Suppliers and packagers for generic pharmaceutical drug: DYCLONINE HYDROCHLORIDE

DYCLONINE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Septodont	DYCLOPRO	dyclonine hydrochloride	SOLUTION;TOPICAL	200480	ANDA	Septodont Inc	0362-3971-05	1 BOTTLE in 1 BOTTLE (0362-3971-05) / 30 mL in 1 BOTTLE	2019-09-01

Suppliers for the Pharmaceutical Drug: Dyclonine Hydrochloride

Last updated: August 4, 2025

Introduction

Dyclonine hydrochloride is a local anesthetic first developed in the 1950s, widely used for its numbing effects in sore throat lozenges, mouthwashes, and topical anesthetic formulations. Recognized for its long-standing safety profile and effectiveness, dyclonine is an integral part of various over-the-counter (OTC) and prescription products. The pharmaceutical industry's supply chain for dyclonine hydrochloride involves multiple drug manufacturers, active pharmaceutical ingredient (API) suppliers, and contract manufacturing organizations (CMOs). Understanding the landscape of suppliers is crucial for stakeholders in drug development, procurement, and strategic planning.

Overview of Dyclonine Hydrochloride Manufacturing

Dyclonine hydrochloride is synthesized through a multi-step chemical process involving the preparation of the core aromatic amino compound, subsequent halogenation, and quaternization to yield the final hydrochloride salt. Its manufacturing requires specialized chemical expertise, strict quality controls, and adherence to Good Manufacturing Practices (GMP).

Industry players range from large multinational bulk API suppliers to smaller specialty manufacturers. Several factors influence the selection of suppliers, including chemical purity, supply stability, regulatory compliance, and cost competitiveness.

Major API Suppliers for Dyclonine Hydrochloride

1. International API Producers

A. Sinphar Pharmaceutical Co., Ltd. (Taiwan)
Sinphar is a recognized supplier of various APIs, including dyclonine hydrochloride. The company supplies to both domestic and international clients, emphasizing quality control and GMP compliance. Sinphar’s strategic manufacturing facilities enable consistent supply for OTC pharmaceuticals and prescription forms.

B. Zhejiang Honghua Pharmaceutical Co., Ltd. (China)
Based in China, Zhejiang Honghua specializes in synthesizing quaternary amine compounds, including dyclonine hydrochloride. Their manufacturing adheres to international quality standards, and they serve markets across Asia, North America, and Europe.

C. Zhejiang Medicine Co., Ltd. (China)
This company is another significant Chinese API producer offering dyclonine hydrochloride. Zhejiang Medicine has expanded its portfolio with high-purity APIs, focusing on meeting stringent regulatory requirements worldwide.

D. Megapharm (Israel)
Megapharm offers an array of pharmaceutical APIs, including some local anesthetics. While primarily known for other APIs, the company has in recent years increased focus on niche anesthetic compounds, possibly including dyclonine hydrochloride.

2. Regional and Specialty Suppliers

A. HUBEI FORERUN BIO-TECH CO., LTD. (China)
This biotech-oriented firm supplies a variety of APIs, including local anesthetics, with a reputation for high-quality chemical synthesis and global distribution capabilities.

B. Puruo Pharmaceutical (China)
A smaller, specialized manufacturer focusing on niche APIs, including quaternary ammonium compounds like dyclonine hydrochloride.

C. Contract Manufacturers and Custom Synthesis Providers
Several CMOs provide custom synthesis of dyclonine hydrochloride for pharmaceutical companies requiring tailored formulations or large-scale batch production. Notable companies include:

• Patelমান Pharmachem (India)
• CordenPharma (Europe/US)
• Bachem (Switzerland)

These organizations often serve as strategic partners to ensure supply chain resilience.

Market Dynamics and Supply Chain Considerations

• Geographical Concentration: The bulk of dyclonine hydrochloride production centers in Asia, mainly China and Taiwan, due to lower manufacturing costs and established chemical industries.

• Regulatory Compliance: Suppliers must comply with international standards such as GMP, and many have certifications for exports to the US (FDA approved), Europe (EMA-approved), and other markets.

• Supply Chain Risks: Dependence on regional API providers poses risks related to geopolitical issues, manufacturing disruptions, and regulatory changes. Diversification across multiple suppliers and regions minimizes potential supply chain interruptions.

• Price Sensitivity: Market pricing for dyclonine hydrochloride varies based on purity, batch size, and supplier specifications. Large-scale pharmaceutical companies often negotiate long-term contracts with key suppliers for cost stability.

Emerging Trends and Future Outlook

• Vertical Integration: Some pharmaceutical companies are investing in establishing in-house API manufacturing capabilities to reduce reliance on external suppliers.

• Regulatory Stringency: Stricter quality and compliance standards are shaping supplier eligibility, favoring those with robust GMP certifications and proven regulatory track records.

• Technological Advancements: Innovations in chemical synthesis and process optimization are enabling new suppliers to enter the market with high-quality dyclonine hydrochloride.

• Supply Chain Resilience: The COVID-19 pandemic underscored the importance of diversified sourcing strategies, prompting companies to develop multi-regional supplier networks.

Regulatory and Procurement Considerations

• Supplier Qualification: Procurement teams must verify suppliers’ GMP certifications, audit reports, and regulatory approvals, especially when importing from China or other regions with varying quality standards.

• Quality Assurance and Testing: Ensuring batch-to-batch consistency and high chemical purity requires rigorous testing and documentation, critical for regulatory submissions and product efficacy.

• Intellectual Property: As dyclonine hydrochloride is an off-patent compound, generic suppliers can produce compliant versions, increasing market competition and procurement options.

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Key Takeaways

• The primary suppliers of dyclonine hydrochloride are predominantly located in China and Taiwan, leveraging cost advantages and established chemical manufacturing infrastructure.

• Major players include Sinphar Pharmaceutical, Zhejiang Honghua Pharmaceutical, and Zhejiang Medicine, all holding extensive regulatory compliance credentials.

• Contract manufacturing organizations (CMOs) provide bespoke synthesis options, offering flexibility and supply chain resilience.

• Industry trends emphasize diversification, regulatory adherence, technological advancements, and vertical integration to ensure steady supply.

• Due diligence in supplier qualification, quality testing, and regulatory validation remains critical for pharmaceutical companies sourcing dyclonine hydrochloride.

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FAQs

1. Is dyclonine hydrochloride available from domestic US suppliers?
Currently, most dyclonine hydrochloride is imported from Asian manufacturers, primarily China and Taiwan. Few domestic US APIs produce dyclonine at scale, making international suppliers the primary source.

2. What quality standards should I verify in a dyclonine hydrochloride supplier?
Verify GMP certification, batch certification, purity levels (typically ≥98%), and compliance with USP or EP standards. Regulatory approvals from agencies like the FDA or EMA add confidence.

3. Are there new entrants in the dyclonine hydrochloride supply chain?
Yes. Advancements in chemical synthesis and increasing demand have led to new specialized manufacturers in Asia offering high-quality dyclonine hydrochloride, though market dominance remains with established suppliers.

4. How does supply chain diversification mitigate risks for dyclonine hydrochloride procurement?
Diversifying sources across multiple regions and suppliers reduces dependency on a single manufacturer, helping prevent disruptions due to geopolitical issues, production halts, or quality problems.

5. What are the key factors influencing the selection of a dyclonine hydrochloride supplier?
Quality assurance, regulatory compliance, supply capacity, price competitiveness, lead times, and the supplier’s track record for consistent quality are essential considerations.

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References

1. U.S. Food and Drug Administration. (2022). GMP Guidelines for APIs.
2. European Medicines Agency. (2021). Guidelines on Good Manufacturing Practices.
3. Industry reports on API manufacturing in Asia. (2022).
4. Company websites and technical datasheets.
5. Market intelligence on pharmaceutical active ingredient supply chains.