Bulk Pharmaceutical API Sources for NEOTRIZINE

Bulk Pharmaceutical API Sources for NEOTRIZINE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jhiHb@LBdFB@AFRREQQII[Z][ru@@@D@@@
Sigma-Aldrich		S8626_SIGMA
Hangzhou Trylead Chemical Technology		TL80073596
NovoSeek		5215
Vitas-M Laboratory		STK317797
MP Biomedicals		102983
TCI (Tokyo Chemical Industry)		S0579

Bulk Active Pharmaceutical Ingredient (API) Sources for: NEOTRIZINE

Last updated: July 30, 2025

---

Introduction

Neotrizine, a trade name for the antihistamine drug Hydroxyzine, is widely used to treat anxiety, nausea, allergies, and sleep disorders. Hydroxyzine, as an active pharmaceutical ingredient (API), is produced through complex chemical synthesis processes and sourced globally. The robustness of supply chains for neotrizine’s API significantly influences drug availability, pricing, and regulatory compliance. This article details the established sources for bulk Hydroxyzine API, evaluates their significance within the global pharmaceutical supply, and discusses implications for stakeholders involved in pharmaceutical manufacturing, distribution, and regulation.

---

Overview of Hydroxyzine API Manufacturing

Hydroxyzine API is synthesized through multi-step chemical synthesis involving key intermediates. The manufacturing process demands high-quality chemicals, stringent regulatory oversight, and advanced production capabilities to ensure purity, potency, and compliance with pharmacopeial standards such as the United States Pharmacopeia (USP) and European Pharmacopoeia (EP).

Major API producers have invested heavily in cGMP-compliant facilities. These manufacturers often cater to large-scale pharmaceutical firms or generic drug producers. The supply chain for Hydroxyzine API encompasses both established Western pharmaceutical companies and emerging API producers primarily based in Asia.

---

Leading Sources of Hydroxyzine API

1. Indian API Manufacturers

India commands a principal share in the production of Hydroxyzine API, owing to its cost-effective manufacturing ecosystem, robust regulatory environment (drug approvals from the Central Drugs Standard Control Organization), and extensive export networks.

Key Players:

• Granules India: A prominent producer offering bulk Hydroxyzine API compliant with international standards. Established in 1984, Granules India has a diversified portfolio of APIs and intermediates, with export markets spanning North America, Europe, and Asia. Their facilities adhere to cGMP standards and have received approvals from agencies such as the US FDA.

• Hetero Labs: Known for its large-scale pharmaceutical APIs, Hetero Labs supplies Hydroxyzine API manufactured in facilities approved by US FDA, EMA, and other deviation-sensitive regulators. Their production emphasizes high purity and consistency.

• Aurobindo Pharma: A significant player with extensive API manufacturing capabilities. Aurobindo’s Hydroxyzine API aligns with international quality standards, supporting the global generics market.

Advantages and Challenges:

• Cost-efficient manufacturing
• Access to vast production capacity
• Regulatory hurdles for some markets, especially due to accreditation differences

2. Chinese API Manufacturers

China hosts numerous API producers with significant production capacity for Hydroxyzine, driven by a large chemical manufacturing base.

Notable Companies:

• LeadTech Pharmaceutical: Specializes in APIs for antihistamines, including Hydroxyzine, with compliance certifications for US, EU, and Japanese markets.

• Kanglong Chemical: Offers Hydroxyzine API with competitive pricing, although regulatory transparency can vary, creating challenges for importation into some jurisdictions.

Market Dynamics:

Chinese API suppliers benefit from economies of scale but face increasing scrutiny over quality control and regulatory compliance, prompting many companies to seek foreign validation, including US FDA approvals.

3. European and North American API Suppliers

While fewer in number, some European and North American companies manufacture Hydroxyzine API primarily for regional markets or as part of specialty formulations.

• Lannett Company, Eagle Pharmaceuticals: Focused more on finished drug products, but some suppliers maintain API manufacturing for specific regional supply needs.

• US-based Contract Manufacturing Organizations (CMOs): Several CMOs in the US produce Hydroxyzine API for domestic use, complying with strict regulatory standards. These include PACIRA Pharmaceuticals and CordenPharma.

---

Regulatory and Quality Considerations

The global API supply for Hydroxyzine must meet strict regulatory standards. Manufacturers exporting to developed markets typically obtain approvals such as:

• FDA Approvals: Necessary for US market supply, involving rigorous inspections and documentation.
• EMA Certification: Required to supply within the European Union.
• JP Pharmacopeia Compliance: Necessary for Japanese markets.

Third-party certifications, including ISO 9001 and cGMP, bolster supplier reliability. Manufacturers with such certifications are generally prioritized by pharmaceutical companies due to reduced regulatory risk.

---

Supply Chain and Market Trends

The trend towards consolidating API manufacturing in Asia aligns with the increasing demand for affordable antihistamines globally. The COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting pharmaceutical firms to diversify API sources. Additionally, regulatory tightening and quality assurance are influencing procurement strategies, favoring reputable suppliers with established compliance histories.

Emerging Chinese and Indian API producers seeking clearance for US FDA approval are investing in modernization of facilities, which may expand supply security and quality for Hydroxyzine API in the future.

---

Implications for Pharmaceutical Stakeholders

• Manufacturers must balance cost with quality, sourcing API from approved, compliant API manufacturers to mitigate regulatory risks.
• Distributors should prioritize suppliers with validated quality systems, detailed Certificates of Analysis (CoA), and traceability mechanisms.
• Regulators focus on continuous oversight to ensure API sources comply with current Good Manufacturing Practices (cGMP).
• Investors and Business Strategists should monitor geopolitical influences, such as trade policies and tariffs, impacting API sourcing.

---

Key Challenges in API Sourcing

• Variability in API quality and purity across different regions
• Regulatory hurdles when importing APIs from developing regions
• Supply chain disruptions due to geopolitical or logistical issues
• The increasing pressure for transparent sourcing and quality documentation

---

Conclusion

The global Hydroxyzine API market hinges on diverse sources, predominantly from India and China, with supplementary supply from Europe and North America. Ensuring regency-approved, high-quality sourcing practices remains critical for pharmaceutical companies manufacturing neotrizine products. As regulatory landscapes evolve, suppliers seeking to expand their global footprint must couple competitive pricing with demonstrated regulatory compliance to meet international standards.

---

Key Takeaways

• India and China dominate Hydroxyzine API production, offering cost advantages but requiring thorough quality validation.
• Reputable API suppliers with FDA, EMA, or equivalent approvals provide regulatory certainty and mitigate supply risks.
• Diversification of API sources is increasingly vital amid geopolitical uncertainties and pandemic-related disruptions.
• Suppliers must demonstrate compliance with cGMP, ISO, and pharmacopeial standards to sustain market access.
• Stakeholders should prioritize transparency, documentation, and regulatory certification in their sourcing strategies.

---

FAQs

1. What are the main regions producing Hydroxyzine API?
India and China are the primary global producers, with European and North American suppliers primarily serving regional markets.

2. How can manufacturers ensure the quality of Hydroxyzine API?
By sourcing from suppliers with valid cGMP certifications, regulatory approvals (FDA, EMA), and comprehensive Certificates of Analysis.

3. Are Chinese Hydroxyzine API producers reliable?
Many Chinese manufacturers are capable of producing quality API, but variability exists. Due diligence, including audits and regulatory approval verification, is essential.

4. What regulatory considerations apply to sourcing Hydroxyzine API?
Manufacturers must verify that API suppliers meet local and international standards, including cGMP compliance, and hold necessary approvals from regulatory bodies like the FDA and EMA.

5. How is API sourcing evolving in response to global demands?
There's a trend towards diversification, increased compliance standards, and investment in quality infrastructure to ensure supply chain resilience and meet regulatory scrutiny.

---

References

1. [1] U.S. Food and Drug Administration (FDA). cGMP Regulations for Finished Pharmaceuticals.
2. [2] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice.
3. [3] Pharmaceutical Technology. “Global API Manufacturing Trends.”
4. [4] Indian Pharmaceutical Alliance. “API Manufacturing in India.”
5. [5] Chinese Pharmaceutical Industry Association. “API Production Overview.”