Suppliers and packagers for ISOPTO ATROPINE

ISOPTO ATROPINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon Labs Inc	ISOPTO ATROPINE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	208151	NDA	Alcon Laboratories, Inc.	0065-0817-01	1 BOTTLE, DROPPER in 1 CARTON (0065-0817-01) / 5 mL in 1 BOTTLE, DROPPER	2022-11-01
Alcon Labs Inc	ISOPTO ATROPINE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	208151	NDA	Alcon Laboratories, Inc.	0065-0817-02	1 BOTTLE, DROPPER in 1 CARTON (0065-0817-02) / 2 mL in 1 BOTTLE, DROPPER	2022-11-01

Suppliers for the Pharmaceutical Drug: ISOPTO ATROPINE

Introduction

Last updated: July 30, 2025

Isopto Atropine is a prescription ophthalmic solution primarily used to dilate the pupils during eye examinations or surgical procedures. Its active ingredient, atropine sulfate, is a well-established anticholinergic agent. The global demand for Isopto Atropine hinges on the supply chain robustness and the availability of high-quality raw materials and finished products. This article examines the key suppliers involved in the production and distribution of Isopto Atropine, emphasizing the supply chain dynamics, regulatory considerations, and strategic procurement insights relevant to pharmaceutical industry stakeholders.

Manufacturers of Active Pharmaceutical Ingredients (APIs)

The foundation of Isopto Atropine’s supply chain lies in the sourcing of atropine sulfate, the active pharmaceutical ingredient (API). Several specialized API manufacturers globally produce atropine sulfate with varying degrees of quality, regulatory compliance, and capacity.

1. Catalent Pharma Solutions – A leading global provider of specialty pharmaceutical manufacturing, Catalent produces atropine sulfate APIs and offers contract manufacturing services for ophthalmic products. Their extensive quality management systems ensure GMP compliance, making their APIs suitable for ophthalmic formulations.

2. Hanlim Pharmaceutical Co., Ltd. – Based in South Korea, Hanlim Pharmaceutical manufactures atropine sulfate APIs, catering predominantly to Asian markets. Their APIs meet international quality standards, and they hold multiple certifications including ISO and GMP.

3. Suzhou Asia Pharmaceutical Co., Ltd. – Located in China, this manufacturer supplies atropine sulfate APIs for ophthalmic formulations, emphasizing cost-effective manufacturing with consistent quality.

4. Yungjin Pharmaceutical Co., Ltd. – Another South Korean producer of atropine sulfate, Yungjin supplies APIs to various ophthalmic medication manufacturers worldwide, often serving as a reliable OEM supplier.

5. Sigma-Aldrich (part of Merck Group) – While primarily a distributor, Sigma-Aldrich supplies atropine sulfate for research and limited medicinal use, with certain products approved for pharmaceutical manufacturing. Their APIs often undergo rigorous quality assessment suitable for pharmaceutical production.

Formulation and Finished Product Manufacturers

Once the API is procured, several pharmaceutical companies formulate and package Isopto Atropine for distribution. These firms may be captive producers or contract manufacturers.

1. Alcon – A major player in ophthalmology, Alcon manufactures Isopto Atropine within its extensive global operations. Their manufacturing facilities adhere to stringent regulatory standards (FDA, EMA), ensuring high-quality finished products.

2. Somaxon Pharmaceuticals – In some markets, specialized companies formulate and distribute ophthalmic solutions based on atropine sulfate, either under their brand or as private-label products for pharmacy chains.

3. Contract Manufacturing Organizations (CMOs) – Various CMOs, such as Fareva, Recipharm, and Catalent, provide contract formulation and manufacturing for ophthalmic solutions, including atropine-based formulations, catering to pharmaceutical companies seeking scalable production.

Distribution and Supply Chain Dynamics

The supply of Isopto Atropine depends heavily on the global distribution network, regulatory approvals across different jurisdictions, and inventory management. Major pharmaceutical distributors like McKesson, Cardinal Health, and local regional distributors play crucial roles in ensuring timely availability for healthcare providers.

Geographical Considerations

• North America – The U.S. market relies heavily on APIs and finished products from North American and European suppliers, such as Alcon and Meda Pharmaceuticals. Regulatory approval via the FDA plays a critical role in supply stability.

• Europe – European suppliers benefit from stringent GMP standards, with companies like Alcon and regional contract manufacturers maintaining a steady supply channel aligned with EMA regulations.

• Asia-Pacific – A significant manufacturing hub due to lower production costs and high-capacity API producers, including Hanlim Pharmaceutical and Suzhou Asia Pharmaceutical, supplying both local and export markets.

• Emerging Markets – Countries in Africa, Latin America, and Southeast Asia often source APIs from China and India, with local compounding pharmacies and hospitals receiving supplies through regional distributors.

Regulatory and Quality Considerations

Suppliers must meet strict regulatory standards such as the FDA (U.S.), EMA (Europe), and regional GMP certifications to guarantee product safety, efficacy, and quality. API manufacturers like Catalent and Hanlim Pharmaceuticals maintain rigorous validation processes and robust documentation to facilitate regulatory approval. Finished product manufacturers must also adhere to these standards during formulation and packaging.

Strategic Procurement Insights

• Diversify Suppliers – To mitigate risks associated with geopolitical tensions, supply disruptions, or quality issues, pharmaceutical companies often diversify their API and finished product sourcing base.

• Quality Over Cost – Ensuring GMP compliance and consistent quality is paramount for ophthalmic drugs where sterility and precise concentration are critical. Cost savings should not compromise these standards.

• Supply Chain Visibility – Investing in supply chain monitoring systems enhances transparency, allowing stakeholders to anticipate shortages, validate sources, and ensure regulatory compliance.

• Regulatory Vigilance – Continuous monitoring of regulatory changes across jurisdictions helps suppliers and manufacturers maintain compliance, facilitating uninterrupted supply.

Future Outlook

The global demand for atropine-based ophthalmic medications is expected to grow modestly due to the aging population and increased prevalence of ophthalmic diseases requiring pupil dilation. Advances in biosimilar and generic formulations may influence supplier strategies, with established API manufacturers expanding their capacities to meet rising demand.

Emerging multi-source and third-party contract manufacturing models will likely intensify, emphasizing quality control and regulatory compliance. Additionally, supply chain resilience will become even more critical, prompting pharma companies to establish strategic partnerships with reliable API and finished product suppliers.

Key Takeaways

• The core suppliers of Isopto Atropine are API manufacturers like Catalent, Hanlim Pharmaceutical, Suzhou Asia Pharmaceutical, and Yungjin Pharmaceutical, with finished product manufacturing often conducted by large pharmaceutical companies such as Alcon or specialized CMOs.

• Geographic diversification of suppliers helps mitigate risks and ensure supply chain stability, especially with the presence of high-capacity manufacturers in China, South Korea, and India.

• Regulatory compliance and GMP standards are non-negotiable criteria for both API and finished product suppliers in the ophthalmic segment.

• Strategic sourcing, quality assurance, and supply chain transparency are key to maintaining consistent availability of Isopto Atropine in global markets.

• Anticipated growth in ophthalmic care will likely influence supplier capacity and operational strategies in the coming years.

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FAQs

1. Who are the leading suppliers of atropine sulfate API for Isopto Atropine?
Leading API suppliers include Catalent Pharma Solutions, Hanlim Pharmaceutical, Suzhou Asia Pharmaceutical, and Yungjin Pharmaceutical, each providing GMP-compliant atropine sulfate suitable for ophthalmic use.[1]

2. How do regulatory standards impact the supply chain of Isopto Atropine?
Regulatory standards such as FDA and EMA enforce strict GMP compliance, ensuring product safety and quality. Suppliers meeting these standards facilitate seamless approval and distribution across markets.[2]

3. Can I find generic or private-label versions of Isopto Atropine?
Yes, several regional generic manufacturers and contract manufacturers produce private-label or generic versions, provided they meet regulatory and quality standards.[3]

4. What risks are associated with the current supply chain for Isopto Atropine?
Risks include geopolitical tensions affecting supplier access, quality variability from secondary suppliers, and supply disruptions due to manufacturing issues or regulatory changes.[4]

5. How is the demand for Isopto Atropine expected to evolve?
Demand is anticipated to grow gradually with an aging global population and expanding ophthalmic diagnostic procedures, prompting suppliers to increase capacities and streamline supply chains.[5]

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References

1. [Pharmaceutical API Suppliers Database, 2022]
2. [U.S. FDA Chemistry, Manufacturing, and Controls (CMC) Guidance]
3. [European Medicines Agency (EMA) Guidelines on Ophthalmic Products]
4. [Supply Chain Risk Management in Pharma, International Journal of Pharmaceutics, 2021]
5. [Global Ophthalmic Market Report, IQVIA, 2022]