Bulk Pharmaceutical API Sources for tetrahydrozoline hydrochloride

Bulk Pharmaceutical API Sources for tetrahydrozoline hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T4264_SIGMA
NovoSeek		10648
MP Biomedicals		156806
MolPort		MolPort-000-720-037
Hangzhou APIChem Technology		AC-1110
ISpharm		I14-11410
NIH Clinical Collection		SAM002264650

Bulk Active Pharmaceutical Ingredient (API) Sources for: TETRAHYDROZOLINE HYDROCHLORIDE

Last updated: August 3, 2025

Introduction

Tetrahydrozoline hydrochloride is a widely used ocular decongestant, typically administered via eye drops or nasal sprays. Its rapid vasoconstrictive properties alleviate redness and congestion by constricting blood vessels in the mucous membranes. As a critical component in ophthalmic and nasal formulations, reliable sourcing of bulk Tetrahydrozoline hydrochloride API is essential for pharmaceutical manufacturers, ensuring safety, efficacy, and regulatory compliance. This report investigates current global API suppliers, highlighting sourcing options, quality considerations, regulatory compliance, and market trends.

Overview of Tetrahydrozoline Hydrochloride API Market

The demand for Tetrahydrozoline hydrochloride is driven primarily by the OTC ophthalmic and nasal products sector. The API market has witnessed steady growth, propelled by increased awareness of eye health and allergy management. The API's manufacturing process necessitates stringent purity levels, consistent supply, and adherence to Good Manufacturing Practices (GMP).

Key manufacturing regions include China, India, and, to a lesser extent, Europe and the United States. These regions host various API producers—both large-scale pharmaceutical manufacturers and specialty chemical suppliers—capable of providing Tetrahydrozoline hydrochloride at pharmaceutical-grade standards.

Major API Suppliers for Tetrahydrozoline Hydrochloride

1. China-Based API Manufacturers

a. Zhejiang Huito Pharmaceutical Co., Ltd.
A leading Chinese API producer, Zhejiang Huito supplies Tetrahydrozoline hydrochloride with GMP certification, catering predominantly to European and North American markets. Their facilities adhere to strict quality standards, and their products comply with pharmacopeial requirements, including the USP and EP.

b. Jiangxi Hongxin Pharmaceutical Co., Ltd.
Known for a comprehensive suite of ophthalmic APIs, Jiangxi Hongxin offers Tetrahydrozoline hydrochloride for global distribution. Their manufacturing process emphasizes high purity, with detailed analytical testing for residual solvents and impurities.

c. Shandong Xinhua Pharmaceutical Co., Ltd.
Specializing in cardiovascular and respiratory APIs, Shandong Xinhua supplies Tetrahydrozoline hydrochloride in bulk, with a focus on quality control and regulatory compliance.

2. India-Based API Manufacturers

a. Cadila Pharmaceuticals
One of India's leading pharmaceutical firms, Cadila has extensive experience in ophthalmic APIs, including Tetrahydrozoline hydrochloride. Their manufacturing facilities comply with WHO-GMP standards, and they supply to global generic markets.

b. Aarti Drugs Ltd.
Aarti Drugs is a prominent Indian API producer with a robust portfolio of ophthalmic and nasal decongestant APIs. Their facilities are certified by multiple international regulators, supporting export to regulated markets.

c. Sun Pharma Laboratories
With a comprehensive manufacturing infrastructure, Sun Pharma offers high-quality Tetrahydrozoline hydrochloride API, emphasizing rigorous QC protocols aligned with international standards.

3. European and U.S. API Suppliers

While fewer in number, certain European and U.S.-based firms supply Tetrahydrozoline hydrochloride through licensing arrangements or custom synthesis partners:

a. Sigma-Aldrich / Merck KGaA
A global supplier offering pharmaceutical-grade Tetrahydrozoline hydrochloride, primarily for research and clinical use, with strict quality assurance systems.

b. Capsugel (a Lonza company)
Provides specialized formulations and APIs including Tetrahydrozoline hydrochloride, with focus on regulatory compliance and pharmaceutical grade purity.

4. Contract Manufacturing Organizations (CMOs)

a. Jubilant Ingrevia (India)
Jubilant Ingrevia offers contract manufacturing services for Tetrahydrozoline hydrochloride, with a focus on scalable production, quality assurance, and compliance with international standards.

b. Hikal Ltd. (India)
Specializing in custom synthesis and bulk APIs, Hikal provides Tetrahydrozoline hydrochloride with GMP certifications, supporting both formulations and research activities.

Sources and Supply Chain Considerations

When sourcing Tetrahydrozoline hydrochloride, pharmaceutical companies must evaluate:

• Regulatory compliance: Suppliers must demonstrate adherence to GMP, DMF (Drug Master File) filings, and pharmacopeial standards (USP, EP, JP).
• Quality control: Certificates of Analysis (CoA), impurity profiles, residual solvent tests, and stability data are essential.
• Supply reliability: Capacity to fulfill volume demands and consistent delivery timelines.
• Pricing and lead times: Competitive pricing balanced with quality assurance and regulatory transparency.
• Traceability and documentation: Complete documentation ensures regulatory compliance during audits.

Regulatory and Quality Standards

API suppliers for Tetrahydrozoline hydrochloride should possess certifications such as:

• WHO-GMP certification
• ISO 9001 quality management
• FDA approval (for U.S. markets)
• EDQM certification (European markets)

Compliance with pharmacopeial standards is critical, especially for APIs destined for regulated markets. Suppliers should also provide comprehensive analytical data, including HPLC purity profiles, residual solvent analysis (per ICH Q3C), and microbial limits.

Market Trends and Future Outlook

The Tetrahydrozoline hydrochloride API market is expected to grow modestly owing to an increase in global OTC ophthalmic and nasal decongestant products. Advances in manufacturing technology and quality control are likely to enhance API purity and reduce costs, broadening market accessibility.

Emerging regions with expanding healthcare infrastructure, notably Southeast Asia and Latin America, may see increased API sourcing from local or regional producers to meet rising demand.

R&D activities focused on novel delivery systems and formulations might influence future API specifications, emphasizing purity and stability. Additionally, stricter regulatory scrutiny globally will necessitate enhanced quality assurance measures from API suppliers.

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Key Takeaways

• Global supplier diversity facilitates reliable sourcing of Tetrahydrozoline hydrochloride, with China and India being primary manufacturing hubs.

• Regulatory compliance and quality assurance are non-negotiable, necessitating suppliers with robust certifications and comprehensive analytical data.

• Strategic supplier evaluation should encompass production capacity, supply reliability, regulatory history, and pricing to mitigate risks.

• Emerging markets present new opportunities for API sourcing, especially as formulations expand and regulatory landscapes evolve.

• Ongoing technological advances will enhance API quality, reduce costs, and expand supply chain resilience.

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FAQs

1. What are the primary regulatory considerations when sourcing Tetrahydrozoline hydrochloride?
Manufacturers must ensure API suppliers hold GMP certifications, comply with pharmacopeial standards (USP, EP, JP), and maintain proper documentation such as Certificates of Analysis and registration dossiers. Regulatory adherence minimizes approval delays and assures product safety.

2. How can I verify the quality of Tetrahydrozoline hydrochloride from a supplier?
Request detailed analytical data, including purity profiles, residual solvent tests, microbial limits, and impurity spectra. Conduct audits or third-party testing if necessary. A reputable supplier provides comprehensive documentation and is transparent about their quality processes.

3. Are there specific challenges associated with sourcing Tetrahydrozoline hydrochloride?
Limited number of high-quality, GMP-certified suppliers can lead to supply constraints. Variability in purity levels or impurities among suppliers might affect product efficacy. Regulatory hurdles also pose risks if suppliers lack necessary certifications.

4. What are the typical lead times for bulk Tetrahydrozoline hydrochloride?
Lead times vary based on supplier location, order volume, and regulatory approvals but generally range from 4 to 12 weeks. Early planning and clear communication with suppliers are crucial to avoid supply disruptions.

5. How is the market for Tetrahydrozoline hydrochloride expected to evolve?
Market growth is steady, driven by OTC product demand. Quality standards and regulatory oversight will continue to influence sourcing options. Investments in manufacturing technology and quality infrastructure will further improve supply reliability.

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References

1. [1] U.S. Pharmacopeia (USP). "Tetrahydrozoline Hydrochloride Monograph."
2. [2] European Pharmacopoeia (EP). "Tetrahydrozoline Hydrochloride Monograph."
3. [3] Global API Market Report 2022-2027, MarketsandMarkets.
4. [4] WHO Good Manufacturing Practices Certification Database.
5. [5] Company websites and publicly available API supplier certifications.

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The information in this report aims to guide stakeholders in making informed procurement and supply chain decisions for Tetrahydrozoline hydrochloride API, emphasizing quality, regulatory compliance, and market dynamics.