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Suppliers and packagers for generic pharmaceutical drug: CIMETIDINE HYDROCHLORIDE
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CIMETIDINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Chartwell Molecular | CIMETIDINE HYDROCHLORIDE | cimetidine hydrochloride | SOLUTION;ORAL | 074251 | ANDA | Chartwell RX, LLC | 62135-809-24 | 2 TRAY in 1 BOX (62135-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-809-05) | 1994-12-22 |
| Chartwell Molecular | CIMETIDINE HYDROCHLORIDE | cimetidine hydrochloride | SOLUTION;ORAL | 074251 | ANDA | Chartwell RX, LLC | 62135-809-37 | 237 mL in 1 BOTTLE (62135-809-37) | 1994-12-22 |
| Chartwell Molecular | CIMETIDINE HYDROCHLORIDE | cimetidine hydrochloride | SOLUTION;ORAL | 074251 | ANDA | Chartwell Governmental & Specialty RX, LLC. | 68999-809-24 | 2 TRAY in 1 BOX (68999-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-809-05) | 1994-12-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cimetidine Hydrochloride
Introduction
Cimetidine hydrochloride is a widely used H2-receptor antagonist primarily prescribed for conditions such as gastric and duodenal ulcers, Zollinger-Ellison syndrome, and gastroesophageal reflux disease (GERD). Its pharmacological efficacy, stability, and clinical safety profile have sustained demand across global markets. As a critical component in therapeutic regimens, ensuring a reliable, high-quality supply chain of cimetidine hydrochloride is vital for pharmaceutical manufacturers, healthcare providers, and patients.
This report provides a comprehensive overview of key suppliers for cimetidine hydrochloride, examining their manufacturing capabilities, regulatory standing, geographic distribution, and market significance. The aim is to offer actionable insights into sourcing strategies, industry trends, and supplier reliability for stakeholders within the pharmaceutical supply chain.
Manufacturers of Cimetidine Hydrochloride
The primary suppliers of cimetidine hydrochloride are established pharmaceutical ingredient (API) manufacturers capable of producing high-purity, bacteriostatic-grade cimetidine suitable for formulations. Key players include:
1. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
A leading Chinese API manufacturer, Zhejiang Huahai produces cimetidine hydrochloride adhering to international quality standards (e.g., USP, EP). Recognized for its extensive API portfolio and robust manufacturing infrastructure, the company supplies both domestic and global markets. Their capacity includes large-scale production, with comprehensive compliance to cGMP regulations, making their product suitable for both generics and branded formulations.
2. Jiangsu Hengrui Medicine Co., Ltd. (China)
Hengrui is a prominent player in the Chinese pharmaceutical industry, with a dedicated focus on API manufacturing. Their cimetidine hydrochloride is produced under stringent quality control protocols, meeting both national and international pharmacopeia standards. Their strategic focus on R&D and manufacturing scale positions them as a key supplier for multinational pharmaceutical companies.
3. CAPOT, Inc. (South Korea)
South Korea’s CAPOT specializes in market-leading APIs, including cimetidine hydrochloride. Their manufacturing facilities are certified with ISO standards, and they have achieved compliance with cGMP, ensuring product quality and regulatory acceptance in diversified markets. Their reputation is anchored in reliable supply and consistent quality.
4. Solara Active Pharma Sciences (India)
As part of the Indian pharmaceutical manufacturing sector, Solara manufactures cimetidine hydrochloride with a focus on affordability and quality. Their production is aligned with global standards, with export commitments across North America, Europe, and Asia. Their strategic positioning caters to generic drug production requirements.
5. Zhejiang NHU Co., Ltd. (China)
NHU is another significant Chinese API producer with a diversified portfolio. The company invests heavily in quality assurance and process innovation, offering cimetidine hydrochloride that conforms to international pharmacopoeia standards. Their global distribution network enhances market access.
Emerging and Niche Suppliers
In addition to established giants, niche suppliers and regional producers support the global supply via regional markets or specialized formulations:
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API Manufacturing in India: Many smaller Indian firms manufacture cimetidine hydrochloride for regional markets, often tailored for cost-effective supply, including companies such as S. R. Pharma, Gujarat, and Aarti Drugs.
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Synthetic Pathway Innovators: Some suppliers employ innovative synthesis pathways to improve yield, purity, or sustainability, providing potential for supply chain resilience.
Regulatory Considerations
Suppliers must comply with strict regulatory standards, including the US FDA, EMA, PMDA, and WHO prequalification. Many top suppliers hold certifications such as cGMP, ISO 9001, and have passed regulatory inspections, facilitating global market access. Buyers should verify the supplier’s regulatory standing, including review of Drug Master Files (DMFs) and Certificate of Suitability (CEPfS) filings.
Market Trends and Supply Chain Dynamics
The global demand for cimetidine hydrochloride has experienced fluctuations influenced by patent expirations, generic market expansion, and evolving treatment guidelines. The Asian manufacturing hub, particularly China and India, dominates global supply due to cost advantages and scale. However, the COVID-19 pandemic strained supply chains, prompting stakeholders to diversify sources. The increased scrutiny on quality, regulatory compliance, and supply chain transparency underscores the importance of vetted, reliable suppliers.
Strategic Sourcing Recommendations
- Vendor Qualification: Verify suppliers' compliance with international standards, inspection reports, and regulatory credentials.
- Diversification: Avoid reliance on a single supplier by developing a multi-source strategy amid geopolitical and logistical uncertainties.
- Quality Assurance: Prioritize suppliers with proven record of consistent quality, stability, and regulatory approval.
- Long-term Agreements: Engage in contracts ensuring supply continuity and price stability to mitigate market volatility.
Conclusion
The market for cimetidine hydrochloride is characterized by prominent Asian manufacturers, especially Chinese and Indian API producers, supported by South Korean firms. The landscape continues to evolve with regulatory reforms, technological advances, and global supply chain resilience efforts. Sourcing from reputable, compliant suppliers remains crucial to ensuring high-quality, reliable supply for formulators and healthcare providers.
Key Takeaways
- Leading suppliers include Zhejiang Huahai, Jiangsu Hengrui, CAPOT, Solara, and Zhejiang NHU, mainly based in China, South Korea, and India.
- Suppliers must demonstrate compliance with cGMP and international pharmacopeia standards for global acceptance.
- Supply chain diversification minimizes risk posed by geopolitical tensions, logistical disruptions, and regulatory changes.
- Strategic verification of supplier capabilities and regulatory standing ensures quality, safety, and uninterrupted supply.
- Ongoing innovation and quality improvement efforts among manufacturers support competitive positioning and market stability.
FAQs
1. Who are the main global suppliers of cimetidine hydrochloride?
Major suppliers include Chinese companies Zhejiang Huahai and Jiangsu Hengrui, South Korea’s CAPOT, and Indian firms like Solara Active Pharma Sciences. These manufacturers produce high-quality API conforming to international standards for both domestic and export markets.
2. What regulatory certifications should I verify when sourcing cimetidine hydrochloride?
Buyers should confirm cGMP compliance, ISO certifications, and pharmacopoeia standards (USP, EP). Additionally, certifications like DMFs and CEPs are critical for regulatory acceptance in key markets.
3. How has the COVID-19 pandemic affected the supply of cimetidine hydrochloride?
The pandemic disrupted global logistics and manufacturing, leading to supply shortages and increased demand for diversified sourcing. Many companies are now prioritizing supply chain resilience through multi-sourcing strategies.
4. Are there regional differences in supplier reliability?
While Chinese and Indian manufacturers dominate due to capacity and cost advantages, regulatory compliance and supply stability vary. South Korean firms often prioritize regulatory rigor, providing added assurance.
5. What should buyers consider when selecting a cimetidine hydrochloride supplier?
Buyers should evaluate technical capabilities, manufacturing certifications, supply capacity, reputation for consistent quality, and regulatory track record. Establishing strategic partnerships and long-term agreements enhances supply security.
References
- U.S. Pharmacopeia (USP). Monograph on cimetidine.
- European Pharmacopoeia (EP). Cimetidine monograph.
- Zhejiang Huahai Pharmaceutical Co., Ltd. Public disclosures.
- Jiangsu Hengrui Medicine Co., Ltd. Official website.
- International API market analysis reports, 2022.
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