PROPARACAINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon Labs Inc	ALCAINE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	080027	ANDA	Alcon Laboratories, Inc.	0998-0016-15	1 BOTTLE in 1 CARTON (0998-0016-15) / 15 mL in 1 BOTTLE	1973-10-19
Alcon Labs Inc	ALCAINE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	080027	ANDA	Sandoz Inc.	61314-016-01	1 BOTTLE in 1 CARTON (61314-016-01) / 15 mL in 1 BOTTLE	2000-06-05
Alcon Labs Inc	ALCAINE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	080027	ANDA	NuCare Pharmaceuticals,Inc.	68071-5139-5	15 mL in 1 BOTTLE (68071-5139-5)	1973-10-19
Alcon Labs Inc	ALCAINE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	080027	ANDA	REMEDYREPACK INC.	70518-3408-0	1 BOTTLE in 1 CARTON (70518-3408-0) / 15 mL in 1 BOTTLE	2022-04-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Proparacaine Hydrochloride is a local anesthetic primarily used in ophthalmology to numb the surface of the eye prior to diagnostic procedures, surgery, or irrigation. Its rapid onset, short duration of action, and safety profile make it a preferred agent in clinical settings. The global supply chain for Proparacaine Hydrochloride involves a diverse network of suppliers ranging from active pharmaceutical ingredient (API) manufacturers to finished drug product manufacturers. Understanding these suppliers is critical for stakeholders in the pharmaceutical and healthcare sectors, including manufacturers, distributors, and regulators, aiming for reliable sourcing and supply chain resilience.

Overview of the Global Supply Chain for Proparacaine Hydrochloride

The supply chain for Proparacaine Hydrochloride encompasses several core components:

API Manufacturers: Companies responsible for producing the active pharmaceutical ingredient, Proparacaine Hydrochloride.
Formulation and Finished Product Manufacturers: Entities that formulate the API into eye drops or solutions suitable for medical use.
Distributors and Wholesalers: Intermediaries distributing the finished products globally.
Regulatory Authorities: Agencies that regulate manufacturing standards, ensuring quality and safety.

The global landscape features manufacturing hubs primarily in Asia, notably India and China, which dominate the production of ophthalmic anesthetics owing to cost-effectiveness, scale, and regulatory compatibility.

Major Suppliers of Proparacaine Hydrochloride API

1. Indian Manufacturers

India’s pharmaceutical industry is the largest supplier of ophthalmic anesthetic APIs, including Proparacaine Hydrochloride. This is attributable to its extensive manufacturing infrastructure, cost advantages, and compliance with global Good Manufacturing Practices (GMP).

Sun Pharmaceutical Industries Ltd
A leading Indian pharmaceutical firm with capabilities in API production, Sun Pharma supplies Proparacaine Hydrochloride to numerous international markets. Their API manufacturing facilities adhere to stringent quality standards, making them a reliable source across various regions.
Aarti Drugs Ltd
Aarti Drugs specializes in the synthesis of anesthetic API compounds, including Proparacaine Hydrochloride. Their expertise in chemical synthesis and global export track record make them notable suppliers.
DB chemicals
A smaller but significant producer, DB Chemicals supplies APIs globally, including ophthalmic anesthetics like Proparacaine Hydrochloride, emphasizing quality control and competitive pricing.

2. Chinese API Manufacturers

China’s pharmaceutical industry is a vital player, providing a broad range of APIs.

/Note: Some Chinese companies may operate under less transparent regulatory oversight; due diligence is essential./

Hainan Yew Pharmaceutical Co., Ltd.
Specializes in ophthalmic APIs, including Proparacaine Hydrochloride, with export licenses to multiple markets following compliant manufacturing standards.
Zhejiang Medicine Co., Ltd.
Their API division produces ophthalmic anesthetic compounds with certifications supporting international sales.

3. Other Asian and Global API Suppliers

While India and China dominate, other suppliers in Asia and Europe contribute to the market:

Bayer AG (Germany)
Although more focused on finished ophthalmic products, Bayer maintains some API production capabilities, potentially supplying Proparacaine Hydrochloride formulations.
Sinoform Pharmaceuticals (China)
A manufacturer of ophthalmic APIs with export experience.

Suppliers of Finished Proparacaine Hydrochloride Products

Finished pharmaceutical products are formulated and packaged for distribution. Key players include:

Alcon (Novartis AG)
A global leader in ophthalmology, Alcon produces proprietary formulations of Proparacaine-containing eye drops, manufactured under strict regulatory standards.
Allergan (AbbVie Inc.)
Offers ophthalmic anesthesia solutions, including formulations containing Proparacaine Hydrochloride, adhering to high-quality standards.
Akorn, Inc.
Provides generic ophthalmic anesthetic solutions, often sourcing APIs from global suppliers and complying with regulatory requirements.

Regional Suppliers and Market Dynamics

North America and Europe

Product manufacturing in North America and Europe predominantly relies on imported APIs, with regional companies focusing on high-margin finished formulations within tightly regulated markets. Regulatory agencies such as the FDA (USA) and EMA (Europe) enforce strict quality standards, thus vetting API suppliers accordingly.

Regulatory oversight ensures that only compliant suppliers are approved for supplying APIs and finished products in these regions. Regulatory submissions and audits serve as verification mechanisms for supplier credibility.

Asia-Pacific Region

The Asia-Pacific market accounts for the majority of global API production due to cost advantages, large manufacturing bases, and expanding healthcare infrastructure. However, regulatory oversight varies, making supplier due diligence essential for importers.

Factors Influencing Supplier Selection

Quality and Regulatory Compliance: GMP certification and compliance with WHO prequalification or equivalent are critical.
Production Capacity: Ensuring suppliers can meet global demand, especially during supply disruptions.
Price Competitiveness: Cost remains a major factor, especially for generics and bulk procurement.
Supply Chain Reliability: Proven track record for timely delivery, transparency, and stability.
Intellectual Property and Legal Considerations: Compliance with licensing agreements and patent laws.

Future Outlook and Trends

Increase in Supply Chain Diversification: To mitigate geopolitical risks and supply chain disruptions observed during global crises, buyers are seeking diversified suppliers.
Regulatory Harmonization Efforts: Initiatives like ICH guidelines aim to standardize manufacturing and quality assurance, aiding global supplier recognition.
Emergence of Contract Manufacturing: Large pharmaceutical companies increasingly outsource API production to specialized OEMs (Original Equipment Manufacturers), expanding the supplier network.

Conclusion

The global supply network for Proparacaine Hydrochloride involves a broad array of suppliers predominantly situated in India and China, with a smaller but strategic presence in Europe and North America. Ensuring supply chain resilience entails closely vetting supplier quality, regulatory compliance, and production capacity. For stakeholders seeking to secure reliable access to Proparacaine Hydrochloride, building relationships with certified manufacturers and maintaining rigorous quality assurance processes remain paramount.

Key Takeaways

Indian and Chinese manufacturers dominate the API supply landscape, necessitating diligent vendor qualification.
Regulatory compliance (GMP, WHO PQ) is non-negotiable in selecting suppliers.
Diversifying supplier bases reduces risks associated with geopolitical or supply chain disruptions.
End-users should prioritize quality and regulatory adherence over cost considerations.
Ongoing industry trends include increased regulatory harmonization and the growth of contract manufacturing services.

FAQs

1. What are the leading API manufacturers for Proparacaine Hydrochloride?
Indian companies such as Sun Pharmaceutical Industries and Aarti Drugs are among the top API suppliers, complemented by Chinese manufacturers like Zhejiang Medicine. They have established GMP-certified facilities to meet international quality standards.

2. Are there localized suppliers for Proparacaine Hydrochloride in North America or Europe?
While most APIs are imported, some regional manufacturers or finished product companies may produce proprietary formulations. However, the majority of API manufacturing occurs in Asia, with strict regulatory oversight in the importing countries ensuring quality.

3. How can buyers verify the credibility of Proparacaine Hydrochloride suppliers?
Verification through regulatory certifications (GMP, WHO prequalification), supplier audits, and supply history review are essential. Consulting third-party quality assessments and engaging with trusted distributors also enhances reliability.

4. What are the risks associated with sourcing Proparacaine Hydrochloride from Asian manufacturers?
Potential risks include variable regulatory standards, supply chain disruptions, and quality inconsistencies. Due diligence, supplier audits, and certification verification mitigate these risks.

5. What trends are shaping the future supply landscape for ophthalmic anesthetics like Proparacaine Hydrochloride?
Increasing focus on supply chain resilience, regulatory harmonization, and contract manufacturing are shaping the landscape, with a move toward diversified supplier sourcing and technological innovation in synthesis methods.

References

[1] World Health Organization. (2020). WHO Prequalification of Medicines Programme.
[2] IMS Health. (2021). Global API Market Reports.
[3] U.S. Food & Drug Administration. (2022). Guidance for Industry: Good Manufacturing Practices.
[4] Deciphering the OTC & Prescription Ophthalmic Market Dynamics, Drug Insights. (2022).
[5] PMC: "Global Ophthalmic Pharmaceutical Market Analysis," PubMed Central, 2021.

Suppliers and packagers for generic pharmaceutical drug: PROPARACAINE HYDROCHLORIDE