Bulk Pharmaceutical API Sources for tolazoline hydrochloride

Bulk Pharmaceutical API Sources for tolazoline hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		Hkm@`HHHaAf_eR[SZj@B@@@
NovoSeek		6048
MP Biomedicals		156932
MolPort		MolPort-003-666-292
ISpharm		I14-10561
AAA Chemistry		AR-1L1792
NIH Clinical Collection		SAM002589935

Bulk Active Pharmaceutical Ingredient (API) Sources for Tolazoline Hydrochloride

Last updated: July 29, 2025

Introduction

Tolazoline hydrochloride is a well-established pharmaceutical agent primarily used as a vasodilator, notably in the treatment of conditions such as persistent pulmonary hypertension of the newborn (PPHN), and as an antagonist in certain drug overdoses. Given its clinical importance, the availability of high-quality bulk API sources is essential for pharmaceutical manufacturing. This report examines the current landscape of API suppliers for tolazoline hydrochloride—covering key geographical sources, manufacturing standards, and supply chain considerations—aimed at helping pharmaceutical companies, distributors, and procurement professionals make informed sourcing decisions.

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Understanding Tolazoline Hydrochloride: Chemical Profile

Tolazoline hydrochloride, chemically known as N-[2-(2-Benzyl-2,3-dihydro-1H-pyrazol-1-yl)ethyl]-2-hydroxy-2,3-dihydro-1H-phenoxazine hydrochloride, is a vasoactive agent classified as a derivative of phenoxazine. It exerts its vasodilatory effect primarily by adrenergic receptor antagonism. Its synthesis involves multiple chemical reactions, demanding stringent process controls to ensure purity and stability—attributes that are central to API source evaluation.

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Global API Manufacturing Landscape

1. Asia-Pacific Region

Dominant Players: India and China dominate the production of tolazoline hydrochloride API, owing to their extensive chemical manufacturing infrastructure and competitive cost structure.

• Indian API Manufacturers: India hosts several GMP-certified API producers capable of supplying tolazoline hydrochloride at scale. Notable among them are Siddharth Healthcare, Neelchem, and Aurobindo Pharma, which are experienced in complex organic syntheses and quality management aligned with international standards. These manufacturers often possess WHO-GMP or EU-GMP certifications.[1]

• Chinese API Producers: China’s API industry has a significant footprint in the production of vasodilators, including tolazoline hydrochloride. Companies like Zhejiang Hisun Pharmaceutical Co. and North China Pharmaceutical Group Corp. have facilities capable of manufacturing APIs compliant with global standards, capable of meeting both regulatory and bulk requirements.[2]

Advantages: Competitive pricing, large-scale production capacity, and access to strict quality control measures.

Challenges: Variability in regulatory compliance, potential supply chain disruptions, and concerns regarding intellectual property rights.

2. European and North American Suppliers

Although the Asia-Pacific remains dominant, some European and North American companies specialize in high-purity APIs for niche markets.

• European API Suppliers: Organizations like Baxter International and TEVA Pharmaceuticals may produce tolazoline hydrochloride under strict GMP conditions for regional markets. Their focus on quality assurance and regulatory compliance makes them suitable for companies prioritizing stringent quality standards.

• North American API Manufacturers: Firms such as Viking Pharmaceuticals and Basilea Pharmaceutica have capabilities for API manufacturing, including bespoke synthesis and custom manufacturing services. However, these tend to serve specialized or low-volume needs due to higher costs.[3]

Advantages: Stringent regulatory oversight, high-quality standards, proven traceability.

Challenges: Higher costs and limited capacity compared to Asian producers.

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Evaluating API Suppliers: Quality and Regulatory Considerations

• GMP Certification: Ensures manufacturing processes meet established quality standards, vital for regulatory approval in target markets.

• Documentation and Traceability: Suppliers should provide comprehensive documentation, including Certificates of Analysis (CoA), full batch records, and stability data.

• Purity and Impurity Profile: The API must adhere to pharmacopoeial specifications, with impurities minimized per ICH guidelines.

• Regulatory Approvals: Verify supplier registration status with FDA, EMA, or corresponding authorities, especially for markets with strict compliance requirements.

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Supply Chain and Reliability Factors

• Production Capacity: Large-scale manufacturers with diversified portfolios tend to be more reliable in supply continuity.

• Lead Times: Response times vary; established suppliers typically offer shorter lead times and better logistical support.

• Price and Payment Terms: Competitive pricing is essential, but should not compromise quality. Flexible payment terms and volume discounts are advantageous.

• Import Regulations: Countries' importation policies and tariffs influence procurement strategy.

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Emerging and Alternative Sources

Growing demand for biosimilar and generic APIs has spurred manufacturing diversification, including:

• Emerging Indian and Chinese startups investing in scalable manufacturing processes for tolazoline hydrochloride to increase supply resilience.

• Contract manufacturing organizations (CMOs): Offering custom synthesis and outsourcing options, easing capacity constraints for pharmaceutical companies.

However, these sources require rigorous due diligence to verify compliance and quality standards.

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Regulatory and Quality Trends

Pharmaceutical companies are increasingly emphasizing Regulatory Intelligence (RI) to ensure API sources align with evolving standards:

• ICH Q7 guidelines for API good manufacturing practices.

• Scrutiny of DPRs (Detailed Product Reports): To validate API quality.

• Source Verification: Critical for minimizing regulatory risks and ensuring consistent product efficacy.

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Conclusion

The procurement landscape for tolazoline hydrochloride API is predominantly characterized by robust manufacturing hubs in India and China, supported by high-standard suppliers in Europe and North America. Strategic sourcing should prioritize suppliers with proven GMP compliance, documented quality control, and reliable supply chains. While cost remains a significant factor, maintaining quality and regulatory adherence is paramount to ensuring safe and effective pharmaceutical products.

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Key Takeaways

• Asia, especially India and China, dominates tolazoline hydrochloride API manufacturing, offering substantial capacity and cost advantages.

• European and North American suppliers provide high-standard APIs suitable for markets with stringent regulatory requirements.

• Rigorous supplier evaluation—including GMP certification, documentation, impurity profiles, and compliance—is critical to mitigate supply and quality risks.

• Supply chain robustness depends on supplier capacity, lead times, and geopolitical/regulatory factors.

• Emerging manufacturers and CMOs present opportunities for diversification but require thorough due diligence.

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FAQs

1. What are the key quality indicators when sourcing tolazoline hydrochloride API?
High-quality APIs should meet pharmacopoeial standards (USP, EP, JP), with verified purity (>98%), minimal impurities, and comprehensive documentation including CoAs, stability data, and GMP certifications.

2. How does geographic origin influence API quality and regulatory acceptance?
While Asian producers offer cost-effective solutions, European and North American suppliers often provide APIs with more rigorous regulatory documentation, which can facilitate faster approval and market access in strict jurisdictions.

3. What are the typical lead times for tolazoline hydrochloride API supply?
Lead times vary; established GMP-certified manufacturers in India and China typically deliver within 4-8 weeks, depending on order volume, regulatory clearance, and logistics considerations.

4. Are there any regulatory restrictions on importing tolazoline hydrochloride API?
Regulatory restrictions vary by country. Importers must ensure API suppliers comply with local GMP and import regulations, including registration and licensing requirements from agencies like the FDA or EMA.

5. Can custom synthesis be arranged for tolazoline hydrochloride API?
Yes. Contract manufacturing organizations offer custom synthesis services, enabling companies to tailor specifications, purity, and packaging, provided that manufacturers meet regulatory and quality standards.

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Sources

[1] Pharmacopoeial and industry standards for API manufacturing in India.
[2] Chinese API industry capabilities and certifications.
[3] European and North American API suppliers’ regulatory profiles.