Suppliers and packagers for ISOPTO CARPINE

ISOPTO CARPINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	ISOPTO CARPINE	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	200890	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-203-15	1 BOTTLE in 1 CARTON (61314-203-15) / 15 mL in 1 BOTTLE	2011-09-30
Sandoz	ISOPTO CARPINE	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	200890	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-204-15	1 BOTTLE in 1 CARTON (61314-204-15) / 15 mL in 1 BOTTLE	2011-09-30
Sandoz	ISOPTO CARPINE	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	200890	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-206-15	1 BOTTLE in 1 CARTON (61314-206-15) / 15 mL in 1 BOTTLE	2011-09-30

Suppliers for the Pharmaceutical Drug: ISOPTO CARPINE

Last updated: August 2, 2025

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Overview of ISOPTO CARPINE

ISOPTO CARPINE is a well-established ophthalmic medication, primarily containing pilocarpine chloride. It is used to treat glaucoma and ocular hypertension by reducing intraocular pressure. Due to its critical role in ocular health, demand for ISOPTO CARPINE remains steady. The drug is typically supplied through a global network of pharmaceutical manufacturers and distributors with rigorous quality controls, given the sensitive nature of ophthalmic drugs.

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Global Manufacturing and Licensing Landscape

The supply chain for ISOPTO CARPINE hinges on key licensed producers authorized by regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national regulatory agencies. The original formulation was developed and marketed by Alcon, a leader in ophthalmic pharmaceuticals, which held the original patent rights and manufacturing licenses. When patents expire, generic manufacturers enter the fray, expanding supply options.

Key Suppliers and Manufacturers

1. Alcon (Novartis Group)

Alcon historically manufactured ISOPTO CARPINE under its own brand, leveraging its extensive ophthalmic portfolio. As a pioneer in this sector, Alcon remains a significant supplier, particularly in regions where it retains manufacturing and licensing rights. Their emphasis on quality and proven manufacturing standards make them a reliable source for pharmaceutical distributors and hospitals.

2. Generic Manufacturers

Following patent expiration, multiple generic pharmaceutical companies have entered the market, increasing supply chain options for ISOPTO CARPINE. These companies produce pilocarpine chloride ophthalmic solutions under their own labels, often at reduced costs, expanding access globally. Key players include:

• Sandoz (a Novartis division): Known for high-quality generics, Sandoz produces pilocarpine ophthalmic solutions compliant with international standards.

• Sun Pharmaceutical Industries: A major Indian pharmaceutical company offering ophthalmic generics, including pilocarpine solutions, with significant market penetration in developing regions.

• Pfizer: Historically, Pfizer has been involved in ophthalmology, though their direct production of pilocarpine ophthalmics is limited; nonetheless, they have licensed manufacturing partners.

• Teva Pharmaceutical Industries: As a leading generic drug producer, Teva supplies pilocarpine formulations in various markets, adhering to regulatory standards.

• Laboratories Karim (India): Known for affordable ophthalmic generics, Karim manufactures pilocarpine solutions distributed globally, especially in emerging markets.

3. Regional Distributors and Local Manufacturers

In addition to large pharmaceutical companies, regional distributors and local manufacturers often produce or distribute ISOPTO CARPINE, especially in jurisdictions with strong compounding pharmacies or where local regulatory agencies allow compounded formulations. Such sources include:

• Local compounding pharmacies in North America, Europe, and Asia often prepare customized pilocarpine solutions, although these are considered non-regulated compounded preparations and may lack consistent quality assurance.

• Asian manufacturers, particularly in India and China, produce pilocarpine ophthalmic solutions that are imported into various emerging markets, regulated under local pharmaceutical standards.

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Supply Chain Considerations

Regulatory Approvals

Suppliers must possess current approval from pertinent authorities like the FDA, EMA, or local agencies such as India's CDSCO or China's NMPA. Regulatory compliance ensures the drug meets safety, efficacy, and stability standards.

Manufacturing Capacity and Quality Assurance

The primary suppliers maintain cGMP (current Good Manufacturing Practice) compliance and operate manufacturing plants with rigorous quality control protocols. Disruptions due to regulatory issues, manufacturing outages, or geopolitical circumstances can impact supply continuity.

Pricing and Market Dynamics

Generic manufacturers often offer competitive pricing, influencing the procurement strategies of hospitals and pharmacies. Price fluctuations can also emerge from raw material costs, especially for pilocarpine chloride, which affects overall supply stability.

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Supply Chain Challenges and Outlook

Global shortages of ocular medications have periodically impacted the availability of ISOPTO CARPINE, driven by factors like manufacturing delays, regulatory interventions, or supply chain disruptions caused by geopolitical tensions and the COVID-19 pandemic. The industry’s shift toward biosimilars and generics has increased supply options; however, maintaining supply safety and quality remains paramount.

Emerging markets increasingly rely on local or regional suppliers, often with less stringent quality controls, which can impact drug efficacy and safety. Conversely, large multinational corporations continue to dominate the supply landscape in developed markets, ensuring high standards.

The future of ISOPTO CARPINE supply hinges on sustained manufacturing capacity, global regulatory harmonization, and ongoing research into alternative formulations or delivery methods that could further diversify the supply chain.

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Key Takeaways

• Primary suppliers of ISOPTO CARPINE include established players such as Alcon, supplemented by generics manufacturers like Sandoz, Sun Pharma, Teva, and local producers, especially in emerging markets.
• Regulatory compliance is critical; suppliers must hold necessary approvals to ensure quality, safety, and efficacy.
• Market dynamics favor affordable generics, positioning them as dominant sources in many regions, although supply stability depends on raw material availability and manufacturing capacity.
• Supply chain vulnerabilities—such as disruptions from geopolitical or health crises—necessitate diversified sourcing strategies.
• Ongoing developments in pharmaceutical manufacturing, regulation, and supply chain logistics will continue to influence the availability of ISOPTO CARPINE.

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FAQs

1. Who are the leading global manufacturers of ISOPTO CARPINE?
Leading manufacturers include Alcon (Novartis), Sandoz (Novartis division), Sun Pharma, Teva, and Laboratories Karim, among others. These companies hold licenses or produce generics widely available across different markets.

2. Are there regional differences in suppliers of ISOPTO CARPINE?
Yes. Developed markets typically rely on licensed multinational manufacturers like Alcon and Sandoz, while emerging markets may depend on regional or local generic producers such as Indian or Chinese firms.

3. How does regulatory approval impact supplier credibility?
Regulatory approval from agencies like the FDA or EMA ensures manufacturing quality and safety standards, directly affecting supplier credibility and product reliability.

4. Can compounded formulations of pilocarpine be considered reliable?
While compounded formulations are sometimes used locally, they lack the rigorous quality assurance of commercially manufactured products and are not preferred for systemic or long-term treatment due to variability risks.

5. What is the future outlook for ISOPTO CARPINE supply?
The supply landscape is expected to stabilize with increased generic manufacturing, but vigilance is necessary regarding raw material procurement, regulatory changes, and potential supply chain disruptions. Diversification of sources remains crucial for ensuring consistent availability.

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References

1. [1] "Ophthalmic Drugs Market Overview," Statista, 2022.
2. [2] "Global Pharmaceutics and Drug Delivery," Pharmaceutical Technology, 2021.
3. [3] "FDA Approved Ophthalmic Medications," U.S. Food and Drug Administration, 2023.
4. [4] "Indian Pharmaceutical Industry and Generics," Pharmexcil Report, 2022.
5. [5] "Supply Chain Challenges in Ophthalmic Medications," Deloitte Insights, 2022.