pharmaceutical industry demands rigorous adherence to Good Manufacturing Practices (GMP). For cimetidine API, this means manufacturers must comply with guidelines set by major regulatory bodies, including:

• U.S. Food and Drug Administration (FDA): Manufacturers supplying to the US market must have their facilities inspected and approved by the FDA. Site-specific drug master files (DMFs) are critical.
• European Medicines Agency (EMA) and National Competent Authorities: For the European Union market, API manufacturers need to comply with EU GMP guidelines. Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) are often required.
• National Medical Products Administration (NMPA) of China: Chinese GMP standards are essential for domestic supply and increasingly recognized internationally.
• World Health Organization (WHO) GMP: Widely adopted, particularly for emerging markets.

The quality of cimetidine API is assessed through pharmacopoeial standards such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). Key quality attributes include:

• Assay: The purity of the cimetidine substance.
• Related Substances/Impurities: Control of process impurities and degradation products.
• Residual Solvents: Limits on solvents used during synthesis.
• Heavy Metals: Strict limits on elemental impurities.
• Physical Characteristics: Particle size distribution and polymorphism can impact downstream formulation and bioavailability.

A single regulatory non-compliance event at a supplier's facility can disrupt the supply chain for multiple pharmaceutical companies. For example, recalls or import alerts issued by the FDA due to quality issues can lead to immediate product shortages.

Production Processes and Supply Chain Considerations

The synthesis of cimetidine involves a multi-step chemical process. Common synthetic routes typically start from readily available raw materials and involve intermediates such as:

• N-methyl-2-nitro-5-(2-mercaptoethyl)imidazole
• Guanidine derivatives
• Cyanoguanidine

The complexity of these syntheses means that intermediate suppliers also play a crucial role in the cimetidine supply chain. Disruptions at the intermediate level can cascade to API manufacturers.

Key supply chain considerations include:

• Geographic Concentration: A significant portion of API manufacturing for many generic drugs, including cimetidine, is concentrated in China and India. This concentration presents risks related to geopolitical stability, trade policies, and localized environmental regulations.
• Raw Material Availability: The availability and cost of key starting materials and reagents can fluctuate, impacting API production costs and lead times.
• Logistics and Transportation: Global shipping disruptions, customs delays, and fluctuating freight costs can affect the timely delivery of API.
• Intellectual Property: While cimetidine itself is off-patent, the manufacturing processes and specific polymorphs can be subject to process patents, although this is less common for such an established molecule.
• Capacity Utilization: Manufacturers may allocate capacity based on market demand and profitability, potentially leading to allocation issues if demand spikes unexpectedly.

Competitive Landscape and Pricing Dynamics

The cimetidine API market is characterized by:

• Generic Competition: The absence of patent protection for cimetidine means the market is driven by cost efficiency.
• Price Sensitivity: Pharmaceutical companies seeking cimetidine API are highly sensitive to price. This forces API manufacturers to optimize production and supply chains to remain competitive.
• Differentiated Suppliers: While price is paramount, some suppliers may differentiate themselves through superior quality control, regulatory track record, or reliability of supply.
• Consolidation: The generic API market has seen consolidation, with larger players acquiring smaller ones to gain scale and market share.

Pricing for cimetidine API can vary significantly based on volume, supplier, quality certifications, and geographic origin. Manufacturers in China and India generally offer competitive pricing due to lower labor and operational costs. However, companies in regulated markets may command a premium if they offer specific advantages in quality assurance or regulatory support.

Emerging Trends and Future Outlook

The cimetidine API market, while mature, is influenced by broader pharmaceutical industry trends:

• Increased Regulatory Scrutiny: Regulatory agencies worldwide are intensifying their oversight of API manufacturing, particularly concerning data integrity and impurity control. This requires continuous investment in quality systems by manufacturers.
• Supply Chain Resilience: Recent global events have highlighted the need for diversified and resilient supply chains. Pharmaceutical companies are increasingly looking to de-risk by qualifying multiple suppliers across different geographies.
• Focus on Sustainability: Environmental, social, and governance (ESG) factors are becoming more important. API manufacturers facing pressure to adopt greener chemical processes and reduce their environmental footprint.
• Technological Advancements: While cimetidine synthesis is well-established, advancements in continuous manufacturing and process analytical technology (PAT) could offer incremental efficiency gains.

Despite the rise of newer drug classes, cimetidine is expected to maintain a stable, albeit modest, market presence. Its affordability and established efficacy ensure continued demand, particularly in regions with price-sensitive healthcare systems. The primary challenges for suppliers will be navigating increasing regulatory demands and maintaining cost competitiveness.

Key Takeaways

• The global supply of cimetidine API is concentrated among a few key manufacturers, primarily in China and India.
• Regulatory compliance, particularly with US FDA and EMA standards, is a critical differentiator for suppliers serving developed markets.
• Supply chain risks are amplified by geographic concentration and potential disruptions in raw material sourcing or logistics.
• The cimetidine API market is highly price-sensitive due to its generic status, emphasizing the need for efficient production.
• Future supply chain strategies will likely prioritize resilience through diversification and rigorous quality management.

Frequently Asked Questions

1. Which regulatory bodies' GMP certifications are most critical for cimetidine API suppliers targeting developed markets? The most critical certifications are those from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) or national competent authorities within the EU. Compliance with pharmacopoeial standards like USP and Ph. Eur. is also essential.

2. What are the primary risks associated with sourcing cimetidine API from a single supplier? The primary risks include supply chain disruption due to the supplier's production issues (e.g., quality failures, capacity constraints), geopolitical instability affecting the supplier's region, natural disasters, or changes in trade policies. A single point of failure can lead to product shortages.

3. How do intermediate suppliers impact the overall cimetidine API supply chain reliability? Intermediate suppliers provide the chemical building blocks for cimetidine API synthesis. Any disruption in their production, quality, or delivery of these intermediates can directly halt or delay API manufacturing. The reliability of the entire cimetidine supply chain is thus dependent on the robustness of its intermediate supply.

4. Are there any significant process patents that might restrict the manufacturing of cimetidine API? Cimetidine itself is a well-established, off-patent molecule. While novel synthetic routes or specific polymorphic forms could theoretically be patented, the common and established manufacturing processes for cimetidine are unlikely to be significantly constrained by active process patents in major markets. However, due diligence is always recommended.

5. What is the typical lead time for ordering cimetidine API from a major manufacturer? Typical lead times can range from 4 to 12 weeks, depending on the supplier's current production schedule, order volume, and existing inventory. Urgent or very large orders may require longer lead times or staggered delivery schedules. Factors like customs clearance and shipping further influence the total delivery duration.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from https://www.fda.gov/drugs/drug-master-files [2] European Medicines Agency. (n.d.). Active substance master file procedure. Retrieved from https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice/active-substance-master-file-procedure [3] United States Pharmacopeia. (n.d.). Cimetidine. In USP-NF. Retrieved from https://www.uspnf.com/ [4] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from https://www.edqm.eu/ [5] World Health Organization. (n.d.). Good manufacturing practices for pharmaceutical products. Retrieved from https://www.who.int/