carteolol hydrochloride: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	CARTEOLOL HYDROCHLORIDE	carteolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	075476	ANDA	Sandoz Inc	61314-238-05	5 mL in 1 BOTTLE, PLASTIC (61314-238-05)	2000-01-05
Sandoz	CARTEOLOL HYDROCHLORIDE	carteolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	075476	ANDA	Sandoz Inc	61314-238-10	10 mL in 1 BOTTLE, PLASTIC (61314-238-10)	2000-01-05
Sandoz	CARTEOLOL HYDROCHLORIDE	carteolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	075476	ANDA	Sandoz Inc	61314-238-15	15 mL in 1 BOTTLE, PLASTIC (61314-238-15)	2000-01-05
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This analysis identifies primary suppliers of Carteolol Hydrochloride active pharmaceutical ingredient (API) and examines the relevant patent landscape. Key findings indicate a consolidated supply chain with limited primary manufacturers and a patent landscape with expired foundational patents and ongoing formulation-based intellectual property.

Who are the primary manufacturers of Carteolol Hydrochloride API?

The global supply of Carteolol Hydrochloride API is concentrated among a few manufacturers. These suppliers are critical to the production of finished dosage forms for the ophthalmic market.

Manufacturer Name	Location	Primary Product	Manufacturing Capacity (Estimated)	Notes
Sarex Overseas	India	Carteolol Hydrochloride API	N/A	Registered with multiple regulatory agencies.
Abbott Laboratories	United States	N/A	N/A	Historically a significant player; current API manufacturing status requires direct inquiry.
Laboratorio Farmaceutico C.T. SRL	Italy	Carteolol Hydrochloride API	N/A	Focus on generic API production.
Anqiu Hesheng Pharmaceutical Co., Ltd.	China	Carteolol Hydrochloride API	N/A	Active supplier in the Asian market; regulatory filings in progress.

Note: Manufacturing capacity figures are not publicly disclosed by most API manufacturers. The status of Abbott Laboratories' direct API manufacturing for Carteolol Hydrochloride necessitates direct engagement.

What is the patent status for Carteolol Hydrochloride?

The foundational patents covering the synthesis and composition of Carteolol Hydrochloride have expired. However, intellectual property remains relevant through patents related to specific formulations, delivery systems, and manufacturing processes.

Key Patent Categories for Ophthalmic Drugs

Composition of Matter Patents: These patents protect the chemical structure of the drug itself. The original patents for Carteolol Hydrochloride have expired.
Formulation Patents: These patents cover specific ways the drug is prepared for administration. For ophthalmic drugs, this often includes aspects like pH, viscosity, excipients, and methods to enhance solubility or penetration.
Method of Treatment Patents: These patents protect the use of a drug for a specific medical condition. While Carteolol Hydrochloride is established for glaucoma, new or improved methods of use could be patented.
Process Patents: These patents protect specific methods of manufacturing the drug or its dosage forms, potentially offering improvements in purity, yield, or cost-effectiveness.

Historical Patent Milestones for Carteolol Hydrochloride

Original Synthesis and Composition: The initial patents for Carteolol Hydrochloride were filed in the late 1970s and early 1980s. These patents have long since expired. For example, U.S. Patent 4,092,425, describing beta-adrenergic blocking agents including Carteolol, was granted in 1978. The term of this patent would have expired in the late 1990s.

Current Patent Activity Analysis

Current patent filings related to Carteolol Hydrochloride primarily focus on:

Improved Ophthalmic Formulations:
- Preservative-Free Formulations: Patents address the development of preservative-free eye drops, which are beneficial for patients with sensitive eyes or frequent users. These formulations often require specific stabilizing agents and manufacturing techniques.
- Sustained-Release Systems: Research and patents are exploring novel drug delivery systems that allow for less frequent administration, such as ocular implants or specialized gels, though these are less common for Carteolol compared to newer agents.
- Combinations with Other Ophthalmic Agents: Patents may cover fixed-dose combinations of Carteolol Hydrochloride with other anti-glaucoma medications to improve patient compliance and therapeutic outcomes.
Manufacturing Process Enhancements:
- Patents may exist for more efficient or environmentally friendly synthesis routes for Carteolol Hydrochloride API.
- Specific purification techniques that result in higher purity API or reduced impurity profiles can also be patented.

Example of a Formulation Patent Type:

A hypothetical formulation patent might claim: "An ophthalmic composition comprising Carteolol Hydrochloride, a buffering agent to maintain a pH between X and Y, and a viscosity enhancer to achieve a Brookfield viscosity of Z centipoise at 25°C, said composition being sterile and preservative-free."

Strategic Implications of the Patent Landscape:

The absence of dominant composition of matter patents creates opportunities for generic manufacturers to enter the market.
Companies can differentiate their products by developing novel formulations that offer advantages such as improved stability, enhanced patient comfort, or reduced side effects.
Process patents can provide a competitive edge by lowering manufacturing costs or improving product quality.

How does regulatory approval impact supplier selection for Carteolol Hydrochloride?

Regulatory approvals, primarily from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are critical for supplier qualification and market access.

Key Regulatory Considerations

Drug Master Files (DMFs): API manufacturers must submit DMFs to regulatory agencies. These confidential documents contain detailed information about the manufacturing process, quality control, and stability of the API. The FDA reviews DMFs in conjunction with an Abbreviated New Drug Application (ANDA) for a generic drug or a New Drug Application (NDA).
Good Manufacturing Practices (GMP): Facilities producing Carteolol Hydrochloride API must adhere to strict GMP guidelines. Regulatory inspections verify compliance with these standards.
Certificate of Suitability (CEP): In Europe, a CEP issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) demonstrates that the API complies with the requirements of the European Pharmacopoeia. This simplifies the regulatory process for finished product manufacturers.
Inspections and Audits: Pharmaceutical companies conduct their own audits of API suppliers to ensure quality, reliability, and compliance with their internal standards. These audits often precede or supplement regulatory inspections.

Impact on Supplier Selection

FDA Approved DMF: An API supplier with an approved or actively reviewed DMF with the FDA is generally preferred for the U.S. market.
EMA/EDQM Compliance: For European markets, suppliers with CEPs or those able to demonstrate EMA compliance are essential.
Established GMP Track Record: Suppliers with a history of successful regulatory inspections and a strong GMP compliance record are considered lower risk.
Traceability and Quality Control: Robust quality management systems, including comprehensive batch traceability and analytical testing protocols, are mandatory.

Supplier Assessment Checklist:

Regulatory Filings: DMF status (FDA), CEP (EMA).
GMP Compliance: Recent inspection reports, CAPA (Corrective Action/Preventive Action) plans.
Quality Systems: ISO certifications, internal audit history.
Supply Chain Security: Redundancy in manufacturing, raw material sourcing.
Technical Support: Ability to provide analytical data, process insights.

What are the commercial implications for Carteolol Hydrochloride supply?

The commercial landscape for Carteolol Hydrochloride is characterized by a mature generic market, competition focused on cost and quality, and strategic considerations for long-term supply stability.

Market Dynamics

Generic Competition: As a well-established drug, Carteolol Hydrochloride is available from multiple generic manufacturers. This intensifies price competition among finished dosage form producers.
Cost of Goods Sold (COGS): The price of the API is a significant component of the COGS for generic Carteolol Hydrochloride eye drops. Lower API costs directly translate to higher profit margins or more competitive pricing for the finished product.
Quality and Reliability: While cost is a major factor, consistent API quality and a reliable supply chain are paramount. Disruptions in API supply can lead to stock-outs and loss of market share.

Strategic Sourcing Considerations

Dual Sourcing: To mitigate supply chain risks, pharmaceutical companies often employ dual sourcing strategies, securing API from at least two qualified suppliers. This diversifies risk associated with a single supplier's production issues, regulatory problems, or geopolitical instability.
Supplier Relationship Management: Building strong relationships with key API suppliers can lead to better pricing, preferential allocation during shortages, and collaborative problem-solving.
Geographic Diversification: Relying on suppliers from different geographic regions can reduce vulnerability to localized events (e.g., natural disasters, trade disputes, or regulatory changes in a specific country). India and China are significant API manufacturing hubs, but understanding their specific regulatory environments and potential risks is crucial.
Long-Term Supply Agreements: Negotiating long-term supply agreements can secure favorable pricing and guarantee supply volumes, providing stability for commercial planning.

Market Trends

Focus on Purity and Impurities: Regulatory agencies are increasingly scrutinizing API impurity profiles. Suppliers with advanced analytical capabilities and robust impurity control strategies are gaining favor.
Demand for Preservative-Free Formulations: The shift towards preservative-free ophthalmic products drives demand for specific API characteristics and potentially specialized manufacturing processes that ensure sterility and stability without preservatives.
Emerging Markets: While the primary markets are well-established, growth opportunities exist in emerging economies as healthcare access expands. Suppliers must be prepared to meet the regulatory requirements of these diverse markets.

Key Takeaways

The global supply of Carteolol Hydrochloride API is concentrated among a limited number of manufacturers, primarily located in India and Italy, with significant historical involvement from U.S. entities.
The foundational patent protection for Carteolol Hydrochloride has expired, opening the market to generic competition.
Current intellectual property activity focuses on formulation enhancements, such as preservative-free solutions and combination therapies, and process improvements.
Regulatory compliance, evidenced by DMF filings with the FDA and CEPs from the EDQM, is a critical prerequisite for API suppliers.
Commercial strategies for Carteolol Hydrochloride emphasize cost optimization, robust quality control, and supply chain resilience through dual sourcing and long-term agreements.

Frequently Asked Questions

Are there any active patents that prevent the manufacturing of Carteolol Hydrochloride API? No, the primary patents covering the chemical composition and synthesis of Carteolol Hydrochloride have expired, allowing for generic API production.
What is the typical lead time for securing a new API supplier for Carteolol Hydrochloride? The lead time can range from 6 to 18 months, depending on the supplier's qualification status, the client's regulatory requirements, and the need for site audits and initial batch validations.
How do regulatory changes in API manufacturing impact Carteolol Hydrochloride suppliers? Suppliers must continually adapt to evolving GMP standards and impurity guidelines. Failure to comply can result in import alerts or product recalls, impacting their ability to serve regulated markets.
What are the main risks associated with relying on a single supplier for Carteolol Hydrochloride API? Risks include potential supply chain disruptions due to manufacturing issues, regulatory non-compliance, geopolitical events, or natural disasters affecting the supplier's region.
Does the demand for preservative-free Carteolol Hydrochloride eye drops influence API specifications? While not directly altering the chemical structure of the API, demand for preservative-free formulations may place greater emphasis on the API's purity profile and its compatibility with sterile manufacturing processes and specific excipients used in preservative-free formulations.

Citations

[1] U.S. Patent 4,092,425. (1978). Beta-adrenergic blocking agents. United States Patent Office.

Suppliers and packagers for generic pharmaceutical drug: carteolol hydrochloride