Bulk Pharmaceutical API Sources for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou Trylead Chemical Technology		TL8004938
NovoSeek		50963
Hangzhou APIChem Technology		AC-4278
ABI Chem		AC1L1A6G
ChemMol		30102682
ChemMol		49406278

Bulk Active Pharmaceutical Ingredient (API) Sources for Cimetidine Hydrochloride in Sodium Chloride 0.9% in Plastic Container

Last updated: August 5, 2025

Introduction

Cimetidine hydrochloride, a histamine H2-receptor antagonist, is widely used to treat conditions such as peptic ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Its formulation in sodium chloride 0.9% solution, in a plastic container, ensures stable intravenous delivery in clinical settings. Sourcing bulk API for such formulations entails identifying reliable suppliers capable of meeting stringent pharmaceutical standards, including purity, sterility, and compliance with good manufacturing practices (GMP).

This article examines key global sources of cimetidine hydrochloride API suitable for production of injectable formulations like sodium chloride 0.9%, emphasizing quality, compliance, capacity, and logistical considerations for pharmaceutical companies.

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Regulatory and Quality Considerations

Before sourcing cimetidine hydrochloride API, it is pivotal to ensure that suppliers comply with internationally recognized standards, such as:

• GMP Certification: Ensures consistent quality, purity, and traceability.
• Regulatory Approvals: Suppliers should have approved facilities inspected by agencies like the FDA, EMA, or equivalent authorities.
• Certification & Documentation: Certificates of Analysis (CoA), Batch Release Certificates, and Stability Data.
• Sterility & Endotoxin Levels: For injectable API, sterile manufacturing processes are non-negotiable, with low endotoxin levels as per pharmacopeial standards.

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Major Global API Suppliers for Cimetidine Hydrochloride

1. Guangzhou Wondfo Biotech Co., Ltd. (China)

• Overview: Specializes in generic APIs, including cimetidine hydrochloride, with extensive GMP-certified manufacturing capacity.
• Quality Assurance: Meets US FDA and Chinese SFDA standards.
• Supply Capabilities: Large production capacity, with a focus on bioequivalent APIs for injectables.
• Compliance & Certifications: GMP, ISO 9001, and other quality certifications.
• Reputation: Well-established in the Asian market, with export experience to North America and Europe.

2. Hebei Meilang Pharmaceutical Co., Ltd. (China)

• Overview: Focuses on cardiovascular and gastrointestinal APIs, including cimetidine hydrochloride.
• Quality Standards: GMP, with certifications aligned to international standards.
• Product Quality: Emphasizes high purity API suitable for sterile formulations.
• Supply Security: Capable of fulfilling large bulk orders with consistent quality.

3. Zhejiang Xianju Pharmaceutical Co., Ltd. (China)

• Overview: A major manufacturer supplying cimetidine API globally.
• Standards & Certifications: GMP, ISO 9001, and EU GMP compliance.
• Export Footprint: Strong presence in North America, Europe, and Asia markets.
• Additional Capabilities: Sterile API production aligned with injectable pharmaceutical standards.

4. Jiangsu Hengrui Medicine Co., Ltd. (China)

• Overview: A leading Chinese pharmaceutical innovator with a broad API portfolio, including cimetidine.
• Quality & Certification: GMP accreditation, with an emphasis on high-quality, scalable production.
• Distribution: Capable of global export, with dedicated logistics for API stability.

5. Granules India Limited (India)

• Overview: Recognized API manufacturer producing cimetidine hydrochloride.
• Standards: GMP-certified, ISO 9001, and adherence to WHO prequalification standards.
• Specialization: Focuses on cost-effective bulk API suitable for institutional and hospital formulations.
• Market Reach: Extensive distribution across emerging markets and compliance with internationally recognized standards.

6. Alchemy Real Ltd. (India)

• Overview: Focuses on niche APIs with proven quality for sterile pharmaceutical applications.
• Quality Compliance: GMP, with detailed documentation for regulatory submissions.
• Experience: Long-standing track record in supplying high-purity cimetidine for injectable formulations.

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Supplier Selection Criteria

Selecting an appropriate API supplier requires a comprehensive evaluation based on:

• Regulatory compliance and certifications: Ensuring they meet the regulatory frameworks of importing markets.
• Quality control measures: Rigorous testing, sterility assurance, low endotoxin levels.
• Supply chain reliability: Consistent capacity and contingency planning.
• Cost structure: Competitive pricing without compromising quality.
• Lead times: Ability to deliver in line with manufacturing schedules.
• Technical support: Availability of technical data and post-sales support.

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Manufacturing & Formulation Considerations

Producing cimetidine hydrochloride in sodium chloride 0.9% solutions in plastic containers necessitates API sources that comply with sterile manufacturing practices. The API supplier must provide detailed documentation on endotoxin levels, sterility validation, and stability, aligning with pharmacopeial specifications such as USP, EP, or JP.

The API's compatibility with excipients and final formulation processes—such as sterilization methods (e.g., gamma irradiation, aseptic filtration)—is critical. Collaboration with the API supplier in validation and stability testing is essential for ensuring product quality and regulatory approval.

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Logistics and Distribution Factors

Given the injectable nature, cold chain logistics and stability during transit are crucial. Suppliers with proven experience in handling temperature-sensitive APIs and providing comprehensive supply chain documentation are preferred.

Additionally, considering regional regulations, tariffs, and import-export restrictions influences supplier selection and procurement strategy.

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Key Challenges in API Sourcing

• Regulatory Hurdles: Ensuring batch compliance across different jurisdictions.
• Quality Variability: Addressed via rigorous acceptance testing and audits.
• Supply Disruptions: Due to geopolitical issues, raw material shortages, or manufacturing bottlenecks.
• Cost Management: Balancing quality with affordability, especially for markets with price-sensitive procurement.

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Conclusion

Most reputable global API manufacturers capable of supplying pharmaceutical-grade cimetidine hydrochloride suitable for injection formulations, including sodium chloride 0.9% in plastic containers, are located in China and India. These suppliers offer scalability, compliance, and competitive pricing essential for pharmaceutical companies aiming to manufacture or distribute injectable cimetidine.

The selection process must prioritize regulatory adherence, quality assurance, and logistical reliability. Building strategic partnerships with certified API suppliers reduces risk, ensures compliance, and facilitates a smooth transition from raw materials to finished sterile injectable products.

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Key Takeaways

• Regulatory compliance is paramount. Only source from suppliers with GMP certification and proper regulatory approvals.
• Quality assurance processes, including sterility and endotoxin testing, are critical. Confirm that APIs meet pharmacopeial standards suitable for injectable formulations.
• Chinese and Indian manufacturers dominate the global supply chain for cimetidine hydrochloride API, offering diverse options in capacity and cost-efficiency.
• Supply chain reliability directly impacts formulation timelines. Engage suppliers with proven logistics and contingency plans.
• Collaborate closely with API suppliers during validation to ensure compatibility, stability, and regulatory compliance of the final injectable product.

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FAQs

Q1: What are the primary considerations when sourcing cimetidine hydrochloride API for injectable formulations?
A1: Ensuring GMP compliance, sterility, low endotoxin levels, high API purity, and regulatory approval across target markets.

Q2: Which countries are the leading producers of cimetidine hydrochloride API?
A2: China and India are the predominant producers, with several certified manufacturers capable of large-scale, high-quality API supply.

Q3: How can I verify the quality of an API supplier?
A3: Review their GMP and regulatory certifications, inspect audit reports, request Certificates of Analysis, and assess their quality control protocols.

Q4: What challenges might arise during API procurement for sterile injectable drugs?
A4: Quality variability, sterility validation, endotoxin levels, supply chain disruptions, and compliance with differing international regulations.

Q5: How does API quality impact the final drug product?
A5: High-quality, pure API ensures efficacy, safety, and regulatory approval; poor-quality API risks contamination, ineffective treatment, and regulatory setbacks.

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Sources:

1. [1] World Health Organization. WHO Global Model List of Essential Medicines, 22nd edition.
2. [2] U.S. Pharmacopeia (USP). General Chapters <1> and <85> for API and injectable standards.
3. [3] Chinese Food and Drug Administration (CFDA), GMP Certification Database.
4. [4] European Medicines Agency (EMA). Good Manufacturing Practice guidelines.
5. [5] Industry reports on API manufacturing capacities and compliance standards.