Bulk Pharmaceutical API Sources for TAGAMET HB 200

Bulk Pharmaceutical API Sources for TAGAMET HB 200

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C4522_SIGMA
TCI (Tokyo Chemical Industry)		C1252
Molport		MolPort-001-838-193

Bulk Active Pharmaceutical Ingredient (API) Sources for: TAGAMET HB 200

Last updated: July 30, 2025

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Introduction

The pharmaceutical industry continually seeks reliable sources for Active Pharmaceutical Ingredients (APIs) to ensure product quality, regulatory compliance, and supply chain stability. TAGAMET HB 200, whose active component is cimetidine, is a widely used histamine H2-receptor antagonist for managing conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. Sourcing bulk cimetidine API demands meticulous evaluation due to regulatory standards, batch consistency, and supply logistics.

This analysis explores the principal global suppliers of cimetidine API suitable for manufacturing TAGAMET HB 200. It aims to guide pharmaceutical manufacturers, procurement managers, and regulatory professionals in identifying reputable API sources aligned with industry standards.

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Understanding TAGAMET HB 200 and Its API

TAGAMET HB 200 contains 200 mg of cimetidine per film-coated tablet. The API, cimetidine, was first introduced in the 1970s and remains prescribed globally. Sourcing cimetidine API involves ensuring compliance with pharmacopeial standards such as USP, EP, or other regional pharmacopoeias, which dictate purity, impurity profiles, and manufacturing practices.

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Global API Suppliers for Cimetidine

1. Major Manufacturers and Their Capabilities

a. Jubilant Hollistik Limited (India)
Jubilant Hollistik is a leading Indian contract manufacturing organization specializing in cimetidine API. It holds regulatory approvals from agencies like the US FDA, EDQM, and ANVISA. The company offers high-purity cimetidine API batches compliant with USP/EP standards, with proven manufacturing scale and consistent supply.

b. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
Huahai is a prominent Chinese pharma exporter with large-scale production of various APIs, including cimetidine. Their facilities adhere to GMP standards, and they supply cimetidine API globally, mainly to North America, Europe, and Asia. Their manufacturing processes focus on high-quality batches with controlled impurity profiles.

c. Aurobindo Pharma Limited (India)
Aurobindo has an extensive API portfolio, including cimetidine. Their API manufacturing facilities are GMP-certified, with global regulatory registra­tions. Their cimetidine API undergoes rigorous testing for purity and is suitable for pharmaceutical formulation.

d. Zhangjiagang Hengli Pharmaceutical Co., Ltd. (China)
Hengli supplies cimetidine API to manufacturers seeking cost-effective yet compliant sources. They maintain cGMP certifications and adhere to international quality standards, providing consistent API quality suitable for finished dosage form manufacturing.

e. Teva Pharmaceutical Industries Ltd. (Israel) and Other Big Pharma Suppliers
Though primarily a finished dosage manufacturer, Teva and similar companies sometimes supply bulk cimetidine APIs, especially for their in-house production or licensed product manufacturing.

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Regulatory and Quality Considerations

a. Regulatory approvals
For global supply, APIs must meet regulatory standards such as the USFDA, EMA, or PMDA. Suppliers with current registrations or GMP accreditation offer higher assurance of compliance. For TAGAMET HB 200, it is critical to source API batches with documented stability, purity (>99%), and low levels of potential impurities.

b. Quality testing
Suppliers should provide detailed Certificate of Analysis (CoA) covering assay, residual solvents, heavy metals, microbial limits, and impurity profiling. Validated analytical methods aligned with pharmacopeial standards are non-negotiable.

c. Supply chain stability
Reputable suppliers with established manufacturing capacity and history of reliable delivery mitigate risks associated with shortages or regulatory non-compliance.

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Sourcing Strategies

a. Tiered sourcing
Global procurement often involves a mix of Tier 1 (high-volume, well-validated manufacturers), Tier 2 (regional suppliers with good compliance history), and emerging suppliers capable of offering competitive pricing.

b. Due diligence
Perform comprehensive audits, site visits, and technical evaluations. Review prior regulatory inspections, compliance history, and customer feedback.

c. Contractual considerations
Incorporate quality agreements, supply conditions, and contingency clauses addressing potential regulatory changes or supply interruptions.

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Supply Chain and Market Trends

The landscape of API sourcing for cimetidine has remained relatively stable over the past decade. However, recent regulatory shifts, such as US FDA import alerts on certain Chinese and Indian manufacturing sites, necessitate careful supplier vetting. Diversification strategies, including sourcing from multiple approved suppliers, mitigate geopolitical and regulatory risks.

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Conclusion

The procurement of cimetidine API for TAGAMET HB 200 production centers on selecting suppliers with proven manufacturing excellence, regulatory compliance, robust supply chains, and quality assurance measures. Indian firms like Jubilant Hollistik and Aurobindo, alongside Chinese leaders such as Zhejiang Huahai and Hengli, represent primary sources, offering a combination of cost-effectiveness and compliance. Ensuring API authenticity and quality through rigorous supplier qualification remains paramount for continuous, compliant production.

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Key Takeaways

• Due diligence and validation of API suppliers are critical for regulatory compliance and product quality.
• Major Asian manufacturers, especially from India and China, dominate the cimetidine API supply chain, but regulatory environments demand strict oversight.
• Suppliers with authoritative GMP certifications and current pharmacopeial compliance are preferred options.
• Diversifying suppliers mitigates risks linked to geopolitical tensions, regulatory changes, or supply disruptions.
• Regular audits, comprehensive testing, and transparent documentation uphold the integrity of the supply chain.

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FAQs

1. What are the primary factors in selecting an API supplier for cimetidine?
Regulatory compliance, quality assurance, manufacturing capacity, purity levels, impurity profiles, delivery reliability, and documentation quality.

2. How do regulatory agencies influence sourcing decisions for cimetidine API?
Agencies like the US FDA, EMA, and other regional authorities require GMP certification, validation dossiers, and batch testing records to approve API sources, influencing supplier selection.

3. Are there any recent regulatory concerns related to cimetidine API suppliers?
Yes, certain Chinese and Indian manufacturers have faced import alerts or GMP violations, necessitating careful qualification and ongoing monitoring.

4. What are the typical quality attributes checked for cimetidine API?
Purity (>99%), impurity profile, residual solvents, heavy metals, microbial limits, stability data, and USP/EP compliance certificates.

5. Can I rely on emerging API suppliers for TAGAMET HB 200?
While emerging suppliers may offer cost advantages, rigorous qualification and validation processes are essential to ensure they meet all quality, regulatory, and consistency standards.

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Sources:

1. [1] U.S. Pharmacopeia (USP). Cimetidine Monograph.
2. [2] European Pharmacopoeia (EP). Cimetidine Monograph.
3. [3] Jubilant Hollistik official website and GMP certification documentation.
4. [4] Zhejiang Huahai Pharmaceutical annual report and GMP certificate.
5. [5] Aurobindo Pharma API portfolio and regulatory filings.