Suppliers and packagers for TROPICAMIDE

TROPICAMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	040067	ANDA	Bausch & Lomb Incorporated	24208-590-64	1 BOTTLE, DROPPER in 1 CARTON (24208-590-64) / 15 mL in 1 BOTTLE, DROPPER	1994-07-27
Bausch And Lomb	TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	040064	ANDA	Bausch & Lomb Incorporated	24208-585-59	1 BOTTLE, DROPPER in 1 CARTON (24208-585-59) / 2 mL in 1 BOTTLE, DROPPER	1994-07-27
Bausch And Lomb	TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	040064	ANDA	Bausch & Lomb Incorporated	24208-585-64	1 BOTTLE, DROPPER in 1 CARTON (24208-585-64) / 15 mL in 1 BOTTLE, DROPPER	1994-07-27
Somerset Theraps Llc	TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	207524	ANDA	Somerset Therapeutics, LLC	70069-121-01	1 BOTTLE in 1 CARTON (70069-121-01) / 15 mL in 1 BOTTLE	2019-12-12

Suppliers for the Pharmaceutical Drug: Tropicamide

Last updated: July 27, 2025

Introduction

Tropicamide is a mydriatic and cycloplegic agent widely used in ophthalmology to dilate pupils during eye examinations. Its rapid onset and short duration make it a preferred choice for quantitative diagnostic procedures. As demand for ophthalmic diagnostics grows globally, the supply chain for tropicamide remains a critical aspect for pharmaceutical companies, healthcare providers, and ancillary suppliers. This article examines the primary suppliers of tropicamide, analyzing their manufacturing capacities, geographic distribution, regulatory status, and market positioning to provide a comprehensive overview for stakeholders seeking reliable sourcing options.

Manufacturers and Suppliers of Tropicamide

1. Major Global Manufacturers

Several pharmaceutical companies are recognized for producing tropicamide at scale, with some being the original developers and others licensed producers. Notable among them are:

• Sandoz (Novartis Group): Historically a leading manufacturer of tropicamide, Sandoz supplies both ophthalmic and diagnostic formulations globally. Their production facilities are located in Europe and North America, meeting stringent regulatory standards such as the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) approvals.

• Alcon (Novartis Division): As a subsidiary specializing in eye care devices and pharmaceuticals, Alcon manufactures tropicamide formulations aimed at both clinical and diagnostic use. Their products are distributed worldwide, especially in North America, Europe, and Asia-Pacific.

• Abbott Laboratories: Produces tropicamide as part of their ophthalmic diagnostic portfolio, with manufacturing sites across North America and Europe. Abbott’s robust distribution network ensures widespread availability.

• Bausch + Lomb: A major player in eye health, Bausch + Lomb manufactures tropicamide-containing ophthalmic solutions for diagnostic purposes, with production primarily based in the U.S. and Europe.

2. Regional and Contract Manufacturers

In addition to the branded pharmaceutical giants, several regional manufacturers and contract manufacturing organizations (CMOs) also produce tropicamide, often under licensing agreements or generics branding:

• Lepu Medical: Based in China, Lepu supplies ophthalmic diagnostic agents, including tropicamide, primarily targeting Asian markets but increasingly expanding globally.

• Sino Biopharmaceutical: Also operating within China, this company manufactures ophthalmic agents, including tropicamide, often serving local health systems and export markets.

• Almeco: A CMO that specializes in sterile ophthalmic solutions, producing tropicamide under various private labels and for international clients.

3. Suppliers of Active Pharmaceutical Ingredient (API)

Tropicamide's manufacturing begins with its active pharmaceutical ingredient. Several specialty chemical producers supply high-purity tropicamide API:

• Nanjing Pharmaceutical Factory: Located in China, they produce API compliant with international standards, supplying both branded and generic manufacturers.

• HDC Healthcare: Based in India, this company supplies tropicamide API internationally, often catering to the generics market.

• Anhui Biochem Pharmaceutical Co.: A Chinese API producer with capacity for tropicamide, adhering to Good Manufacturing Practices (GMP).

The API supply chain is characterized by intense competition among Asian producers, driven by cost advantages and increasing regulatory standards.

Regulatory and Quality Considerations

Quality assurance remains paramount for suppliers of tropicamide. Regulatory approvals from authorities such as the FDA, EMA, and Japan’s Pharmaceutical and Medical Device Act (PMDA) govern the manufacturing and distribution processes. Suppliers compliant with these standards ensure product consistency, sterility, and efficacy, essential for ophthalmic agents.

Certifications and Compliance

Most reputable suppliers maintain certifications such as:

• GMP (Good Manufacturing Practices)
• ISO 9001/13485
• CE marking (Europe)
• FDA approval or clearance for marketed formulations

These certifications verify adherence to quality standards critical in the ophthalmic pharmaceutical sector.

Market Dynamics and Supplier Strategies

The tropicamide supply landscape reflects broader trends within ophthalmic pharmaceuticals:

• Consolidation: Leading global suppliers have pursued strategic mergers to strengthen their R&D, manufacturing infrastructure, and distribution channels.

• Localization: Growing markets in Asia-Pacific and Latin America prompt regional manufacturing, reducing supply chain disruptions and import dependencies.

• Generic Expansion: The expiration of patent protections for many ophthalmic agents fuels growth in generic tropicamide production, increasing supplier diversity.

• Supply Chain Resilience: Disruptions due to geopolitical tensions, pandemics, or raw material shortages have prompted suppliers to diversify sources and establish backup partnerships.

Challenges and Opportunities

Challenges

• Raw Material Accessibility: Supply bottlenecks in API, especially from China and India, can disrupt formulation manufacturing.
• Regulatory Hurdles: Variations in regional drug approval processes necessitate compliance strategies tailored for different markets.
• Pricing Pressures: Competitive generic markets exert downward pricing, influencing supplier profit margins and investment in quality enhancements.

Opportunities

• Innovation in Formulation: Developing sustained-release or combination formulations can create new market niches.
• Regional Production Expansion: Localization plans can mitigate geopolitical risks and meet local regulatory requirements.
• Strategic Partnerships: Collaborations between API producers and final drug manufacturers enhance supply security.

Conclusion

The global supply of tropicamide hinges on a combination of established pharmaceutical companies and regional manufacturers, with API producers predominantly concentrated in Asia. Ensuring reliable sourcing involves evaluating suppliers' regulatory status, manufacturing capacity, and compliance with quality standards. The evolving landscape favors diversification and strategic alliances, with opportunities rooted in innovative formulation development and regional manufacturing expansion. Stakeholders investing in or procuring tropicamide must navigate regulatory complexities and geopolitical considerations to maintain uninterrupted supply chains.

Key Takeaways

• Leading global suppliers include Sandoz, Alcon, Abbott, and Bausch + Lomb; regional markets also rely on Asian manufacturers such as Lepu Medical and Sino Biopharmaceutical.
• API sourcing is primarily driven by Chinese and Indian producers, requiring rigorous quality and compliance assessments.
• Regulatory certifications like GMP and CE marking are vital for ensuring product quality and market access across regions.
• Supply chain resilience depends on diversification strategies amid raw material shortages and geopolitical risks.
• Innovation in ophthalmic formulations presents growth opportunities within the tropicamide market.

FAQs

1. Who are the main manufacturers of tropicamide ophthalmic solutions?
Major players include Sandoz, Alcon, Abbott Laboratories, and Bausch + Lomb, with regional manufacturers supplying secondary markets.

2. Where is the active pharmaceutical ingredient (API) for tropicamide primarily produced?
API production is predominantly located in China and India, with companies like Nanjing Pharmaceutical Factory and HDC Healthcare leading supply.

3. What quality standards must suppliers of tropicamide meet?
Suppliers should adhere to GMP, ISO standards, and possess regulatory approvals such as FDA clearance and CE marking to ensure safety and efficacy.

4. How does market demand influence tropicamide supply strategies?
Growing demand, especially for diagnostic applications, prompts manufacturers to expand capacity, establish regional facilities, and seek diversified sourcing options.

5. What are future growth prospects for the tropicamide market?
Development of innovative formulations, regional manufacturing expansion, and increasing ophthalmic diagnostics worldwide suggest steady growth and supply opportunities.

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Sources:
[1] Ophthalmic pharmaceuticals market analysis (2023).
[2] Global API manufacturers directory (2023).
[3] Regulatory standards for ophthalmic drugs (EMA, FDA, 2023).
[4] Industry reports on Asian pharmaceutical manufacturing capacity (2022).