Suppliers and packagers for COSOPT

COSOPT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869	NDA	Thea Pharma Inc.	82584-605-10	1 BOTTLE, DROPPER in 1 CARTON (82584-605-10) / 10 mL in 1 BOTTLE, DROPPER	2022-11-10

Suppliers for the Pharmaceutical Drug: COSOPT

Last updated: July 28, 2025

Introduction

COSOPT is a prescription medication combining dorzolamide hydrochloride and timolol maleate, primarily indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Recognized for its role in ocular pharmacology, COSOPT's supply chain involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, formulation developers, and distributors. Understanding key suppliers in this chain is crucial for stakeholders aiming to ensure product integrity, regulatory compliance, and supply security.

Active Pharmaceutical Ingredient (API) Suppliers

The core strength of COSOPT’s formulation rests on high-quality API manufacturing. Dorzolamide hydrochloride and timolol maleate each have dedicated suppliers globally, many of which are large, established pharmaceutical companies with extensive GMP (Good Manufacturing Practices) certifications.

• Dorzazolamide Hydrochloride Suppliers:
  Leading API manufacturers such as Aspen Pharmacare, Sun Pharmaceutical Industries, and Sandoz produce dorzolamide hydrochloride. These companies operate manufacturing sites in India and Europe, leveraging robust GMP standards to ensure purity and stability. For instance, Sandoz, a Novartis division, maintains manufacturing facilities certified by global regulatory agencies.

• Timolol Maleate Suppliers:
  Suppliers like Mylan (now part of Viatris), Hetero Labs, and Aurobindo Pharma supply timolol maleate. These firms, based predominantly in India and the United States, possess advanced chemical synthesis capabilities, with many holding stringent regulatory approvals from the FDA and EMA.

Formulation and Filler Suppliers

In addition to APIs, excipients and other formulation components are essential. These include buffering agents, stabilizers, and preservatives.

• Excipients and Preservatives:
  Major excipient manufacturers such as BASF, Dow Chemical, and Evonik Industries supply substances like sodium biocarbonate and benzalkonium chloride critical in ophthalmic formulations.

Manufacturing and Contract Development Organizations (CDOs)

Pharmaceutical companies often rely on contract manufacturing organizations to produce stable, capsule-ready or bottle-formulated dosages of COSOPT.

• Contract Manufacturers:
  Firms like Famar, Viatris Manufacturing sites, and Dr. Reddy’s Laboratories undertake dosage form manufacturing, leveraging their expertise in sterile ophthalmic formulation.

Distribution and Wholesale Suppliers

Reliable distribution channels are vital to maintain supply continuity.

• Global Distributors:
  Major distributors such as McKesson, Cardinal Health, and Alliance Healthcare handle logistics for COSOPT, ensuring availability across hospitals, clinics, and pharmacies worldwide.

• Regional and Local Distributors:
  These entities often operate under regional regulatory frameworks, ensuring compliance and timely supply within specific territories.

Regulatory and Quality Certification

Suppliers of COSOPT and its components are typically required to meet certifications such as ISO 9001, ISO 13485 (for medical devices), and national drug approval standards (FDA, EMA, PMDA). Manufacturers with such credentials demonstrate adherence to quality and manufacturing standards essential for ophthalmic medications.

Supply Chain Challenges and Considerations

• Regulatory Variability:
  Suppliers operating across regions must navigate different regulatory standards, which can affect the consistency and approval timelines for APIs and finished products.

• Supply Stability:
  Dependence on geographically concentrated API suppliers, especially from India and China, introduces risks related to geopolitical tensions, trade policies, and pandemic-related disruptions.

• Patent and Regulatory Changes:
  Patent expirations and evolving regulations can impact supplier dynamics, opening gaps or new opportunities within the supply chain.

Emerging Suppliers and Market Trends

• Biotech and Novel Formulations:
  As biosimilars and alternative formulations develop, new API suppliers and formulation experts enter the market. Companies investing in advanced manufacturing platforms may become significant future supply partners.

• Vertical Integration:
  Certain pharmaceutical companies are consolidating API manufacturing and formulation operations internally to mitigate supply risks and ensure quality control.

Conclusion

The supply chain of COSOPT involves a complex network of reputable API manufacturers, formulation specialists, and distributors operating under stringent regulatory standards. Stakeholders aiming for secure supply chains should prioritize verified suppliers with proven GMP certifications, stable production capacities, and compliance with international regulatory frameworks. In light of global supply challenges, engaging diversified suppliers and establishing strategic partnerships remains advisable for uninterrupted COSOPT availability.

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Key Takeaways

• Reputable API Suppliers: Major firms like Sandoz, Aspen Pharmacare, Mylan, and Hetero Labs dominate the supply of dorzolamide hydrochloride and timolol maleate, the core APIs of COSOPT.
• Quality Assurance: Suppliers with stringent GMP and international certification mitigate risks of contamination or substandard quality.
• Supply Chain Resilience: Diversifying suppliers and assessing geopolitical influences enhance supply stability amid global disruptions.
• Regulatory Compliance: Continuous monitoring of regulatory approvals is essential, especially with patent expirations and market entry of generics.
• Emerging Market Trends: Innovations in formulation and increased vertical integration could shift supplier dynamics, offering new opportunities.

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FAQs

1. Who are the primary API suppliers for COSOPT?
Leading API manufacturers for COSOPT include Sandoz (Novartis), Aspen Pharmacare, Sun Pharmaceutical Industries, Mylan (Viatris), and Hetero Labs, all recognized for their GMP-compliant production of dorzolamide hydrochloride and timolol maleate.

2. How do quality standards impact supplier selection?
Suppliers with ISO certifications, GMP compliance, and regulatory approvals from agencies like the FDA or EMA ensure product quality, safety, and consistent efficacy. This reduces risks associated with contamination and regulatory non-compliance.

3. Are there regional differences in COSOPT suppliers?
Yes. Many API suppliers are based in India and Europe, with pharmaceutical manufacturing hubs globally. Regional regulatory requirements influence supplier choice and product registration.

4. What are the current challenges in the COSOPT supply chain?
Challenges include fluctuations in API availability due to geopolitical tensions, supply disruptions from pandemics, regulatory delays, and patent-related market shifts favoring generics.

5. Is the supply chain for COSOPT expected to evolve?
Yes. Advances in biotechnology, new formulation techniques, and vertical integration strategies may diversify and strengthen future supply chains, ensuring greater resilience and innovation.

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Sources:

1. [1] US Food and Drug Administration (FDA) – Approved Drug Products.
2. [2] European Medicines Agency (EMA) – Regulatory Requirements for Ophthalmic Drugs.
3. [3] Global Pharmaceutical Supply Chain Reports, IQVIA.
4. [4] Company Annual Reports: Sandoz, Aspen Pharmacare, Mylan, Hetero Labs.

Note: The information presented is compiled from publicly available industry data and regulatory filings as of the knowledge cutoff in 2023.