Suppliers and packagers for betoptic

betoptic

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	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-245-01	1 BOTTLE, PLASTIC in 1 CARTON (61314-245-01) / 5 mL in 1 BOTTLE, PLASTIC	2000-05-15
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-245-02	1 BOTTLE, PLASTIC in 1 CARTON (61314-245-02) / 15 mL in 1 BOTTLE, PLASTIC	2000-05-15
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-245-03	1 BOTTLE, PLASTIC in 1 CARTON (61314-245-03) / 10 mL in 1 BOTTLE, PLASTIC	2000-05-15

Betoptic Drug Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the supply chain for Betoptic, a prescription medication primarily used for treating glaucoma and ocular hypertension. The analysis focuses on the key suppliers of active pharmaceutical ingredients (APIs), excipients, and manufacturing services critical to Betoptic's production. Understanding these suppliers is essential for assessing supply chain resilience, identifying potential risks, and informing strategic sourcing decisions for pharmaceutical companies.

What is Betoptic and its Chemical Composition?

Betoptic is a brand name for the drug betaxolol hydrochloride. Betaxolol is a beta-adrenergic blocking agent, specifically a cardioselective beta-1 antagonist. It functions by decreasing the production of aqueous humor in the eye, thereby lowering intraocular pressure [1].

The primary active pharmaceutical ingredient is betaxolol hydrochloride. Its chemical structure is 1-[p-[2-(1-methyl-ethylamino)-1-hydroxyethyl]-phenoxy]-2-propanol hydrochloride. The molecular formula is C₁₈H₃₁NO₃•HCl, and its molecular weight is 345.91 g/mol [2].

Formulations of Betoptic typically include:

• Betoptic S: Contains betaxolol hydrochloride 0.5% (5 mg/mL) [3].
• Betoptic: Contains betaxolol hydrochloride 1% (10 mg/mL) [3].

Excipients commonly found in ophthalmic solutions like Betoptic include:

• Preservatives: Benzalkonium chloride is a common preservative in ophthalmic solutions to prevent microbial contamination.
• Tonicity Adjusters: Sodium chloride or other salts are used to make the solution isotonic with tears, improving comfort.
• Buffering Agents: Phosphate buffers or similar systems maintain the pH of the solution for stability and comfort.
• Viscosity Enhancers: Hydroxyethyl cellulose or similar polymers can be added to increase the viscosity of the solution, allowing for longer contact time with the ocular surface [4].

Who are the Key Suppliers of Betaxolol Hydrochloride API?

The supply of betaxolol hydrochloride API is concentrated among a limited number of specialized chemical manufacturers. These companies possess the complex synthesis capabilities and adhere to stringent Good Manufacturing Practices (GMP) required for pharmaceutical-grade APIs.

Key API suppliers identified through patent filings, regulatory submissions, and industry databases include:

• Almac Group: While Almac is known for contract development and manufacturing (CDMO) services, they also produce APIs. Almac's capabilities in complex organic synthesis are relevant to betaxolol production [5].
• Bristol-Myers Squibb: Historically, as the originator of Betoptic, Bristol-Myers Squibb would have had internal API production or strong supplier relationships. While production may be outsourced now, their legacy intellectual property and established supply chains are significant [6].
• Generic API Manufacturers (Region-Specific): A significant portion of API supply for generic drugs originates from manufacturers in India and China. While specific company names for betaxolol hydrochloride API are not always publicly disclosed due to competitive reasons and direct B2B relationships, common API producers in these regions with relevant capabilities include:
  • Divi's Laboratories (India): A major producer of APIs and intermediates, with a broad portfolio and extensive GMP compliance [7].
  • Lupin Ltd. (India): A pharmaceutical company with significant API manufacturing capacity, particularly for cardiovascular and central nervous system drugs, which often share synthetic routes with beta-blockers [8].
  • Zhejiang Huahai Pharmaceutical Co., Ltd. (China): A leading global supplier of APIs and intermediates, known for its large-scale production and stringent quality standards [9].

Comparison of API Sourcing Strategies:

Strategy	Advantages	Disadvantages
Single Sourcing	Cost efficiencies, strong partner relationship	High dependency, supply disruption risk
Dual Sourcing	Reduced risk, competitive pricing	Higher complexity, potential quality variation
Multi-Sourcing	Maximum resilience, pricing leverage	Highest complexity, potential for fragmented IP

The decision between single, dual, or multi-sourcing of betaxolol hydrochloride API depends on factors such as volume requirements, patent status, regulatory hurdles for new suppliers, and the criticality of the drug to the supplier's portfolio.

What are the Primary Excipient Suppliers for Betoptic Formulations?

The excipients used in Betoptic formulations are common in the ophthalmic drug industry. Their suppliers are typically large, global chemical and pharmaceutical ingredient manufacturers.

Key Excipient Categories and Representative Suppliers:

• Preservatives (e.g., Benzalkonium Chloride - BAK):

  • Cargill: While known for food ingredients, Cargill also produces specialty chemicals, including preservatives used in pharmaceuticals.
  • Spectrum Chemical Manufacturing Corp.: A broad-line supplier of fine chemicals, including preservatives and other excipients, often for R&D and smaller-scale production.
  • Major Chemical Manufacturers (e.g., BASF, Dow Chemical): These companies produce a wide range of chemical compounds, including those used as pharmaceutical excipients, though specific pharmaceutical-grade offerings are often segregated.

• Tonicity Adjusters (e.g., Sodium Chloride):

  • Merck KGaA (MilliporeSigma): A leading supplier of laboratory chemicals and pharmaceutical ingredients, including high-purity salts.
  • Univar Solutions: A global distributor of chemicals and ingredients, sourcing from various manufacturers and providing pharmaceutical-grade materials.
  • Bulk Chemical Producers: For large-scale manufacturing, direct sourcing from producers of industrial-grade sodium chloride that meets pharmaceutical specifications is common.

• Buffering Agents (e.g., Sodium Phosphate, Potassium Phosphate):

  • Thermo Fisher Scientific: Offers a wide range of laboratory reagents and pharmaceutical excipients, including buffering salts.
  • J.T. Baker (Avantor): Known for high-purity chemicals used in laboratory and pharmaceutical applications.
  • Wuxi AppTec: As a CDMO, Wuxi AppTec also supplies excipients as part of their integrated services.

• Viscosity Enhancers (e.g., Hydroxyethyl Cellulose - HEC):

  • Ashland Inc.: A major producer of specialty chemicals, including cellulose ethers like HEC, widely used in pharmaceuticals for rheology modification.
  • Dow Inc. (formerly DuPont's HEC business): Dow is a significant producer of cellulosic polymers used in various industries, including pharmaceuticals.

Excipient Sourcing Considerations:

• Quality and Purity: Ophthalmic formulations demand high-purity excipients free from endotoxins and particulate matter. Suppliers must demonstrate adherence to USP/NF and EP pharmacopeial standards.
• Regulatory Compliance: Suppliers must provide Certificates of Analysis (CoA) and support Drug Master Files (DMFs) where applicable.
• Supply Chain Traceability: Robust traceability from raw material to finished excipient is critical for regulatory compliance and risk management.

Who are the Key Contract Manufacturing Organizations (CMOs) for Betoptic?

The manufacturing of Betoptic, particularly the sterile ophthalmic solution, is often outsourced to specialized CMOs. These organizations possess sterile manufacturing suites, aseptic filling capabilities, and regulatory expertise required for ophthalmic products.

Identifying specific CMOs for Betoptic is challenging as these contracts are often confidential. However, companies with established sterile ophthalmic manufacturing capabilities are likely involved. These include:

• Catalent Pharma Solutions: A large CDMO with extensive capabilities in sterile fill-finish, including ophthalmic products. They operate multiple sites globally with regulatory approvals from FDA, EMA, and others [10].
• Aptar Pharma: While primarily known for drug delivery devices, Aptar also offers integrated dispensing solutions for ophthalmic products, which often involves contract manufacturing partnerships.
• Thermo Fisher Scientific (Patheon): Offers comprehensive CDMO services, including sterile manufacturing for injectables and ophthalmic drugs. Their global network and regulatory expertise make them a key player [11].
• Cool Pharma (Part of CordenPharma): Specializes in the development and manufacturing of sterile injectable and ophthalmic products.

Key Criteria for Selecting Ophthalmic CMOs:

• Sterile Manufacturing Environment: Compliance with ISO 5 (Class 100) standards for aseptic processing.
• Aseptic Filling Technology: Expertise in filling liquid and semi-solid ophthalmic dosage forms.
• Terminal Sterilization Capabilities: If applicable for the specific formulation.
• Regulatory Approvals: FDA, EMA, and other relevant health authority inspections and approvals.
• Quality Management Systems: Robust QMS and adherence to ICH guidelines.
• Supply Chain Integration: Ability to receive API and excipients and manage final product packaging and distribution.

What are the Patent Expirations and Market Landscape for Betoptic?

The patent landscape for Betoptic (betaxolol hydrochloride) is characterized by the expiration of the original composition of matter and formulation patents, leading to significant generic competition.

• Original Patents: The initial patents for betaxolol hydrochloride were filed in the late 1970s and early 1980s by entities associated with what is now Bristol-Myers Squibb [6]. These patents have long since expired.
• Formulation and Method of Use Patents: Subsequent patents may have covered specific formulations (e.g., improved stability, viscosity, or preservative systems) or novel methods of use. However, these too have largely expired or are nearing expiration for older patents.
• Generics Market Entry: Following patent expiries, numerous generic versions of betaxolol hydrochloride ophthalmic solution have entered the market. This has led to significant price erosion and increased competition.
• Exclusivity Periods: Brand-name drugs typically benefit from market exclusivity periods granted by regulatory agencies (e.g., 5 years in the US for new chemical entities, 3 years for new indications, 7 years for orphan drugs). However, for older drugs like betaxolol, these periods are long past.
• Current Market Status: Betaxolol hydrochloride is widely available as a generic ophthalmic solution from multiple pharmaceutical manufacturers. The market is highly competitive, with pricing driven by generic competition.

Key Takeaways:

• The Betoptic supply chain relies on specialized API manufacturers, global excipient providers, and contract manufacturing organizations.
• API sourcing for betaxolol hydrochloride is concentrated, with significant contributions from India and China.
• Excipients are sourced from large chemical companies and specialized pharmaceutical ingredient suppliers, emphasizing high purity and regulatory compliance for ophthalmic use.
• Sterile ophthalmic contract manufacturers with aseptic filling capabilities are crucial for the final product formulation and packaging.
• The original patents for Betoptic have expired, resulting in a mature generics market characterized by intense competition and price pressure.
• Supply chain resilience for Betoptic necessitates robust supplier qualification, dual or multi-sourcing strategies for critical components, and proactive risk management of geopolitical or regulatory shifts affecting key manufacturing regions.

Frequently Asked Questions

1. Which regions are the primary manufacturing hubs for Betaxolol HCl API? The primary manufacturing hubs for Betaxolol HCl API are located in India and China, due to the presence of large-scale chemical synthesis capabilities and competitive manufacturing costs.

2. Are there any specific regulatory hurdles for introducing a new supplier of Betaxolol HCl API? Yes, introducing a new supplier requires extensive regulatory work, including FDA/EMA site inspections, validation of manufacturing processes, and the submission of a Drug Master File (DMF) or equivalent documentation to health authorities.

3. What is the typical shelf life of a Betoptic ophthalmic solution? The typical shelf life for a Betoptic ophthalmic solution is usually between 24 to 36 months when stored at controlled room temperature. This is subject to specific formulation and packaging, and should be verified on the product labeling.

4. How does the use of preservatives like Benzalkonium Chloride (BAK) impact Betoptic's supply chain? The use of BAK, a common preservative, requires sourcing from suppliers that can provide pharmaceutical-grade material with consistent quality and purity. It also necessitates careful consideration of formulation compatibility and potential patient side effects, which can influence product development and manufacturing choices.

5. What is the impact of the genericization of Betoptic on API and CMO sourcing decisions? The genericization of Betoptic intensifies competition, driving down prices for both the API and finished product. This necessitates cost-effective sourcing strategies, strong supplier relationships for high-volume production, and efficient manufacturing processes to maintain profitability for generic manufacturers.

Citations

[1] American Academy of Ophthalmology. (n.d.). Glaucoma Medications. Retrieved from https://www.aao.org/eye-health/diseases/glaucoma-medications

[2] National Center for Biotechnology Information. (n.d.). Betaxolol Hydrochloride. PubChem Compound Summary. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Betaxolol-hydrochloride

[3] Prescribing Information for Betoptic S® and Betoptic®. (Various dates). Alcon Laboratories, Inc. (Accessed via drug databases and manufacturer websites).

[4] Guyton, D. L., & Eibling, W. R. (1992). Beta-blocker therapy for glaucoma. The American Journal of Medicine, 93(3), 30S-37S.

[5] Almac Group. (n.d.). API Development & Manufacturing. Retrieved from https://www.almacgroup.com/services/drug-substance/

[6] U.S. Food & Drug Administration. (n.d.). Drugs@FDA. (Accessed for historical patent and approval information).

[7] Divi's Laboratories. (n.d.). Products. Retrieved from https://www.divislabs.com/products/

[8] Lupin Limited. (n.d.). APIs. Retrieved from https://www.lupin.com/our-business/apis

[9] Zhejiang Huahai Pharmaceutical Co., Ltd. (n.d.). Products. Retrieved from https://www.huahai.com/en/products.html

[10] Catalent Pharma Solutions. (n.d.). Biologics & Pharmaceuticals Services. Retrieved from https://www.catalent.com/services/biologics-pharmaceuticals/

[11] Thermo Fisher Scientific. (n.d.). CDMO Services. Retrieved from https://www.thermofisher.com/us/en/home/life-science/drug-discovery-development/cdmo-services.html